OBJECTIVE:To observe the therapeutic effect of lumbar tender point deep tissue massage plus lumbar traction on chronic non-specific low back pain using change in pressure pain threshold,muscle hardness and pain intens...OBJECTIVE:To observe the therapeutic effect of lumbar tender point deep tissue massage plus lumbar traction on chronic non-specific low back pain using change in pressure pain threshold,muscle hardness and pain intensity as indices.METHODS:We randomly divided 64 patients into a treatment group(32 cases) and a control group(32 cases).Two drop-outs occurred in each group.Patients in the treatment group received tender point deep tissue massage plus lumbar traction and patients in the control group received lumbar traction,alone.We used a tissue hardness meter/algometer and visual analog scale(VAS) to assess the pressure pain threshold,muscle hardness and pain intensity.RESULTS:Following treatment,we obtained the following results in the treatment and control groups,respectively:the pressure pain threshold difference was 1.5±0.8 and 1.1±0.7;the muscle hardness difference was 4.2±1.6 and 3.5±1.3;and the VAS score difference was 1.9±0.9 and 1.4±0.8.Compared to the control group,the treatment group had higher pressure pain threshold(t=2.09,P<0.05),and lower muscle hardness(t=2.05,P<0.05) and pain intensity(t=2.46,P<0.05).CONCLUSION:Lumbar tender point deep tissue massage combined with lumbar traction produced better improvement in pressure pain threshold,muscle hardness and pain intensity in patients with chronic non-specific low back pain than with lumbar traction alone.展开更多
It is a common view that the integration of Chinese medicine (CM) and modern Western medicine is an efficient way to facilitate the development of CM. Integrative medicine is a kind of complex interventions. Scienti...It is a common view that the integration of Chinese medicine (CM) and modern Western medicine is an efficient way to facilitate the development of CM. Integrative medicine is a kind of complex interventions. Scientific therapeutic evaluation plays a crucial role in making integrative medicine universally acknowledged. However, the modern method of clinical study, which is based on the concept of evidence-based medicine, mostly focuses on the population characteristics and single interventional factor. As a result, it is difficult for this method to totally adapt to the clinical features of CM and integrative medicine as complex interventions. One possible way to solve this issue is to improve and integrate with the existing method and to utilize the evaluation model on complex interventions from abroad. As an interdisciplinary technique, data mining involves database technology, artificial intelligence, machine learning, statistics, neural network and some other latest technologies, and has been widely used in the field of CM. Therefore, the application of data mining in the therapeutic evaluation of integrative medicine has broad prospects.展开更多
To probe the significance of specific IgG4 in sera of patients with cerebral cys ticercosis for diagnosis and therapeutic evaluation Methods Specific IgG4 in sera of patients with cerebral cysticercosis was assessed...To probe the significance of specific IgG4 in sera of patients with cerebral cys ticercosis for diagnosis and therapeutic evaluation Methods Specific IgG4 in sera of patients with cerebral cysticercosis was assessed using colloidal gold labeled mouse anti human IgG4 McAb as probe The results wer e compared with the CT image manifestation Results The specific IgG4 positive rate in sera of patients with cerebral cysticercosis was 97 8%, whereas sera from patients with other kinds of parasitosis or centra l nerve system disease and the control group were all negative, except for a wea k cross reaction of sera from patients with hepatic echinococoosis The determ ination of specific IgG4 in sera of patients with cerebral cysticercosis during different times of treatment showed that along with an increase in treatment tim e and improvement of clinical symptoms, specific IgG4 level gradually decreased The positive rate and intensity of specific IgG4 in sera from patients with c erebral cysticercosis were consistent with the number of cysticercus parasites i n the brain and pathologic changes, such as survival, disintegration, death and calcification Survival of cysticercus in the brain was ABSTRACTly evaluated u sing this technique Conclusions The determination of specific IgG4 in sera is a practical method for diagnosis a nd therapeutic evaluation of cerebral cysticercosis展开更多
Spinal muscular atrophy is a devastating motor neuron disease characterized by severe cases of fatal muscle weakness.It is one of the most common genetic causes of mortality among infants aged less than 2 years.Biomar...Spinal muscular atrophy is a devastating motor neuron disease characterized by severe cases of fatal muscle weakness.It is one of the most common genetic causes of mortality among infants aged less than 2 years.Biomarker research is currently receiving more attention,and new candidate biomarkers are constantly being discovered.This review initially discusses the evaluation methods commonly used in clinical practice while briefly outlining their respective pros and cons.We also describe recent advancements in research and the clinical significance of molecular biomarkers for spinal muscular atrophy,which are classified as either specific or non-specific biomarkers.This review provides new insights into the pathogenesis of spinal muscular atrophy,the mechanism of biomarkers in response to drug-modified therapies,the selection of biomarker candidates,and would promote the development of future research.Furthermore,the successful utilization of biomarkers may facilitate the implementation of gene-targeting treatments for patients with spinal muscular atrophy.展开更多
