1 文献来源 Saghir Z, Dirksen A, screening for lung cancer disease. The randomised Ashraf H, et al. CT brings forward early Danish Lung Cancer Screening Trial: Status after five annual screening rounds with low-dose ...1 文献来源 Saghir Z, Dirksen A, screening for lung cancer disease. The randomised Ashraf H, et al. CT brings forward early Danish Lung Cancer Screening Trial: Status after five annual screening rounds with low-dose CT[J]. Thorax, 2012,67 (4) : 296-301.展开更多
Objective: To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang (FZGBF), for treating advanced non-small-cell lung cancer. Methods: A total of 84 eligible patients...Objective: To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang (FZGBF), for treating advanced non-small-cell lung cancer. Methods: A total of 84 eligible patientswere enrolled from October 2013 to July 2016. Patients were randomized to receive either chemotherapy alone as thecontrol group or chemotherapy combined with FZGBF as the experimental group. The primary endpoint of the study wasquality of life (QOL) and progression-free survival (PFS). Secondary endpoints were tumor response rate, toxicity,dropout rate, and univariate and multivariate analyses of clinicopathologic factors for QOL and PFS. Results: There wasa significant improvement in QOL, including better overall health (P 〈 0.001), physical function (P 〈 0.001), rolefunction (P 〈 0.001), emotional function (P 〈 0.001), cognitive function (P 〈 0.001), and social function (P = 0.031).Less fatigue, nausea or vomiting, insomnia, appetite loss, constipation, and alopecia were noted (All P 〈 0.001) whenFZGBF was combined with chemotherapy in comparison to chemotherapy alone. The experimental group had a betterPFS compared with the control group (P = 0.032). There was no significant difference in tumor response rate. FZGBFsignificantly reduced chemotherapy-induced anemia (P 〈 0.001), neutropenia (P = 0.023), nausea and vomiting (P 〈0.001). The use of Chinese herbal compounds had only mild side effects. In this study, factors influencing QOL were theuse of the Chinese herbal compounds (P 〈 0.001), performance status score (P = 0.027), clinical staging of cancer (P =0.009), and sex (P = 0.044). Use of traditional Chinese medicine (P = 0.043) and the number of previous chemotherapysessions (P = 0.003) were the factors influencing PFS in this study. Conclusion: FZGBF could improve QOL,compliance to treatment, relieved chemotherapy-related toxicities of patients, and consequently improved PFS, which isa promising drug combination in complementary medicine for the treatment of advanced NSCLC.展开更多
The effect of portal vein tumor thrombus(PVTT) on the prognosis of patients with hepatocellular carcinoma has become clear over the past several decades. However, identifying the mechanisms and performing the diagnosi...The effect of portal vein tumor thrombus(PVTT) on the prognosis of patients with hepatocellular carcinoma has become clear over the past several decades. However, identifying the mechanisms and performing the diagnosis and treatment of PVTT remain challenging. Therefore, this study aimed to summarize the progress in these areas. A computerized literature search in Medline and EMBASE was performed with the following combinations of search terms: "hepatocellular carcinoma" AND "portal vein tumor thrombus." Although several signal transduction or molecular pathways related to PVTT have been identified, the exact mechanisms of PVTT are still largely unknown. Many biomarkers have been reported to detect microvascular invasion, but none have proved to be clinically useful because of their low accuracy rates. Sorafenib is the only recommended therapeutic strategy in Western countries. However, more treatment options are recommended in Eastern countries, including surgery, radiotherapy(RT), transhepatic arterial chemoembolization(TACE), transarterial radioembolization(TARE), and sorafenib. Therefore, we established a staging system based on the extent of portal vein invasion. Our staging system effectively predicts the long-term survival of PVTT patients. Currently, several clinical trials had shown that surgery is effective and safe in some PVTT patients. RT,TARE, and TACE can also be performed safely in patients with good liver function. However, only a few comparative clinical trials had compared the effectiveness of these treatments. Therefore, more randomized controlled trials examining the extent of PVTT should be conducted in the future.展开更多
The natural history of Barrett's esophagus (BE) is difficult to quantify because,by definition,it should describe the course of the condition if left untreated.Pragmatically,we assume that patients with BE will re...The natural history of Barrett's esophagus (BE) is difficult to quantify because,by definition,it should describe the course of the condition if left untreated.Pragmatically,we assume that patients with BE will receive symptomatic treatment with acid suppression,usually a proton pump inhibitor,to treat their heartburn.This paper describes the development of complications of stricture,ulcer,dysplasia and adenocarcinoma from this standpoint.Controversies over the definition of BE and its implications in clinical practice are presented.The presence of intestinal metaplasia and its relevance to cancer risk is discussed,and the need to measure the extent of the Barrett's epithelium (long and short segments) using the Prague guidelines is emphasized.Guidelines and international consensus over the diagnosis and management of BE are being regularly updated.The need for expert consensus is important due to the lack of randomized trials in this area.After searching the literature,we have tried to collate the important studies regarding progression of Barrett's to dysplasia and adenocarcinoma.No therapeutic studies yet reported show a clear reduction in the development of cancer in BE.The effect of pharmacological and surgical intervention on the natural history of Barrett's is a subject of ongoing research,including the Barrett's Oesophagus Surveillance Study and the aspirin and esomeprazole cancer chemoprevention trial with interesting results.The geographical variation and the wide range of outcomes highlight the difficulty of providing an individualized risk profile to patients with BE.Future studies on the interaction of genome wide abnormalities in Barrett's and their interaction with environmental factors may allow individualization of the risk of cancer developing in BE.展开更多
Objective: The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients. Methods: ...Objective: The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients. Methods: A randomized single blind trial method was used. Forty-six patients with stage IIIB-IV of HSCLC were randomly divided into experimental group and control group. In the experimental group, the patients were treated with 50 mL Shenfu injection from day 1 to 14, plus vinorelbine (NVB) 25 mg/m^2 on day 1 and 8. In the control group, the patients were only treated with NVB 25 mg/m^2 on day 1 and 8. After two cycle's of treatment, QOL, efficacy and toxicity were observed. Results: The QOL was enhanced in both experimental group and control group. However, the difference of KPS after treatment in the experimental group was markedly higher than in the control group (14 ± 10 vs. 8 ± 10, t = 2.116, P = 0.04), improvement rate of QOL was better than in the control group (76.2% vs. 45.0%, χ^2 = 4.188, P = 0.041), treatment related toxicity in the experimental group was also markedly lower than in the control group (χ^2 = 3.866, P = 0.049), but the difference of efficacy between the two groups was not significant (14.3% vs. 15.0%, χ^2 = 0.161, P = 0.688). Conclusion: Shenfu injection plus vinorelbine can enhance QOL in elderly NSCLC patients.展开更多
Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it deve...Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.展开更多
AIM:To evaluate the effects of soy supplementation on insulin resistance,fatty liver and alanine aminotransferase(ALT) levels in non-diabetic patients with chronic hepatitis C(CHC).METHODS:In a prospective,randomized ...AIM:To evaluate the effects of soy supplementation on insulin resistance,fatty liver and alanine aminotransferase(ALT) levels in non-diabetic patients with chronic hepatitis C(CHC).METHODS:In a prospective,randomized and singleblinded clinical trial,we compared patients with CHC who had casein as a supplement(n = 80)(control group),with patients who consumed a soy supplement diet(n = 80) [intervention group(IG)].Both groups received 32 g/d of protein for 12 wk.RESULTS:Patients' baseline features showed that 48.1% were overweight,43.7% had abdominal fat accumulation,34.7% had hepatic steatosis and 36.3% had an homeostasis model assessment index of insulin resistance(HOMA-IR) ≥ 3.0.Descriptive analysis showed that protein supplementation diet reduced hepatic steatosis in both groups;however,significant reductions in ALT levels occurred in the soy group.Multiple regression modeling indicated that in the presence of severe fibrosis(F3/F4),g glutamyl transferase elevation and high density lipoprotein(HDL) reduction,the intervention group had 75% less chance of developing hepatic steatosis(OR= 0.25;95% CI:0.06-0.82) and 55% less chance of presenting with an ALT level ≥ 1.5 × the upper limit of normal(ULN)(OR = 0.45,95% CI:0.22-0.89).Soy treatment did not have any effect on insulin resistance(OR = 1.92;95% CI:0.80-4.83),which might be attributed to the fact that the HOMAIR values at baseline in most of our patients were in the normal range.Advanced hepatic fibrosis,an ALT level > 1.5 × ULN and visceral fat were predictors of an HOMA-IR ≥ 3.The IG group had a reduced risk of an ALT level > 1.5 × ULN.An HOMA-IR ≥ 3.0 and HDL < 35 mg/dL were also risk factors for increased ALT.CONCLUSION:Soy supplementation decreased ALT levels and thus may improve liver inflammation in hepatitis C virus(HCV) patients;it also reduced hepatic steatosis in a subgroup of patients but did not change insulin resistance.It should be considered in the nutritional care of HCV patients.展开更多
Objective: To evaluate whether herbs of supplementing Qi and nourishing Yin combined with chemotherapy (versus chemotherapy alone) improve survival, increase tumor response, improve performance status or reduce ch...Objective: To evaluate whether herbs of supplementing Qi and nourishing Yin combined with chemotherapy (versus chemotherapy alone) improve survival, increase tumor response, improve performance status or reduce chemotherapy toxicity in patients with lung cancer. Methods: Searching the randomized controlled trials (RCT) studies from the databases (China HowNet database, Wan Fang database, VIP database, Master Thesis and Pubmed) between January 2013 and January 2017. RevMan 5.3 software was used to evaluate the quality of these collected papers. Results: Of 48 potentially relevant publications, 10 randomized studies representing 691 patients met inclusion criteria with 369 cases in the supplementing Qi and nourishing Yin plus Chemotherapy group (Herbs + Chem group) and 322 cases in Chemotherapy group (Chem only group). There were significant differences between Herbs + Chem group and Chem only group in improving the treatment efficacy and reducing the side effects of chemotherapy (P 〈 0.001 for all). There were also significant differences between the two groups in tumor response and quality of life (P 〈 0.001 for all). Conclusion: Herbs of supplementing Qi and nourishing Yin may increase chemotherapy effectiveness, reduce chemotherapy toxicity and improve the quality of life of patients with lung cancer when combined with chemotherapy.展开更多
Objective:The purpose of this study was to assess the curative effect and adverse reaction of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cance...Objective:The purpose of this study was to assess the curative effect and adverse reaction of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cancer(NSCLC).Methods:This prospective randomized controlled trial included 115 patients with locally advanced NSCLC were randomly divided into experimental and control groups and were treated from January 2007 to January 2010.The experimental group of 63 cases was treated with two cycles of induction chemotherapy before operation,radical surgery had been performed about three weeks after completion of chemotherapy,followed by received two cycles of chemotherapy.And the control group(52 cases) was treated at first with radical surgery,then treated with four cycles of chemotherapy.Two groups of the cases received routine thoracic radiotherapy with a total dose of 45 Gy.One cycle of gemcitabine combined with cisplatin regimen included gemcitabine 1000 mg/m2 on day 1 and day 8 and cisplatin 25 mg/m2 on day 1,day 2 and day 3 by intravenous infusion,with 21 days as one cycle.The tumor recurrence was evaluated by chest CT and abdominal B-ultrasound.Efficacy and toxicity results were compared by two groups.Results:All patients were followed up for three months to two years.The surgical stage of the experimental group reduced,two-years disease-free survival and postoperative recovery in the experimental group were better than in the control group,the difference was statistical significant.Toxicity and side effect after chemotherapy were mainly bone marrow suppression and gastrointestinal reactions,other complications included thrombocytopenia,leukopenia,anemia,liver and kidney dysfunction were no significant difference in two groups.Conclusion:Preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced lung cancer can reduce the surgical staging and extend the postoperative disease-free survival.展开更多
There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant b...There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant benefits may be marginal and may not be related to clinical meaningfulness. The typical treatment vs. placebo comparison necessitated by ‘gold standard' randomised controlled trials(RCTs) is not necessarily applicable. The complex multimorbidity of end of life care involves considerations of the patient's physical, psychological, social and spiritual needs. In addition, the field of palliative care covers a heterogeneous group of chronic and incurable diseases no longer limited to cancer. Adequate sample sizes can be difficult to achieve, reducing the power of studies and high attrition rates can result in inadequate follow up periods. This review uses examples of the management of cancer-related fatigue and death rattle(noisy breathing) to demonstrate the current state of EBM in palliative care. The future of EBM in palliative care needs to be as diverse as the patients who ultimately derive benefit. Non-RCT methodologies of equivalent quality, validity and size conducted by collaborative research networks using a ‘mixed methods approach' are likely to pose the correct clinical questions and derive evidencebased yet clinically relevant outcomes.展开更多
Objective:The aim of the study was to investigate the efficacy of three-dimensional conformal radiotherapy (3D-CRT) combined with Temozolomide (TMZ) concurrent chemotherapy in treatment of postoperative cerebral gliom...Objective:The aim of the study was to investigate the efficacy of three-dimensional conformal radiotherapy (3D-CRT) combined with Temozolomide (TMZ) concurrent chemotherapy in treatment of postoperative cerebral gliomas by prospective randomized controlled trials. Methods: Sixty-two patients with cerebral glioma who had residual tumor were divided into 3D-CRT group (radiotherapy group, n=31) and 3D-CRT with concurrent chemotherapy group (chemoradiotherapy group, n=31) prospectively. All patients received a dose of 50-60 Gy/25-30 F/5-6 weeks by 6 MV-X ray, three-dimensional conformal radiotherapy, 1 f/d, 5 times a week. Chemotherapy regimen was Temozolomide:75 mg/m2/d, concomitantly with radiotherapy, followed by 150-200 mg/m2/d, 5 days, 28 days per cycle, totally 3-6 cycles. Results: The total response rate was 35.3% (11/31) in radiotherapy group. The response rate was 61.3% (19/31) in chemoradiotherapy group. There was significant difference in curative effect (P=0.042). There was no significant difference in survival comparison of two groups (P=0.263). Stratified analysis showed the patients with grade Ⅲ gliomas of chemoradiotherapy group had better prognosis than ones of radiotherapy group (P=0.043). Conclusion: The 3D-CRT with concurrent chemotherapy can improve the survival of cerebral gliomas with pathological grade Ⅲ.展开更多