This study aimed to develop a guideline for therapeutic drug monitoring(TDM) of vancomycin. We adopted the new guideline definition from the Institute of Medicine(IOM), adhered closely to the six domains of the Ap...This study aimed to develop a guideline for therapeutic drug monitoring(TDM) of vancomycin. We adopted the new guideline definition from the Institute of Medicine(IOM), adhered closely to the six domains of the Appraisal of Guidelines for Research & Evaluation Ⅱ(AGREE Ⅱ), and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome(PICO) and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation(GRADE).展开更多
Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record ...Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record following the concept of narrative evidence-based medicine.Methods:The information was searched from Pubmed,Embase,CBMdisc,CNKI.A preliminary agreement was reached by referring to the principles of narrative medicine and advises given by experts of digestive system and evidence-based medicine in both Traditional Chinese Medicine and Western Medicine.Result:This research is a useful attempt to discuss the establishment of doctor-patient co-operated evidence-based medical record guided by the direction of narrative evidence-based medicine.Reflection and outlook:Doctor-patient co-operated medical record can be a key factor of the curative effect evaluation methodology system of integrated therapy of Tradition Chinese Medicine and Western Medicine on spleen and stomach diseases.展开更多
Objective: To evaluate the efficacy of double-phase contrast material-enhanced computed tomography (CT) in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily. Methods: 52 patients wit...Objective: To evaluate the efficacy of double-phase contrast material-enhanced computed tomography (CT) in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily. Methods: 52 patients with bronchogenic carcinoma after no-surgical treatment underwent double-phase contrast material-enhanced computed tomography. Two spiral CT scans were obtained at 25 and 90 seconds respectively after nonionic contrast material was administrated via the antecubital vein at a rate of 4 mUs by using an autoinjector. Precontrast and postcontrast attenuation on every scan was recorded and peak height was calculated. Enhancement pattern was evaluated on the images obtained at 25 and 90 seconds after injection of contrast medium. Results: Precontrast attenuation, postcontrast attenuation at 25 and 90 seconds were 42.20 ± 7.43 Hu, 57.35 ± 10.09 Hu and 71.85 ±12.45 Hu, respectively. No statistically significant difference in precontrast attenuation was found between our results in the study and the results in our old study (mean precontrast attenuation 40.70 Hu) which was obtained in cases before therapy (t = 1.455, P = 0.152 〉 0.05). Peak height of bronchogenic carcinoma after no-surgical treatment (29.46 ±10.85 Hu) were significantly lower than that of bronchogenic carcinoma before therapy obtained in our old study (mean peak height 35.79 Hu; t = 4.206, P = 0.001 〈 0.05). 32 of 52 cases showed homogeneous enhancement at 90 seconds. Of the 32 cases, there were 21 with inhomogeneous enhancement, 7 with inhomogeneous enhancement, 2 with central enhancement and 2 with peripheral enhancement at 25 seconds. Conclusion: Bronchogenic carcinoma after no-surgical treatment shows a gradual increase to the peak height after administration of contrast material. Peak heights can reflect the blood supply of bronchogenic carcinoma and might be index for evaluation of no-surgical treatment response in bronchogenic carcinoma.展开更多
Objective: To observe the clinical efficacy of Penyanqing Capsule (盆炎清胶囊, PYQC) in treating pelvic inflammation of Qi-stagnation with blood stasis syndrome. Methods: The randomized, single blinded, parallel p...Objective: To observe the clinical efficacy of Penyanqing Capsule (盆炎清胶囊, PYQC) in treating pelvic inflammation of Qi-stagnation with blood stasis syndrome. Methods: The randomized, single blinded, parallel positive drug controlled method was adopted, with 82 patients assigned into two groups by envelop method. The 42 patients in the treated group received PYQC 3 times a day, 4 capsules each time taken orally; the 40 patients in the control group were given orally Fuyankang tablets (妇炎康片, FYKT) 3 times a day, 6 tablets each time. The therapeutic course for both groups was 2 months, and 2 courses of treatment were given successively to observe the comprehensive effect, changes of symptoms and signs before and after treatment. The effects of PYQC on hemorrheological character in part of the patients and on the pathogenetic chlamydia and mycoplasma were also observed. Results: The total effective rate in the treated group was 83.3%, which was insignificantly different from that in the control group (77.5%, P〉0.05). However, PYQC could significantly lower the hemorrheologic indexes in patients and showed definite influence on the pathogenetic chlamydia and mycoplasma. Conclusion: PYQC has good therapeutic effect in treating chronic pelvic inflammation of Qi-stagnation with blood stasis syndrome, and showed definite effect on chlamydia and mycoplasma.展开更多
The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential...The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.展开更多