Objective: The aim of this study was to investigate the efficacy of weekly docetaxel (TXT), cisplatin (DDP) combined with continuous infusion of low dose fluorouracil (FU) on advanced gastric carcinoma. Methods...Objective: The aim of this study was to investigate the efficacy of weekly docetaxel (TXT), cisplatin (DDP) combined with continuous infusion of low dose fluorouracil (FU) on advanced gastric carcinoma. Methods: Forty patients with advanced gastric carcinoma were randomly divided into two groups: the research group and the control group with 20 cases in each group. Patients in the research group were given TXT 40 mg/m^2 on dl and d8 plus DDP 30 mg/m^2 on days 1, 3. FU 200 mg/m^2 was infused continually from day 1-14. Patients in control group received ELF regimen therapy. Etoposide (VP- 16) 120 mg/m^2, calcium folinate (CF) 200 mg/m^2, and FU 500 mg/m^2 were given on days 1 and 3. Twenty-eight days were regarded as one cycle. At least two cycles must be completed. The short-term efficacy, adverse reaction, quality of life (QOL), and overall survival (OS) were recorded. Results: The clinical efficacy could be evaluated in 19 patients of research group and 17 patients in control group. The efficacy of research group was significantly better than that in control group (52.63% vs 17.65%, χ^2 = 4.760, P = 0.041). However, the difference was not significant in the frequency of adverse reaction, QOL, median survival time, and OS between the two groups (P 〉 0.05). Conclusion: The short-term efficacy of weekly docetaxel and cisplatin plus low dose FU was better than traditional ELF regimen in the treatment of advanced gastric cancer. It had some value for clinical application.展开更多
Objective The objective of this study was to analyze the status of the clinical application of Yufeng Ningxin(YFNX)preparations and systematically evaluate their efficacy and safety in the treatment of cardiovascular ...Objective The objective of this study was to analyze the status of the clinical application of Yufeng Ningxin(YFNX)preparations and systematically evaluate their efficacy and safety in the treatment of cardiovascular and cerebrovascular diseases.Methods Through searching databases of China National Knowledge Infrastructure,Wanfang,SinoMed,VIP,PubMed,Embase,and the Cochrane Library,the literature of clinical research on YFNX preparations in treating malignant tumors of cardiovascular and cerebrovascular diseases from the establishment of the databases to February 2021 was collected.The clinical randomized controlled trials and case-control studies of cardiovascular and cerebrovascular diseases treated with these preparations were analyzed.Two reviewers independently screened literature,extracted data,and assessed the risk of bias in the included studies,and meta analysis was performed by using ReMan 5.3 software to analyze the eficacy and safety of YFNX preparations in the treatment of cardiovascular and cerebrovascular diseases.Results A total of 29 clinical studies were finally included.The dosage forms were dropping plls,tablets,capsules,and granules.The preparations were used for the treatment of coronary heart disease,hypertension,neuropathic headache,etc.This study systematically evaluated the efficacy and safety of YFNX preparations in the treatment of coronary heart disease,hypertension,and nervous headache.A total of 1,162 cases were included in 13 studies,582 cases of the YFNX preparation group and 580 cases of the Western medicine group.The results of meta-analysis showed that the clinical efficacy of YFNX preparations combined with the Western medicine group in the treatment of coronary heart disease and hypertension,improving electrocardiogram and reducing the frequency and duration of angina attacks,was better than that of the simple Western medicine group,and the difference was statistically significant.Conclusion YFNX preparations are effective for coronary heart disease,hypertension,and neuropathic headache,and the adverse reactions are few.展开更多
The primary aim of clinical trials is to investigate whether a treatment is effective for a particular disease or condition. Randomized controlled clinical trials are considered to be the gold standard for evaluating ...The primary aim of clinical trials is to investigate whether a treatment is effective for a particular disease or condition. Randomized controlled clinical trials are considered to be the gold standard for evaluating the effect of a certain intervention. However, in clinical trials, even after randomization, there are situations where the patients differ substantially with respect to the baseline value of the outcome variable. Many a times the response to interventions depends on the baseline values of the outcome variable. When there are baseline-dependent treatment effects, differences among treatments vary as a function of baseline level. Although variation in outcome associated with baseline value is accounted for in ANCOVA, analysis of individual differences in treatment effect is precluded by the homogeneity of regression assumption. This assumption requires that expected differences in outcome among treatments be constant across all baseline levels. To overcome this difficulty, Weigel and Narvaez [7] proposed a regression model for two treatment groups to analyze individual response to treatments in randomized controlled clinical trials. The authors reviewed the model suggested by Weigel and Narvaez and extended further for three or more treatment groups. The utility of the model was demonstrated with real life data from a randomized controlled clinical trial of bronchial asthma.展开更多
OBJECTIVE Ginsenoside Rg3 (Rg3) has shown anti-tumor effects on various tumor cells. It has been widely used in China for non-small cell lung cancer (NSCLC). However, there are only a few clinical trials to study ...OBJECTIVE Ginsenoside Rg3 (Rg3) has shown anti-tumor effects on various tumor cells. It has been widely used in China for non-small cell lung cancer (NSCLC). However, there are only a few clinical trials to study the effectiveness of Rg3 on NSCLC, and almost them are small- samples, so we performed a meta-analysis on the results of the studies we collected in order to investigate the effectiveness of Rg3 on NSCLC. METHODS A meta-analysis was conducted in all the selected randomized controlled trials evaluating the effectiveness of Rg3 on NSCLC patients. All on-line databases regarding Rg3 from 1950 to 2011 were searched. Supplemental hand searching of the references of retrieved articles was performed. RESULTS Six trials met the inclusion criteria. Four of them compared chemotherapy plus Rg3 with chemotherapy alone, and the other 2 compared chemotherapy plus Rg3 with chemotherapy plus placebo. These trials are homogeneous. Two of the trials report overall survival, but the data are not suitable for a meta-analysis. After meta-analysis was conducted in the included studies comparing the effects of chemotherapy plus Rg3 with that of chemotherapy alone or chemotherapy plus placebo, it was suggested that chemotherapy plus Rg3 increased the response rate [odds ratio: 2.64 (95% Ch 1.70-4.11), fixed effects model] and disease control rate [odds ratio: 3.34 (95% CI: 1.92-5.81); fixed effects model] of the patients at stage II-IV, especially for the patients at stage Ill-IV. CONCLUSION Meta-analysis of the available evidence suggests that Rg3 plus chemotherapy improves the response rate of NSCLC patients, and well-designed RCTs with large sample size are needed.展开更多
This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British ...This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown unknowns.While RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo effects.The recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s mechanisms.This investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community.展开更多
Objective To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in pat...Objective To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in patients with negative symptoms dominated schizophrenia. Methods The trial was a double-blind, placebo-controlled, parallel- group design. The eligible patients were randomized into 2 treatment groups: sarsasapogenin group (sarsasapogenin plus risperidone for 8 weeks, n = 41) and placebo group (risperidone only for 8 weeks, n = 39). At the baseline, as well as at weeks 2, 4 and 8 of treatment, the therapeutic response was measured by using scales including Positive and Nega- tive Symptoms Scale (PANSS), Wechsler Memory Scale (WMS), modified Chinese Wechsler Adult Intelligence Scale (mWAIS), Clinical Global Impression (CGI) and Brief Psychiatry Rating Scale (BPRS). The study period for each subject was 8 weeks and duration of overall trial was 2 years. Results Patients treated with sarsasapogenin plus risperidone demonstrated no statistically significant differences in changes in PANSS, WMS or mWAIS score at the end-point of the trial compared with patients treated with placebo plus risperidone. The incidence of treatment-emergent adverse events in patients treated with sarsasapogenin was not different from that observed in placebo group. Conclusion Sarsasapogenin did not augment the efficacy of risperidone in treating negative symptoms dominated schizophrenia. Sarsasapogenin at a dosage of 200 mg per day added to a flexible dosage of risperidone at 2-4 mg per day is safe and well tolerated by patients with negative symptoms dominated schizophrenia.展开更多
Objective: To analyze and review the clinical efficacy of acupuncture(including electroacupuncture) alone for allergic rhinitis(AR) and to compare its efficacy with antihistamines and Chinese patent medicine Bi Y...Objective: To analyze and review the clinical efficacy of acupuncture(including electroacupuncture) alone for allergic rhinitis(AR) and to compare its efficacy with antihistamines and Chinese patent medicine Bi Yan Kang Tablet. Methods: The search strategy, inclusion and exclusion criteria were made according to the principle of evidence-based medicine. We performed a systematic search on China National Knowledge Infrastructure(CNKI), Wanfang Academic Journal Full-text Database(Wanfang), Chongqing VIP Database(CQVIP), Chinese Biomedical Literature Database(CBM), Pub Med, Excerpta Medica Database(EMBASE), Web of Science, Cochrane Library, and Cochrane Central Register of Controlled Trials(CENTRAL) for randomized controlled trials(RCTs) of acupuncture for allergic rhinitis between January 1990 and December 2015. The quality was evaluated by Cochrane Handbook for Systematic Reviews of Interventions Version 5.1, and the meta-analysis was conducted by Rev Man 5.3 version. Results: Twenty eligible RCTs were included into the meta-analysis after selection. Compared with antihistamines, the meta-analysis showed RR=1.241, 95%CI[1.15, 1.33], P〈0.00001, indicating that acupuncture achieved a better total effective rate for AR than antihistamines; MD=–0.93〈0, 95%CI[–1.22, –0.63], P〈0.00001, indicating that acupuncture is better than antihistamines in decreasing the total nasal symptom score(TNSS) in AR patients; and MD=1.46〉0, 95%CI[–10.84, 13.75], P=0.82, indicating that there was no statistical difference between acupuncture and antihistamines in regulating immunoglobulin E(Ig E) in AR patients. Compared with Bi Yan Kang Tablet, the meta-analysis has shown RR=1.50〉1, 95%CI[1.30, 1.73], P〈0.00001, indicating that acupuncture achieved a better total effective rate for AR than Chinese patent medicine Bi Yan Kang Tablet. Conclusion: Acupuncture alone can achieve a better total effective rate for AR than antihistamines and Bi Yan Kang Tablet. It is also better than antihistamines in improving clinical symptom scores; however, whether acupuncture is better than Bi Yan Kang Tablet needs further proof. As far as current data are concerned, there was no statistical difference between acupuncture and antihistamines in improving serum Ig E; further study is needed in this regard. The risk of bias due to absent randomization methods or blinding implementation decreased the evidence level of the overall conclusion.展开更多
Objective: To observe the efficacy and safety of bloodletting and cupping for cervical radiculopathy. Methods: The randomized controlled clinical trial was conducted in five centers. A total of 183 eligible subjects...Objective: To observe the efficacy and safety of bloodletting and cupping for cervical radiculopathy. Methods: The randomized controlled clinical trial was conducted in five centers. A total of 183 eligible subjects were randomly allocated into a bloodletting group (n=68), an acupuncture group (n=56) and a combined group (n=59). Patients in the bloodletting group were treated with bloodletting at Dazhui (GV 14) and Jianjing (GB 21) on the affected side, coupled with 5-10 min of cupping, 5 mL blood for each cup, 2-3 cups for one treatment. Patients in the acupuncture group were treated with needling cervical Jiaji (EX-B 2) points and Jianjing (GB 21) on the affected side. The needles were retained for 30 min. Patients in the combined group were treated with both methods. The treatment in all three groups were done once every three days, twice a week, 4 weeks for a course of treatment, for a total of 1-3 courses. Then the therapeutic efficacy was evaluated using scores of visual analogue scale (VAS), neck disability index (NDL) and clinical assessment scale (CAS) before treatment and after 1, 2 and 3 courses of treatment. Results: The scores of VAS, NDI and CAS in all three groups were significantly decreased after 1, 2 and 3 courses of treatment (all P〈0.001), and there were no inter-group statistical significances in comparing scores of VAS, NDI and CAS (all P〉0.05). Conclusion: Bloodletting and cupping share the similar effect with acupuncture in pain relief and improvement of quality of life in patients with cervical radiculopathy.展开更多
Objective: To summarize and critically assess the evidence from randomized controlled trials(RCTs) of acupuncture in treating dry eye syndrome(DES) according to the Preferred Reporting Items for Systematic Review...Objective: To summarize and critically assess the evidence from randomized controlled trials(RCTs) of acupuncture in treating dry eye syndrome(DES) according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) statement and the Cochrane Collaboration recommendations.Methods: A search of PubMed, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Embase was made from their inception to August 2016, as well as Chinese, Japanese, and Korean databases. Two reviewers independently selected RCTs and assessed the methodological quality. Meta-analysis and the level of evidence were processed by RevMan 5.3 and the Grading of Recommendations Assessment, Development and Evaluation(GRADE)approach.Results: After selection, 8 trials were subjected to our systematic review. The methodological quality was low generally.The 3-10 weeks follow-up showed that acupuncture improved the tear film break-up time(BUT)(MD=1.33, 95%CI=1.01-1.66, 619 participants). The mean difference of Schirmer's test was 1.73 mm(95%CI=1.28-2.18, 618participants) between the acupuncture group and the control group. The subjective variables exhibited no significant differences.Conclusion: The low methodological quality of the trials does not suggest drawing firm conclusions on the value of acupuncture therapy for DES. Acupuncture treatment may have some effects on the tear film BUT and Schirmer's test,but not on the subjective symptoms. Well-planned large-scale high-quality RCTs are needed to make it clear whether acupuncture is effective in treating DES.展开更多
文摘1 文献来源 Saghir Z, Dirksen A, screening for lung cancer disease. The randomised Ashraf H, et al. CT brings forward early Danish Lung Cancer Screening Trial: Status after five annual screening rounds with low-dose CT[J]. Thorax, 2012,67 (4) : 296-301.