An optimal therapy for pulmonary embolism(PE) was explored by comparing three different methods in order to alleviate the sufferings of PE patients and reduce the mortality. Eighty patients with PE diagnosed by comp...An optimal therapy for pulmonary embolism(PE) was explored by comparing three different methods in order to alleviate the sufferings of PE patients and reduce the mortality. Eighty patients with PE diagnosed by computed tomography angiography(CTA) were treated with thrombolysis, anticoagulation only, or surgery/intervention. The clinical efficacy of different treatments were compared and analyzed. Twenty-four out of the 26 patients(92%) in anticoagulation only group showed improvement in CTA and clinical presentations, which was significantly higher than that in the thrombolysis group(87%, n=39, P〈0.05). However, there was no significant difference in the rate of mortality between thrombolysis group and anticoagulation only group. In the surgery/interventional group(n=15), the success rate was 47%, and the mortality rate was 14%. Both of them were significantly different from those in thrombolysis and anticoagulation only groups(both P〈0.05). Log-rank analysis of the data of 5-year follow-up revealed that the survival time in surgery/intervention group was significantly shorter than in the other two groups(P0.05). It was suggested that it is of importance to choose the appropriate therapeutic regimen for PE patients. Mortality may be reduced and prognosis may be improved with anticoagulation only and thrombolysis therapy.展开更多
Objective: The aim of this study was to evaluate the efficacy of changes in enhancement pattern in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily. Methods Thirty-three patients with ...Objective: The aim of this study was to evaluate the efficacy of changes in enhancement pattern in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily. Methods Thirty-three patients with bronchogenic carcinoma underwent two-phase contrast material-enhanced computed tomography prior to and after stopping no-surgical treatment more than one-month respectively. Two spiral CT scans were obtained at 25 and 90 s respectively after nonionic contrast material was administrated via the antecubital vein at a rate of 3 mL/s by using an autoinjector. The sum of the tumor longest diameters (LD) prior to treatment, after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 s after injection of contrast medium were recorded, Precontrast and postcontrast attenuation on every scan was recorded and peak height was calculated. The significance of the difference among groups was analyzed by means of ANOVA, student t test and chi-square test. Results: The sum of the tumor LD prior to treatment, that of after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 s after injection of contrast medium were (4.49 ± 1.32), (4.05 ± 1.63), (3.36 ± 1.22) cm respectively and there were statistically significant dif- ferences among them (f= 5.467, P = 0.006). The sum of the tumor LD prior to treatment was significantly higher than that of the post-treatment tumor enhancement area (P = 0.001). No statistically significant difference in the sum of the tumor LD was found between the pre- treatment and the post-treatment (P = 0.207). There was no statistically significant difference between the sum of the tumors LD and that of tumor enhancement area after treatment (P = 0.086). The response rate (RR) (21.21%) according to changes in sum of the tumor LD was significantly lower than that (30.30%) according to changes in the sum of the post-treatment tumor enhancement area LD (x2 = 15.12, P 〈 0.05), and the progressive diseases (PD) rate (21.21%) was significantly higher than that (12.12%; X2 = 14.12, P 〈 0.05). No statistically significant difference was found between precontrast attenuation prior to treatment [(41.77±7.03) HU] and that after treatment [(41.89 ± 7.63) HU; t = 0.335, P = 0.740 〉 0.05]. Peak height of bronchogenic carcinoma prior to treatment [(36.50 ± 11.21) HU] were significantly higher than that after treatment [(29.91 ± 10.35) HU; t = 10.081, P = 0.001]. Conclusion: Therapeutic effect may be underestimated with use of changes in sum of the tumor LD. The changes in sum of tumor enhancement area LD in addition to peak height is suggested to be used in assessing no-surgical.treatment response in bronchogenic carcinoma.展开更多
Objective:The aim of this study was to evaluate the efficacy of changes in the sum of the enhancement area longest diameters(LD) in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily.Meth...Objective:The aim of this study was to evaluate the efficacy of changes in the sum of the enhancement area longest diameters(LD) in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily.Methods:Twentytwo patients with bronchogenic carcinoma underwent two-phase contrast material-enhanced computed tomography prior to and after stopping no-surgical treatment more than one-month respectively.Two spiral CT scans were obtained at 25 and 90 sec respectively after nonionic contrast material was administrated via the antecubital vein at a rate of 3 mL/sec by using an autoinjector.The sum of the tumor LD prior to treatment,after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 sec after injection of contrast medium were recorded.Enhancement pattern was evaluated on the images obtained at 25 and 90 sec after injection of contrast medium.Response Evaluation Criteria In Solid Tumors(RECIST) guidelines were adopted to evaluate treatment response.The significance of the difference among groups was analyzed by means of ANOVA.Results:The sum of the tumor LD prior to treatment,that of after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 sec after injection of contrast medium were(4.48 ± 1.19),(3.98 ± 1.50),(3.35 ± 1.11) cm respectively and there were statistically significant differences among them(F = 4.273,P = 0.018).The sum of the tumor LD prior to treatment was significantly higher than that of the post-treatment tumor enhancement area(P = 0.005).No statistically significant difference in the sum of the tumor LD was found between the pre-treatment and the post-treatment(P = 0.203).There