文摘Objective: To assess the role of chemotherapy combined with the compound Chinese herbal medicine,Fuzhenggubenfang (FZGBF), for treating advanced non-small-cell lung cancer. Methods: A total of 84 eligible patientswere enrolled from October 2013 to July 2016. Patients were randomized to receive either chemotherapy alone as thecontrol group or chemotherapy combined with FZGBF as the experimental group. The primary endpoint of the study wasquality of life (QOL) and progression-free survival (PFS). Secondary endpoints were tumor response rate, toxicity,dropout rate, and univariate and multivariate analyses of clinicopathologic factors for QOL and PFS. Results: There wasa significant improvement in QOL, including better overall health (P 〈 0.001), physical function (P 〈 0.001), rolefunction (P 〈 0.001), emotional function (P 〈 0.001), cognitive function (P 〈 0.001), and social function (P = 0.031).Less fatigue, nausea or vomiting, insomnia, appetite loss, constipation, and alopecia were noted (All P 〈 0.001) whenFZGBF was combined with chemotherapy in comparison to chemotherapy alone. The experimental group had a betterPFS compared with the control group (P = 0.032). There was no significant difference in tumor response rate. FZGBFsignificantly reduced chemotherapy-induced anemia (P 〈 0.001), neutropenia (P = 0.023), nausea and vomiting (P 〈0.001). The use of Chinese herbal compounds had only mild side effects. In this study, factors influencing QOL were theuse of the Chinese herbal compounds (P 〈 0.001), performance status score (P = 0.027), clinical staging of cancer (P =0.009), and sex (P = 0.044). Use of traditional Chinese medicine (P = 0.043) and the number of previous chemotherapysessions (P = 0.003) were the factors influencing PFS in this study. Conclusion: FZGBF could improve QOL,compliance to treatment, relieved chemotherapy-related toxicities of patients, and consequently improved PFS, which isa promising drug combination in complementary medicine for the treatment of advanced NSCLC.
基金supported by grants from the Science Fund for Creative Research Groups (Grant No. 81221061)The State Key Project on Diseases of China (Grant No. 2012zx10002016016003)+9 种基金The China National Funds for Distinguished Young Scientists (Grant No. 81125018)Chang Jiang Scholars Program (2013) of Chinese Ministry of EducationThe National Key Basic Research Program (Grant No. 2015CB554000)National Natural Science Foundation of China (Grant No. 81101831, 81101511, and 81472282)The New Excellent Talents Program of Shanghai Municipal Health Bureau (Grant No. XBR2011025)Shanghai Science and Technology Committee (Grant No. 134119a0200)Shanghai Science and Technology Development Funds (Grant No. 14QA1405000)SMMU Innovation Alliance for Liver Cancer Diagnosis and Treatment (Grant 2012)General Program from Shanghai Municipal Health Bureau (Grant No. 20124301)Shanghai Rising-star Program from Shanghai Science and Technology Committee (Grant No.13QA 1404900)
文摘The effect of portal vein tumor thrombus(PVTT) on the prognosis of patients with hepatocellular carcinoma has become clear over the past several decades. However, identifying the mechanisms and performing the diagnosis and treatment of PVTT remain challenging. Therefore, this study aimed to summarize the progress in these areas. A computerized literature search in Medline and EMBASE was performed with the following combinations of search terms: "hepatocellular carcinoma" AND "portal vein tumor thrombus." Although several signal transduction or molecular pathways related to PVTT have been identified, the exact mechanisms of PVTT are still largely unknown. Many biomarkers have been reported to detect microvascular invasion, but none have proved to be clinically useful because of their low accuracy rates. Sorafenib is the only recommended therapeutic strategy in Western countries. However, more treatment options are recommended in Eastern countries, including surgery, radiotherapy(RT), transhepatic arterial chemoembolization(TACE), transarterial radioembolization(TARE), and sorafenib. Therefore, we established a staging system based on the extent of portal vein invasion. Our staging system effectively predicts the long-term survival of PVTT patients. Currently, several clinical trials had shown that surgery is effective and safe in some PVTT patients. RT,TARE, and TACE can also be performed safely in patients with good liver function. However, only a few comparative clinical trials had compared the effectiveness of these treatments. Therefore, more randomized controlled trials examining the extent of PVTT should be conducted in the future.
文摘The natural history of Barrett's esophagus (BE) is difficult to quantify because,by definition,it should describe the course of the condition if left untreated.Pragmatically,we assume that patients with BE will receive symptomatic treatment with acid suppression,usually a proton pump inhibitor,to treat their heartburn.This paper describes the development of complications of stricture,ulcer,dysplasia and adenocarcinoma from this standpoint.Controversies over the definition of BE and its implications in clinical practice are presented.The presence of intestinal metaplasia and its relevance to cancer risk is discussed,and the need to measure the extent of the Barrett's epithelium (long and short segments) using the Prague guidelines is emphasized.Guidelines and international consensus over the diagnosis and management of BE are being regularly updated.The need for expert consensus is important due to the lack of randomized trials in this area.After searching the literature,we have tried to collate the important studies regarding progression of Barrett's to dysplasia and adenocarcinoma.No therapeutic studies yet reported show a clear reduction in the development of cancer in BE.The effect of pharmacological and surgical intervention on the natural history of Barrett's is a subject of ongoing research,including the Barrett's Oesophagus Surveillance Study and the aspirin and esomeprazole cancer chemoprevention trial with interesting results.The geographical variation and the wide range of outcomes highlight the difficulty of providing an individualized risk profile to patients with BE.Future studies on the interaction of genome wide abnormalities in Barrett's and their interaction with environmental factors may allow individualization of the risk of cancer developing in BE.
文摘Objective: The present study aimed to investigate the efficacy of Shenfu injection plus vinorelbine on the promotion of the quality of life (QOL) in elderly non-small cell lung cancer (NSCLC) patients. Methods: A randomized single blind trial method was used. Forty-six patients with stage IIIB-IV of HSCLC were randomly divided into experimental group and control group. In the experimental group, the patients were treated with 50 mL Shenfu injection from day 1 to 14, plus vinorelbine (NVB) 25 mg/m^2 on day 1 and 8. In the control group, the patients were only treated with NVB 25 mg/m^2 on day 1 and 8. After two cycle's of treatment, QOL, efficacy and toxicity were observed. Results: The QOL was enhanced in both experimental group and control group. However, the difference of KPS after treatment in the experimental group was markedly higher than in the control group (14 ± 10 vs. 8 ± 10, t = 2.116, P = 0.04), improvement rate of QOL was better than in the control group (76.2% vs. 45.0%, χ^2 = 4.188, P = 0.041), treatment related toxicity in the experimental group was also markedly lower than in the control group (χ^2 = 3.866, P = 0.049), but the difference of efficacy between the two groups was not significant (14.3% vs. 15.0%, χ^2 = 0.161, P = 0.688). Conclusion: Shenfu injection plus vinorelbine can enhance QOL in elderly NSCLC patients.