was not statistically significant difference between the sum of the tumors LD prior to treatment and that of after treatment.According to changes in sum of the tumor LD,there were 4 of 22(18.18%) partial responses(PRs),14 of 22(63.64%) stable diseases(SDs),4 of 22(18.18%) progressive diseases(PD) and response rate was 18.18%.According to changes in the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 sec after injection of contrast medium,there were 5 of 22(22.73%) PRs,15 of 22(68.18%) SDs,2 of 22(9.09%) PDs and response rate was 22.73%.Ten cases among 22 appeared homogeneous enhancement at 90 sec prior to treatment.At 25 sec,there were 6 cases with heterogeneous enhancement,2 cases with homogeneous enhancement,1 case with central enhancement,and 1 case with peripheral enhancement among the 10 cases.Six cases appeared homogeneous enhancement and 16 cases heterogeneous enhancement at 90 sec after treatment.At 25 sec,there were 3 cases with heterogeneous enhancement,2 cases with homogeneous enhancement,and 1 case with central enhancement among the six cases.Conclusion:Therapeutic effect may be underestimated with use of changes in sum of the tumor LD.The changes in sum of tumor enhancement area LD is suggested to be used in assessing no-surgical treatment response in bronchogenic carcinoma.The no-surgical treatment kill bronchogenic carcinoma cell and tumor after no-surgical treatment shows a gradual increase to the peak height after administration of contrast material.展开更多
Objective:To objectively evaluate the clinical effect of traditional Chinese medicine in treating children s respiratory syncytial viral pneumonia(RSVP) of phlegm-heat blocking Fei(肺) syndrome(PHBFS). Methods:A singl...Objective:To objectively evaluate the clinical effect of traditional Chinese medicine in treating children s respiratory syncytial viral pneumonia(RSVP) of phlegm-heat blocking Fei(肺) syndrome(PHBFS). Methods:A single-blinded multi-center,blocked,randomized and parallel-controlled method was adopted.The clinical study was carried out on 206 children with RSVP-PHBFS who were assigned to two groups,108 in the test group treated through intravenous dripping of Qingkailing Injection(清开灵注射液) in combination of or...展开更多
Objective:To evaluate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor(Draft,REC-TCM-ST) in application of Chinese medicine therapeutic effect in...Objective:To evaluate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor(Draft,REC-TCM-ST) in application of Chinese medicine therapeutic effect in patients with advanced non-small cell lung cancer(NSCLC).Methods:A retrospective clinical research was used in 104 NSCLC patients in stages of Ⅲ-Ⅳ,53 cases were in Chinese medicine(CM) group and 51 cases were in Western medicine(WM) group.The therapeutic effect of the two groups was evaluated with both REC-TCM-ST and Response Evaluation Criteria in Solid Tumor(RECIST).Kaplan-Meier method was used to analyze the survival time.Kappa test method was used to test the consistency of the two kinds of evaluation results.Results:According to REC-TCM-ST,the effective rate on relieving tumor mass in the CM group was significantly lower than that in the WM group(P〈0.05),but there was no significant difference in tumor-mass stable rate(P〉0.05);the symptom of weakness in the CM group was improved significantly,indicating better therapeutic effect than that in the WM group(P〈0.01).Karnofsky score in the CM group was significantly better than that in the WM group(P〈0.01).In terms of survival conditions,the median survival time and the survival rate of 6 months,1 year and 2 years of the CM group were higher than the WM group.The total effective rate was 9.62%,and the total stable rate was 72.12%for 104 cases according to RECIST;while the total effective rate was 34.62%,and the total stable rate was 84.62%according to REC-TCM-ST,thus there were significant differences between the results of the two criteria(P〈0.01),and there was also some consistency between them,but not satisfactory.Conclusions:REC-TCM-ST was used to evaluate the therapeutic effect of CM in the treatment of advanced NSCLC,which shows that its evaluation results can better reflect the advantages and disadvantages of CM,and the effectiveness of CM is more objective and comprehensive than RECIST,so REC-TCM-ST is worthy of further improvement and clinical expansion.展开更多
Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence...Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases,i.e.PubMed,Excerpt Medica Database,China Biology Medicine disc and China National Knowledge Infrastructure.However,no relevant study on the subjects of interest was identified.Therefore,drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine,we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial.Further,we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders.Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research.The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders.展开更多
Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice.However,evidence from randomized clinical trials(RCTs)remains controversial.Most RCTs conclude that acupun...Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice.However,evidence from randomized clinical trials(RCTs)remains controversial.Most RCTs conclude that acupuncture procedures for chronic low back pain(CLBP)had no significant difference in efficacy and belonged to placebo.We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs.Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture.Inappropriate selection of sham acupuncture controls,rigorous RCT research models,and incorrect interpretation of results may contribute to negative evidence.Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise.Moreover,sham acupuncture is often proven to be non-inert,unreasonable,and with low fidelity.Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided.Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.展开更多
基金Supported by the Olympic Games scientific research project of the General Administration of Sport of China No.2011A020the National Natural Science Foundation of China(No.61172007/F010810)
文摘OBJECTIVE:To observe the therapeutic effect of lumbar tender point deep tissue massage plus lumbar traction on chronic non-specific low back pain using change in pressure pain threshold,muscle hardness and pain intensity as indices.METHODS:We randomly divided 64 patients into a treatment group(32 cases) and a control group(32 cases).Two drop-outs occurred in each group.Patients in the treatment group received tender point deep tissue massage plus lumbar traction and patients in the control group received lumbar traction,alone.We used a tissue hardness meter/algometer and visual analog scale(VAS) to assess the pressure pain threshold,muscle hardness and pain intensity.RESULTS:Following treatment,we obtained the following results in the treatment and control groups,respectively:the pressure pain threshold difference was 1.5±0.8 and 1.1±0.7;the muscle hardness difference was 4.2±1.6 and 3.5±1.3;and the VAS score difference was 1.9±0.9 and 1.4±0.8.Compared to the control group,the treatment group had higher pressure pain threshold(t=2.09,P<0.05),and lower muscle hardness(t=2.05,P<0.05) and pain intensity(t=2.46,P<0.05).CONCLUSION:Lumbar tender point deep tissue massage combined with lumbar traction produced better improvement in pressure pain threshold,muscle hardness and pain intensity in patients with chronic non-specific low back pain than with lumbar traction alone.
基金Supported by Beijing Project of Science and TechnologyPlan (No. D08050703020801)Capital Foundation of Medical Developments (No. SF-2007-Ⅱ-13)Major Discipline Projectof China-Japan Friendship Hospital
文摘It is a common view that the integration of Chinese medicine (CM) and modern Western medicine is an efficient way to facilitate the development of CM. Integrative medicine is a kind of complex interventions. Scientific therapeutic evaluation plays a crucial role in making integrative medicine universally acknowledged. However, the modern method of clinical study, which is based on the concept of evidence-based medicine, mostly focuses on the population characteristics and single interventional factor. As a result, it is difficult for this method to totally adapt to the clinical features of CM and integrative medicine as complex interventions. One possible way to solve this issue is to improve and integrate with the existing method and to utilize the evaluation model on complex interventions from abroad. As an interdisciplinary technique, data mining involves database technology, artificial intelligence, machine learning, statistics, neural network and some other latest technologies, and has been widely used in the field of CM. Therefore, the application of data mining in the therapeutic evaluation of integrative medicine has broad prospects.
文摘To probe the significance of specific IgG4 in sera of patients with cerebral cys ticercosis for diagnosis and therapeutic evaluation Methods Specific IgG4 in sera of patients with cerebral cysticercosis was assessed using colloidal gold labeled mouse anti human IgG4 McAb as probe The results wer e compared with the CT image manifestation Results The specific IgG4 positive rate in sera of patients with cerebral cysticercosis was 97 8%, whereas sera from patients with other kinds of parasitosis or centra l nerve system disease and the control group were all negative, except for a wea k cross reaction of sera from patients with hepatic echinococoosis The determ ination of specific IgG4 in sera of patients with cerebral cysticercosis during different times of treatment showed that along with an increase in treatment tim e and improvement of clinical symptoms, specific IgG4 level gradually decreased The positive rate and intensity of specific IgG4 in sera from patients with c erebral cysticercosis were consistent with the number of cysticercus parasites i n the brain and pathologic changes, such as survival, disintegration, death and calcification Survival of cysticercus in the brain was ABSTRACTly evaluated u sing this technique Conclusions The determination of specific IgG4 in sera is a practical method for diagnosis a nd therapeutic evaluation of cerebral cysticercosis
基金supported by the Collaborative Innovation Center for Clinical and Translational Science by Chinese Ministry of Education&Shanghai,No.CCTS-2022205the“Double World-Class Project”of Shanghai Jiaotong University School of Medicine(both to JZ)。
文摘Spinal muscular atrophy is a devastating motor neuron disease characterized by severe cases of fatal muscle weakness.It is one of the most common genetic causes of mortality among infants aged less than 2 years.Biomarker research is currently receiving more attention,and new candidate biomarkers are constantly being discovered.This review initially discusses the evaluation methods commonly used in clinical practice while briefly outlining their respective pros and cons.We also describe recent advancements in research and the clinical significance of molecular biomarkers for spinal muscular atrophy,which are classified as either specific or non-specific biomarkers.This review provides new insights into the pathogenesis of spinal muscular atrophy,the mechanism of biomarkers in response to drug-modified therapies,the selection of biomarker candidates,and would promote the development of future research.Furthermore,the successful utilization of biomarkers may facilitate the implementation of gene-targeting treatments for patients with spinal muscular atrophy.