文摘Background:The prevalence,morbidity and mortality of chronic obstructive pulmonary disease(COPD)is very high,so it has become a public health problem.The early stage of COPD has been paid much attention before it develops severely.As well,traditional Chinese medicine has some advantages in relieving symptoms and reducing the incidence of COPD exacerbations.Methods:A practical randomized controlled trial will be designed to test the clinical effects of traditional Chinese medicine treatment according to syndrome differentiation.A total of 80 patients with mild/moderate COPD will participate in this study,40 in the treatment group and 40 in the control group.On the basis of the lifestyle intervention,traditional Chinese medicine formula granules for treatment group and the placebo simulation of traditional Chinese medicine granules for control group.The exacerbation and the improvement of pulmonary function will be used as the primary outcome measures.The improvement of clinical symptoms and signs,the quality of life and Dyspnea will be used as the secondary outcomes measures.Conclusion:We assume that the COPD patients will be benefit from therapy with Traditional Chinese medicine treatment.
基金Supported by Gold Nutrition Indústria e Comercio and Centro colaborador Nordeste II/Ministério da Saúde,Brazil
文摘AIM:To evaluate the effects of soy supplementation on insulin resistance,fatty liver and alanine aminotransferase(ALT) levels in non-diabetic patients with chronic hepatitis C(CHC).METHODS:In a prospective,randomized and singleblinded clinical trial,we compared patients with CHC who had casein as a supplement(n = 80)(control group),with patients who consumed a soy supplement diet(n = 80) [intervention group(IG)].Both groups received 32 g/d of protein for 12 wk.RESULTS:Patients' baseline features showed that 48.1% were overweight,43.7% had abdominal fat accumulation,34.7% had hepatic steatosis and 36.3% had an homeostasis model assessment index of insulin resistance(HOMA-IR) ≥ 3.0.Descriptive analysis showed that protein supplementation diet reduced hepatic steatosis in both groups;however,significant reductions in ALT levels occurred in the soy group.Multiple regression modeling indicated that in the presence of severe fibrosis(F3/F4),g glutamyl transferase elevation and high density lipoprotein(HDL) reduction,the intervention group had 75% less chance of developing hepatic steatosis(OR= 0.25;95% CI:0.06-0.82) and 55% less chance of presenting with an ALT level ≥ 1.5 × the upper limit of normal(ULN)(OR = 0.45,95% CI:0.22-0.89).Soy treatment did not have any effect on insulin resistance(OR = 1.92;95% CI:0.80-4.83),which might be attributed to the fact that the HOMAIR values at baseline in most of our patients were in the normal range.Advanced hepatic fibrosis,an ALT level > 1.5 × ULN and visceral fat were predictors of an HOMA-IR ≥ 3.The IG group had a reduced risk of an ALT level > 1.5 × ULN.An HOMA-IR ≥ 3.0 and HDL < 35 mg/dL were also risk factors for increased ALT.CONCLUSION:Soy supplementation decreased ALT levels and thus may improve liver inflammation in hepatitis C virus(HCV) patients;it also reduced hepatic steatosis in a subgroup of patients but did not change insulin resistance.It should be considered in the nutritional care of HCV patients.
文摘Objective: To evaluate whether herbs of supplementing Qi and nourishing Yin combined with chemotherapy (versus chemotherapy alone) improve survival, increase tumor response, improve performance status or reduce chemotherapy toxicity in patients with lung cancer. Methods: Searching the randomized controlled trials (RCT) studies from the databases (China HowNet database, Wan Fang database, VIP database, Master Thesis and Pubmed) between January 2013 and January 2017. RevMan 5.3 software was used to evaluate the quality of these collected papers. Results: Of 48 potentially relevant publications, 10 randomized studies representing 691 patients met inclusion criteria with 369 cases in the supplementing Qi and nourishing Yin plus Chemotherapy group (Herbs + Chem group) and 322 cases in Chemotherapy group (Chem only group). There were significant differences between Herbs + Chem group and Chem only group in improving the treatment efficacy and reducing the side effects of chemotherapy (P 〈 0.001 for all). There were also significant differences between the two groups in tumor response and quality of life (P 〈 0.001 for all). Conclusion: Herbs of supplementing Qi and nourishing Yin may increase chemotherapy effectiveness, reduce chemotherapy toxicity and improve the quality of life of patients with lung cancer when combined with chemotherapy.
基金Supported by a grant from the Research Foundation of Education Bureau of Hubei Province,China (No. B20112116)
文摘Objective:The purpose of this study was to assess the curative effect and adverse reaction of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cancer(NSCLC).Methods:This prospective randomized controlled trial included 115 patients with locally advanced NSCLC were randomly divided into experimental and control groups and were treated from January 2007 to January 2010.The experimental group of 63 cases was treated with two cycles of induction chemotherapy before operation,radical surgery had been performed about three weeks after completion of chemotherapy,followed by received two cycles of chemotherapy.And the control group(52 cases) was treated at first with radical surgery,then treated with four cycles of chemotherapy.Two groups of the cases received routine thoracic radiotherapy with a total dose of 45 Gy.One cycle of gemcitabine combined with cisplatin regimen included gemcitabine 1000 mg/m2 on day 1 and day 8 and cisplatin 25 mg/m2 on day 1,day 2 and day 3 by intravenous infusion,with 21 days as one cycle.The tumor recurrence was evaluated by chest CT and abdominal B-ultrasound.Efficacy and toxicity results were compared by two groups.Results:All patients were followed up for three months to two years.The surgical stage of the experimental group reduced,two-years disease-free survival and postoperative recovery in the experimental group were better than in the control group,the difference was statistical significant.Toxicity and side effect after chemotherapy were mainly bone marrow suppression and gastrointestinal reactions,other complications included thrombocytopenia,leukopenia,anemia,liver and kidney dysfunction were no significant difference in two groups.Conclusion:Preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced lung cancer can reduce the surgical staging and extend the postoperative disease-free survival.
文摘There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant benefits may be marginal and may not be related to clinical meaningfulness. The typical treatment vs. placebo comparison necessitated by ‘gold standard' randomised controlled trials(RCTs) is not necessarily applicable. The complex multimorbidity of end of life care involves considerations of the patient's physical, psychological, social and spiritual needs. In addition, the field of palliative care covers a heterogeneous group of chronic and incurable diseases no longer limited to cancer. Adequate sample sizes can be difficult to achieve, reducing the power of studies and high attrition rates can result in inadequate follow up periods. This review uses examples of the management of cancer-related fatigue and death rattle(noisy breathing) to demonstrate the current state of EBM in palliative care. The future of EBM in palliative care needs to be as diverse as the patients who ultimately derive benefit. Non-RCT methodologies of equivalent quality, validity and size conducted by collaborative research networks using a ‘mixed methods approach' are likely to pose the correct clinical questions and derive evidencebased yet clinically relevant outcomes.
文摘Objective:The aim of the study was to investigate the efficacy of three-dimensional conformal radiotherapy (3D-CRT) combined with Temozolomide (TMZ) concurrent chemotherapy in treatment of postoperative cerebral gliomas by prospective randomized controlled trials. Methods: Sixty-two patients with cerebral glioma who had residual tumor were divided into 3D-CRT group (radiotherapy group, n=31) and 3D-CRT with concurrent chemotherapy group (chemoradiotherapy group, n=31) prospectively. All patients received a dose of 50-60 Gy/25-30 F/5-6 weeks by 6 MV-X ray, three-dimensional conformal radiotherapy, 1 f/d, 5 times a week. Chemotherapy regimen was Temozolomide:75 mg/m2/d, concomitantly with radiotherapy, followed by 150-200 mg/m2/d, 5 days, 28 days per cycle, totally 3-6 cycles. Results: The total response rate was 35.3% (11/31) in radiotherapy group. The response rate was 61.3% (19/31) in chemoradiotherapy group. There was significant difference in curative effect (P=0.042). There was no significant difference in survival comparison of two groups (P=0.263). Stratified analysis showed the patients with grade Ⅲ gliomas of chemoradiotherapy group had better prognosis than ones of radiotherapy group (P=0.043). Conclusion: The 3D-CRT with concurrent chemotherapy can improve the survival of cerebral gliomas with pathological grade Ⅲ.
文摘Objective: The aim of this study was to investigate the efficacy of weekly docetaxel (TXT), cisplatin (DDP) combined with continuous infusion of low dose fluorouracil (FU) on advanced gastric carcinoma. Methods: Forty patients with advanced gastric carcinoma were randomly divided into two groups: the research group and the control group with 20 cases in each group. Patients in the research group were given TXT 40 mg/m^2 on dl and d8 plus DDP 30 mg/m^2 on days 1, 3. FU 200 mg/m^2 was infused continually from day 1-14. Patients in control group received ELF regimen therapy. Etoposide (VP- 16) 120 mg/m^2, calcium folinate (CF) 200 mg/m^2, and FU 500 mg/m^2 were given on days 1 and 3. Twenty-eight days were regarded as one cycle. At least two cycles must be completed. The short-term efficacy, adverse reaction, quality of life (QOL), and overall survival (OS) were recorded. Results: The clinical efficacy could be evaluated in 19 patients of research group and 17 patients in control group. The efficacy of research group was significantly better than that in control group (52.63% vs 17.65%, χ^2 = 4.760, P = 0.041). However, the difference was not significant in the frequency of adverse reaction, QOL, median survival time, and OS between the two groups (P 〉 0.05). Conclusion: The short-term efficacy of weekly docetaxel and cisplatin plus low dose FU was better than traditional ELF regimen in the treatment of advanced gastric cancer. It had some value for clinical application.
基金supported by Tianjin Municipal Education Commission Scientifc Research Program(2021KJ170).
文摘Objective The objective of this study was to analyze the status of the clinical application of Yufeng Ningxin(YFNX)preparations and systematically evaluate their efficacy and safety in the treatment of cardiovascular and cerebrovascular diseases.Methods Through searching databases of China National Knowledge Infrastructure,Wanfang,SinoMed,VIP,PubMed,Embase,and the Cochrane Library,the literature of clinical research on YFNX preparations in treating malignant tumors of cardiovascular and cerebrovascular diseases from the establishment of the databases to February 2021 was collected.The clinical randomized controlled trials and case-control studies of cardiovascular and cerebrovascular diseases treated with these preparations were analyzed.Two reviewers independently screened literature,extracted data,and assessed the risk of bias in the included studies,and meta analysis was performed by using ReMan 5.3 software to analyze the eficacy and safety of YFNX preparations in the treatment of cardiovascular and cerebrovascular diseases.Results A total of 29 clinical studies were finally included.The dosage forms were dropping plls,tablets,capsules,and granules.The preparations were used for the treatment of coronary heart disease,hypertension,neuropathic headache,etc.This study systematically evaluated the efficacy and safety of YFNX preparations in the treatment of coronary heart disease,hypertension,and nervous headache.A total of 1,162 cases were included in 13 studies,582 cases of the YFNX preparation group and 580 cases of the Western medicine group.The results of meta-analysis showed that the clinical efficacy of YFNX preparations combined with the Western medicine group in the treatment of coronary heart disease and hypertension,improving electrocardiogram and reducing the frequency and duration of angina attacks,was better than that of the simple Western medicine group,and the difference was statistically significant.Conclusion YFNX preparations are effective for coronary heart disease,hypertension,and neuropathic headache,and the adverse reactions are few.
文摘The primary aim of clinical trials is to investigate whether a treatment is effective for a particular disease or condition. Randomized controlled clinical trials are considered to be the gold standard for evaluating the effect of a certain intervention. However, in clinical trials, even after randomization, there are situations where the patients differ substantially with respect to the baseline value of the outcome variable. Many a times the response to interventions depends on the baseline values of the outcome variable. When there are baseline-dependent treatment effects, differences among treatments vary as a function of baseline level. Although variation in outcome associated with baseline value is accounted for in ANCOVA, analysis of individual differences in treatment effect is precluded by the homogeneity of regression assumption. This assumption requires that expected differences in outcome among treatments be constant across all baseline levels. To overcome this difficulty, Weigel and Narvaez [7] proposed a regression model for two treatment groups to analyze individual response to treatments in randomized controlled clinical trials. The authors reviewed the model suggested by Weigel and Narvaez and extended further for three or more treatment groups. The utility of the model was demonstrated with real life data from a randomized controlled clinical trial of bronchial asthma.
文摘OBJECTIVE Ginsenoside Rg3 (Rg3) has shown anti-tumor effects on various tumor cells. It has been widely used in China for non-small cell lung cancer (NSCLC). However, there are only a few clinical trials to study the effectiveness of Rg3 on NSCLC, and almost them are small- samples, so we performed a meta-analysis on the results of the studies we collected in order to investigate the effectiveness of Rg3 on NSCLC. METHODS A meta-analysis was conducted in all the selected randomized controlled trials evaluating the effectiveness of Rg3 on NSCLC patients. All on-line databases regarding Rg3 from 1950 to 2011 were searched. Supplemental hand searching of the references of retrieved articles was performed. RESULTS Six trials met the inclusion criteria. Four of them compared chemotherapy plus Rg3 with chemotherapy alone, and the other 2 compared chemotherapy plus Rg3 with chemotherapy plus placebo. These trials are homogeneous. Two of the trials report overall survival, but the data are not suitable for a meta-analysis. After meta-analysis was conducted in the included studies comparing the effects of chemotherapy plus Rg3 with that of chemotherapy alone or chemotherapy plus placebo, it was suggested that chemotherapy plus Rg3 increased the response rate [odds ratio: 2.64 (95% Ch 1.70-4.11), fixed effects model] and disease control rate [odds ratio: 3.34 (95% CI: 1.92-5.81); fixed effects model] of the patients at stage II-IV, especially for the patients at stage Ill-IV. CONCLUSION Meta-analysis of the available evidence suggests that Rg3 plus chemotherapy improves the response rate of NSCLC patients, and well-designed RCTs with large sample size are needed.
文摘This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown unknowns.While RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo effects.The recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s mechanisms.This investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community.