文摘This study aimed to develop a guideline for therapeutic drug monitoring(TDM) of vancomycin. We adopted the new guideline definition from the Institute of Medicine(IOM), adhered closely to the six domains of the Appraisal of Guidelines for Research & Evaluation Ⅱ(AGREE Ⅱ), and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome(PICO) and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation(GRADE).
文摘Objective:The aim of this article was to discuss the theory of doctor-patient co-operated evidence-based medical record and set up the preliminary frame of the doctor-patient co-operated evidence-based medical record following the concept of narrative evidence-based medicine.Methods:The information was searched from Pubmed,Embase,CBMdisc,CNKI.A preliminary agreement was reached by referring to the principles of narrative medicine and advises given by experts of digestive system and evidence-based medicine in both Traditional Chinese Medicine and Western Medicine.Result:This research is a useful attempt to discuss the establishment of doctor-patient co-operated evidence-based medical record guided by the direction of narrative evidence-based medicine.Reflection and outlook:Doctor-patient co-operated medical record can be a key factor of the curative effect evaluation methodology system of integrated therapy of Tradition Chinese Medicine and Western Medicine on spleen and stomach diseases.
文摘Objective: To evaluate the efficacy of double-phase contrast material-enhanced computed tomography (CT) in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily. Methods: 52 patients with bronchogenic carcinoma after no-surgical treatment underwent double-phase contrast material-enhanced computed tomography. Two spiral CT scans were obtained at 25 and 90 seconds respectively after nonionic contrast material was administrated via the antecubital vein at a rate of 4 mUs by using an autoinjector. Precontrast and postcontrast attenuation on every scan was recorded and peak height was calculated. Enhancement pattern was evaluated on the images obtained at 25 and 90 seconds after injection of contrast medium. Results: Precontrast attenuation, postcontrast attenuation at 25 and 90 seconds were 42.20 ± 7.43 Hu, 57.35 ± 10.09 Hu and 71.85 ±12.45 Hu, respectively. No statistically significant difference in precontrast attenuation was found between our results in the study and the results in our old study (mean precontrast attenuation 40.70 Hu) which was obtained in cases before therapy (t = 1.455, P = 0.152 〉 0.05). Peak height of bronchogenic carcinoma after no-surgical treatment (29.46 ±10.85 Hu) were significantly lower than that of bronchogenic carcinoma before therapy obtained in our old study (mean peak height 35.79 Hu; t = 4.206, P = 0.001 〈 0.05). 32 of 52 cases showed homogeneous enhancement at 90 seconds. Of the 32 cases, there were 21 with inhomogeneous enhancement, 7 with inhomogeneous enhancement, 2 with central enhancement and 2 with peripheral enhancement at 25 seconds. Conclusion: Bronchogenic carcinoma after no-surgical treatment shows a gradual increase to the peak height after administration of contrast material. Peak heights can reflect the blood supply of bronchogenic carcinoma and might be index for evaluation of no-surgical treatment response in bronchogenic carcinoma.
基金Supported by the Foundation of Guangdong Provincial Ad-ministration of TCM(No .97206)
文摘Objective: To observe the clinical efficacy of Penyanqing Capsule (盆炎清胶囊, PYQC) in treating pelvic inflammation of Qi-stagnation with blood stasis syndrome. Methods: The randomized, single blinded, parallel positive drug controlled method was adopted, with 82 patients assigned into two groups by envelop method. The 42 patients in the treated group received PYQC 3 times a day, 4 capsules each time taken orally; the 40 patients in the control group were given orally Fuyankang tablets (妇炎康片, FYKT) 3 times a day, 6 tablets each time. The therapeutic course for both groups was 2 months, and 2 courses of treatment were given successively to observe the comprehensive effect, changes of symptoms and signs before and after treatment. The effects of PYQC on hemorrheological character in part of the patients and on the pathogenetic chlamydia and mycoplasma were also observed. Results: The total effective rate in the treated group was 83.3%, which was insignificantly different from that in the control group (77.5%, P〉0.05). However, PYQC could significantly lower the hemorrheologic indexes in patients and showed definite influence on the pathogenetic chlamydia and mycoplasma. Conclusion: PYQC has good therapeutic effect in treating chronic pelvic inflammation of Qi-stagnation with blood stasis syndrome, and showed definite effect on chlamydia and mycoplasma.
基金Carry out quality evaluation research of generic medicinal product control based on domestic product,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing,China。
文摘The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.