基金supported by thegrant of Stanley Medical Research Institute(No.02I-005),USA
文摘Objective To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in patients with negative symptoms dominated schizophrenia. Methods The trial was a double-blind, placebo-controlled, parallel- group design. The eligible patients were randomized into 2 treatment groups: sarsasapogenin group (sarsasapogenin plus risperidone for 8 weeks, n = 41) and placebo group (risperidone only for 8 weeks, n = 39). At the baseline, as well as at weeks 2, 4 and 8 of treatment, the therapeutic response was measured by using scales including Positive and Nega- tive Symptoms Scale (PANSS), Wechsler Memory Scale (WMS), modified Chinese Wechsler Adult Intelligence Scale (mWAIS), Clinical Global Impression (CGI) and Brief Psychiatry Rating Scale (BPRS). The study period for each subject was 8 weeks and duration of overall trial was 2 years. Results Patients treated with sarsasapogenin plus risperidone demonstrated no statistically significant differences in changes in PANSS, WMS or mWAIS score at the end-point of the trial compared with patients treated with placebo plus risperidone. The incidence of treatment-emergent adverse events in patients treated with sarsasapogenin was not different from that observed in placebo group. Conclusion Sarsasapogenin did not augment the efficacy of risperidone in treating negative symptoms dominated schizophrenia. Sarsasapogenin at a dosage of 200 mg per day added to a flexible dosage of risperidone at 2-4 mg per day is safe and well tolerated by patients with negative symptoms dominated schizophrenia.
基金supported by Youth Research Project of Shanghai Municipal Health and Family Planning Commission(No.20124Y009,No.20134Y148)Shanghai Municipal Health and Family Planning Commission Research Project(No.201540150)~~
文摘Objective: To analyze and review the clinical efficacy of acupuncture(including electroacupuncture) alone for allergic rhinitis(AR) and to compare its efficacy with antihistamines and Chinese patent medicine Bi Yan Kang Tablet. Methods: The search strategy, inclusion and exclusion criteria were made according to the principle of evidence-based medicine. We performed a systematic search on China National Knowledge Infrastructure(CNKI), Wanfang Academic Journal Full-text Database(Wanfang), Chongqing VIP Database(CQVIP), Chinese Biomedical Literature Database(CBM), Pub Med, Excerpta Medica Database(EMBASE), Web of Science, Cochrane Library, and Cochrane Central Register of Controlled Trials(CENTRAL) for randomized controlled trials(RCTs) of acupuncture for allergic rhinitis between January 1990 and December 2015. The quality was evaluated by Cochrane Handbook for Systematic Reviews of Interventions Version 5.1, and the meta-analysis was conducted by Rev Man 5.3 version. Results: Twenty eligible RCTs were included into the meta-analysis after selection. Compared with antihistamines, the meta-analysis showed RR=1.241, 95%CI[1.15, 1.33], P〈0.00001, indicating that acupuncture achieved a better total effective rate for AR than antihistamines; MD=–0.93〈0, 95%CI[–1.22, –0.63], P〈0.00001, indicating that acupuncture is better than antihistamines in decreasing the total nasal symptom score(TNSS) in AR patients; and MD=1.46〉0, 95%CI[–10.84, 13.75], P=0.82, indicating that there was no statistical difference between acupuncture and antihistamines in regulating immunoglobulin E(Ig E) in AR patients. Compared with Bi Yan Kang Tablet, the meta-analysis has shown RR=1.50〉1, 95%CI[1.30, 1.73], P〈0.00001, indicating that acupuncture achieved a better total effective rate for AR than Chinese patent medicine Bi Yan Kang Tablet. Conclusion: Acupuncture alone can achieve a better total effective rate for AR than antihistamines and Bi Yan Kang Tablet. It is also better than antihistamines in improving clinical symptom scores; however, whether acupuncture is better than Bi Yan Kang Tablet needs further proof. As far as current data are concerned, there was no statistical difference between acupuncture and antihistamines in improving serum Ig E; further study is needed in this regard. The risk of bias due to absent randomization methods or blinding implementation decreased the evidence level of the overall conclusion.
基金supported by Scientific Research Project of Integrative Chinese and Western Medicine by Tianjin Municipal Health BureauNo.11027~~
文摘Objective: To observe the efficacy and safety of bloodletting and cupping for cervical radiculopathy. Methods: The randomized controlled clinical trial was conducted in five centers. A total of 183 eligible subjects were randomly allocated into a bloodletting group (n=68), an acupuncture group (n=56) and a combined group (n=59). Patients in the bloodletting group were treated with bloodletting at Dazhui (GV 14) and Jianjing (GB 21) on the affected side, coupled with 5-10 min of cupping, 5 mL blood for each cup, 2-3 cups for one treatment. Patients in the acupuncture group were treated with needling cervical Jiaji (EX-B 2) points and Jianjing (GB 21) on the affected side. The needles were retained for 30 min. Patients in the combined group were treated with both methods. The treatment in all three groups were done once every three days, twice a week, 4 weeks for a course of treatment, for a total of 1-3 courses. Then the therapeutic efficacy was evaluated using scores of visual analogue scale (VAS), neck disability index (NDL) and clinical assessment scale (CAS) before treatment and after 1, 2 and 3 courses of treatment. Results: The scores of VAS, NDI and CAS in all three groups were significantly decreased after 1, 2 and 3 courses of treatment (all P〈0.001), and there were no inter-group statistical significances in comparing scores of VAS, NDI and CAS (all P〉0.05). Conclusion: Bloodletting and cupping share the similar effect with acupuncture in pain relief and improvement of quality of life in patients with cervical radiculopathy.
基金supported by Scientific Research Projects of Shanghai Municipal Science and Technology Commission,No.11140900902,No.14401971600,No.14401933100the Third Batch of Competitive Clinical Project of Traditional Chinese Medicine in Shanghai,No.ZYSNXD-YL-YSZK015Shanghai Three-year Action Plan of Traditional Chinese Medicine,No.CC-3-3051~~
文摘Objective: To summarize and critically assess the evidence from randomized controlled trials(RCTs) of acupuncture in treating dry eye syndrome(DES) according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA) statement and the Cochrane Collaboration recommendations.Methods: A search of PubMed, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Embase was made from their inception to August 2016, as well as Chinese, Japanese, and Korean databases. Two reviewers independently selected RCTs and assessed the methodological quality. Meta-analysis and the level of evidence were processed by RevMan 5.3 and the Grading of Recommendations Assessment, Development and Evaluation(GRADE)approach.Results: After selection, 8 trials were subjected to our systematic review. The methodological quality was low generally.The 3-10 weeks follow-up showed that acupuncture improved the tear film break-up time(BUT)(MD=1.33, 95%CI=1.01-1.66, 619 participants). The mean difference of Schirmer's test was 1.73 mm(95%CI=1.28-2.18, 618participants) between the acupuncture group and the control group. The subjective variables exhibited no significant differences.Conclusion: The low methodological quality of the trials does not suggest drawing firm conclusions on the value of acupuncture therapy for DES. Acupuncture treatment may have some effects on the tear film BUT and Schirmer's test,but not on the subjective symptoms. Well-planned large-scale high-quality RCTs are needed to make it clear whether acupuncture is effective in treating DES.