基金supported by grants from the Key Project of Hubei Science and Technology Support Program,China(No.2013BCB013)the Key Project of Hubei Natural Science Foundation of China(No.2013CFA059)the National Natural Science Foundation of China(No.81270249)
文摘An optimal therapy for pulmonary embolism(PE) was explored by comparing three different methods in order to alleviate the sufferings of PE patients and reduce the mortality. Eighty patients with PE diagnosed by computed tomography angiography(CTA) were treated with thrombolysis, anticoagulation only, or surgery/intervention. The clinical efficacy of different treatments were compared and analyzed. Twenty-four out of the 26 patients(92%) in anticoagulation only group showed improvement in CTA and clinical presentations, which was significantly higher than that in the thrombolysis group(87%, n=39, P〈0.05). However, there was no significant difference in the rate of mortality between thrombolysis group and anticoagulation only group. In the surgery/interventional group(n=15), the success rate was 47%, and the mortality rate was 14%. Both of them were significantly different from those in thrombolysis and anticoagulation only groups(both P〈0.05). Log-rank analysis of the data of 5-year follow-up revealed that the survival time in surgery/intervention group was significantly shorter than in the other two groups(P0.05). It was suggested that it is of importance to choose the appropriate therapeutic regimen for PE patients. Mortality may be reduced and prognosis may be improved with anticoagulation only and thrombolysis therapy.
文摘Objective: The aim of this study was to evaluate the efficacy of changes in enhancement pattern in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily. Methods Thirty-three patients with bronchogenic carcinoma underwent two-phase contrast material-enhanced computed tomography prior to and after stopping no-surgical treatment more than one-month respectively. Two spiral CT scans were obtained at 25 and 90 s respectively after nonionic contrast material was administrated via the antecubital vein at a rate of 3 mL/s by using an autoinjector. The sum of the tumor longest diameters (LD) prior to treatment, after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 s after injection of contrast medium were recorded, Precontrast and postcontrast attenuation on every scan was recorded and peak height was calculated. The significance of the difference among groups was analyzed by means of ANOVA, student t test and chi-square test. Results: The sum of the tumor LD prior to treatment, that of after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 s after injection of contrast medium were (4.49 ± 1.32), (4.05 ± 1.63), (3.36 ± 1.22) cm respectively and there were statistically significant dif- ferences among them (f= 5.467, P = 0.006). The sum of the tumor LD prior to treatment was significantly higher than that of the post-treatment tumor enhancement area (P = 0.001). No statistically significant difference in the sum of the tumor LD was found between the pre- treatment and the post-treatment (P = 0.207). There was no statistically significant difference between the sum of the tumors LD and that of tumor enhancement area after treatment (P = 0.086). The response rate (RR) (21.21%) according to changes in sum of the tumor LD was significantly lower than that (30.30%) according to changes in the sum of the post-treatment tumor enhancement area LD (x2 = 15.12, P 〈 0.05), and the progressive diseases (PD) rate (21.21%) was significantly higher than that (12.12%; X2 = 14.12, P 〈 0.05). No statistically significant difference was found between precontrast attenuation prior to treatment [(41.77±7.03) HU] and that after treatment [(41.89 ± 7.63) HU; t = 0.335, P = 0.740 〉 0.05]. Peak height of bronchogenic carcinoma prior to treatment [(36.50 ± 11.21) HU] were significantly higher than that after treatment [(29.91 ± 10.35) HU; t = 10.081, P = 0.001]. Conclusion: Therapeutic effect may be underestimated with use of changes in sum of the tumor LD. The changes in sum of tumor enhancement area LD in addition to peak height is suggested to be used in assessing no-surgical.treatment response in bronchogenic carcinoma.
文摘Objective:The aim of this study was to evaluate the efficacy of changes in the sum of the enhancement area longest diameters(LD) in assessing no-surgical treatment response in bronchogenic carcinoma preliminarily.Methods:Twentytwo patients with bronchogenic carcinoma underwent two-phase contrast material-enhanced computed tomography prior to and after stopping no-surgical treatment more than one-month respectively.Two spiral CT scans were obtained at 25 and 90 sec respectively after nonionic contrast material was administrated via the antecubital vein at a rate of 3 mL/sec by using an autoinjector.The sum of the tumor LD prior to treatment,after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 sec after injection of contrast medium were recorded.Enhancement pattern was evaluated on the images obtained at 25 and 90 sec after injection of contrast medium.Response Evaluation Criteria In Solid Tumors(RECIST) guidelines were adopted to evaluate treatment response.The significance of the difference among groups was analyzed by means of ANOVA.Results:The sum of the tumor LD prior to treatment,that of after treatment and the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 sec after injection of contrast medium were(4.48 ± 1.19),(3.98 ± 1.50),(3.35 ± 1.11) cm respectively and there were statistically significant differences among them(F = 4.273,P = 0.018).The sum of the tumor LD prior to treatment was significantly higher than that of the post-treatment tumor enhancement area(P = 0.005).No statistically significant difference in the sum of the tumor LD was found between the pre-treatment and the post-treatment(P = 0.203).There was not statistically significant difference between the sum of the tumors LD prior to treatment and that of after treatment.According to changes in sum of the tumor LD,there were 4 of 22(18.18%) partial responses(PRs),14 of 22(63.64%) stable diseases(SDs),4 of 22(18.18%) progressive diseases(PD) and response rate was 18.18%.According to changes in the sum of the post-treatment tumor enhancement area LD on the images obtained at 90 sec after injection of contrast medium,there were 5 of 22(22.73%) PRs,15 of 22(68.18%) SDs,2 of 22(9.09%) PDs and response rate was 22.73%.Ten cases among 22 appeared homogeneous enhancement at 90 sec prior to treatment.At 25 sec,there were 6 cases with heterogeneous enhancement,2 cases with homogeneous enhancement,1 case with central enhancement,and 1 case with peripheral enhancement among the 10 cases.Six cases appeared homogeneous enhancement and 16 cases heterogeneous enhancement at 90 sec after treatment.At 25 sec,there were 3 cases with heterogeneous enhancement,2 cases with homogeneous enhancement,and 1 case with central enhancement among the six cases.Conclusion:Therapeutic effect may be underestimated with use of changes in sum of the tumor LD.The changes in sum of tumor enhancement area LD is suggested to be used in assessing no-surgical treatment response in bronchogenic carcinoma.The no-surgical treatment kill bronchogenic carcinoma cell and tumor after no-surgical treatment shows a gradual increase to the peak height after administration of contrast material.
基金Supported by the National Key Technologies Research and Development Program of China during the 10th Five-Year PlanPeriod(No.2004BA716B03)
文摘Objective:To objectively evaluate the clinical effect of traditional Chinese medicine in treating children s respiratory syncytial viral pneumonia(RSVP) of phlegm-heat blocking Fei(肺) syndrome(PHBFS). Methods:A single-blinded multi-center,blocked,randomized and parallel-controlled method was adopted.The clinical study was carried out on 206 children with RSVP-PHBFS who were assigned to two groups,108 in the test group treated through intravenous dripping of Qingkailing Injection(清开灵注射液) in combination of or...
文摘Objective:To evaluate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor(Draft,REC-TCM-ST) in application of Chinese medicine therapeutic effect in patients with advanced non-small cell lung cancer(NSCLC).Methods:A retrospective clinical research was used in 104 NSCLC patients in stages of Ⅲ-Ⅳ,53 cases were in Chinese medicine(CM) group and 51 cases were in Western medicine(WM) group.The therapeutic effect of the two groups was evaluated with both REC-TCM-ST and Response Evaluation Criteria in Solid Tumor(RECIST).Kaplan-Meier method was used to analyze the survival time.Kappa test method was used to test the consistency of the two kinds of evaluation results.Results:According to REC-TCM-ST,the effective rate on relieving tumor mass in the CM group was significantly lower than that in the WM group(P〈0.05),but there was no significant difference in tumor-mass stable rate(P〉0.05);the symptom of weakness in the CM group was improved significantly,indicating better therapeutic effect than that in the WM group(P〈0.01).Karnofsky score in the CM group was significantly better than that in the WM group(P〈0.01).In terms of survival conditions,the median survival time and the survival rate of 6 months,1 year and 2 years of the CM group were higher than the WM group.The total effective rate was 9.62%,and the total stable rate was 72.12%for 104 cases according to RECIST;while the total effective rate was 34.62%,and the total stable rate was 84.62%according to REC-TCM-ST,thus there were significant differences between the results of the two criteria(P〈0.01),and there was also some consistency between them,but not satisfactory.Conclusions:REC-TCM-ST was used to evaluate the therapeutic effect of CM in the treatment of advanced NSCLC,which shows that its evaluation results can better reflect the advantages and disadvantages of CM,and the effectiveness of CM is more objective and comprehensive than RECIST,so REC-TCM-ST is worthy of further improvement and clinical expansion.
基金Supported by the National Natural Science Foundation of China(No.81303151)Beijing Nova Program(No.xxjh2015A093and No.Z1511000003150125)National Major Scientific and Technological Special Project for"Significant New Drugs Development"(No.2012ZX09303-010-002)
文摘Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases,i.e.PubMed,Excerpt Medica Database,China Biology Medicine disc and China National Knowledge Infrastructure.However,no relevant study on the subjects of interest was identified.Therefore,drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine,we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial.Further,we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders.Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research.The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders.
基金This work was supported by the National Key Research and Development Program-International Cooperation Research on Evaluation of the Effect of Acupuncture on Superiority Diseases(No.2017YFC1703600).
文摘Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice.However,evidence from randomized clinical trials(RCTs)remains controversial.Most RCTs conclude that acupuncture procedures for chronic low back pain(CLBP)had no significant difference in efficacy and belonged to placebo.We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs.Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture.Inappropriate selection of sham acupuncture controls,rigorous RCT research models,and incorrect interpretation of results may contribute to negative evidence.Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise.Moreover,sham acupuncture is often proven to be non-inert,unreasonable,and with low fidelity.Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided.Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.