群随机试验与传统随机试验统计方法对比分析

目的 介绍群随机试验的统计方法并与传统方法比较。方法 以青少年戒烟干预试验为例 ,介绍群随机试验的假设检验及样本含量估计方法。结果 用传统统计方法分析群随机试验会产生虚假的统计显著性结论 ,增大了Ⅰ型错误 ;用传统样本含量计算公式将低估群随机试验所需的样本含量 ,增大了Ⅱ型错误。

真实世界证据

真实世界证据是在现实医疗环境中,通过优化分析来源于多种途径的数据而获得的证据。其与传统临床研究证据的本质区别在于获取数据的环境,而非研究方法或试验设计。与传统随机对照临床试验证据相比,真实世界证据具有结果外推性好、研究效率高等优势,可广泛应用于医疗产品有效性和安全性评价、临床实践过程分析等领域。近年来,随着信息技术的飞速发展和医学循证需求的持续增加,真实世界研究愈发受到人们重视,发展前景良好。

Traditional Chinese Medicine for the treatment of influenza: a systematic review and Meta-analysis of randomized controlled trials

OBJECTIVE: To justify the clinical use of Traditional Chinese Medicine(TCM) in the treatment of influenza.METHODS: MEDLINE, EMBASE, Chinese Biomedical Literature Database, China National Knowledge Infrastructure Database, China Science and Technology Journal Database, Wanfang Database and the Cochrane Database of Systematic Reviews were searched from thedate of inception until January 1,2013, for the literature on treatment of influenza with TCM.RESULTS: A total of 7 randomized controlled trials were identified and reviewed. Of these trials, 2 compared a(modified) prescription of TCM with oseltamivir and 5 compared a patent traditional Chinese drug with oseltamivir. Based on the Meta-analysis,compared to oseltamivir, the(modified) prescription had similar effect in defervescence [WMD=5.66, 95% CI(﹣32.02, 43.35), P=0.77] and viral shedding [WMD=﹣ 6.21, 95% CI(﹣84.19, 71.76), P=0.88], and the patent traditional Chinese drug also had similar effect in viral shedding [WMD=﹣ 0.24,95% CI(﹣4.79, 4.31), P=0.92] but more effective in defervescence [WMD=﹣4.65, 95%CI(﹣8.91, ﹣0.38),P=0.03].CONCLUSION: TCM has potential positive effects in the treatment of influenza.

Effects of Chinese herbs in children with Henoch-Schonlein purpura nephritis:a randomized controlled trial

OBJECTIVE:To research the curative effect of Chinese herbs for clearing away heat,promoting diuresis,nourishing the kidney,and consolidating essence in children with Henoch-Schonlein purpura nephritis(HSPN)with internal accumulation of damp-toxin using randomized controlled observations on large samples.To seek the mechanism of the therapy and its scope of indications.METHODS:Overall,186 children with HSPN were randomly divided into two groups:treatment group(n=126)treated with Chinese herbs for clearing heat and promoting diuresis and a control group(n=60)treated with Western Medicine.The treatment was carried out for three courses of 4weeks each.We recorded changes in patient urine routines,24 h urinary protein,blood-coagulating series,immunoglobulin and T-cell subgroups,and improvements in main symptoms.We evaluated the alleviation of clinical symptoms and the improvement of proteinuria,hematuria,and other lab-oratory test results.Finally,we analyzed the patient population suitable for this therapy according to the relationship between the grouping of patient body weight and curative effect.RESULTS:Damp-heat syndrome improved in the treatment group,with a significant difference in total effective rate after a 4-week treatment(χ2=13.5220,P=0.0002)and in curative rate after a12-week treatment(χ2=6.3410,P=0.0118),compared to those in the control group.The curative effect in the treatment group was greater than that in the control group but there was no statistical difference between the two groups.The curative effect after a 4-week treatment of patients in the treatment group weighing 30 kg or less based on Traditional Chinese Medicine(TCM)signs and urinary protein was significantly greater than that in the control group.However,there was no statistical difference in the curative effect on urinary red cells and various indexes after a 12-week treatment between the two groups.CONCLUSION:Therapy for clearing away heat,promoting diuresis,nourishing the kidney,and consolidating essence using TCM is effective in children with HSPN from internal accumulation of damp-toxin.The therapy is especially suitable for patients weighing 30 kg or less.The curative effect may be related to the improvement of immune function and blood-coagulation.

Meta-analysis of Traditional Chinese Medicine in treating functional dyspepsia of liver-stomach disharmony syndrome

OBJECTIVE： To systematically assess the clinical ef- fectiveness of traditional Chinese medicine （TCM） in the treatment of functional dyspepsia （FD） of liv- er-stomach disharmony syndrome by meta-analysis. METHODS： Random controlled trials （RCTs） were retrieved from databases, including Pubmed, China national knowledge infrastructure, Wanfang Data, VlP Information, and the Cochrane Library. Trials were selected according to inclusion criteria. The ef- fects of traditional Chinese medicine （TCM） versus prokinetic agents in the treatment of functional dyspepsia （FD） of liver-stomach disharmony syn- drome were compared by meta-analysis. RevMan 5.0.24 was used for data analysis. The effective rate was assessed by odds ratios （ORs）, and 95% confi- dence intervals （C＇/s） were calculated. The cure rate was analyzed by the Peto OR. Simple statistica~ anal- ysis was chosen to assess the frequency of pre- scribed Chinese herbs in treating this syndrome.RESULTS： Thirteen trials were included, involving 1153 patients, and these were of poor methodolog- ical quality. Twelve studies mentioned the effective rate and cure rate. TCM therapy showed a better clinical effect rate compared with that with proki- netic agents [OR： 3.2, 95% CI （2.27, 4.51）]. The TCM group also had a better cure rate than that in the group of prokinetic agents [Peto OR： 2.26, 95% CI （1.61, 3.18）]. With regard to the frequency of Chi- nese herbs used in these 13 trials, Baishao （Radix Paeoniae）, Chaihu （Radix Bupleuri）, and Gancao （Ra- dix Glycyrrhizae） were mostly prescribed, followed by Xiangfu （Rhizoma Cyperi）, Zhishi （Fructus Auran- tii Immaturus）, Zhiqiao （Fructus Aurantii）, Foshou （Citrus medica var.sarcodactylis）, and Chenpi （Peri- carpium Citri Reticulatae）. No serious adverse ef- fects were reported. CONCLUSION： TCM therapy shows a superior effec- tive rate and cure rate compared with those in pro- kinetic agents in the treatment of FD of liver-stom- ach disharmony syndrome. However, further strict- ly designed RCTs are required because of the poor quality of included trials.

Effect of Chinese herbs on immunoglobulin A nephropathy:a randomized controlled trial

OBJECTIVE: The accumulation of extracellular matrix (ECM) is one of the main causes of renal fibrosis. Emerging evidence suggests that the metabolic enzyme of ECM is associated with renal fibrosis. In this study, we applied randomly controlled trial to check the curative effect of Chinese herbs on patients with immunoglobulin A nephropathy (IgAN). METHODS: Twenty-six patients were randomly divided into group A (control group) treated with Western Medicine and group B (treatment group) treated with combination of Traditional Chinese Medicine (TCM) and Western Medicine. Blood and urine tests were done before treatment and after 8-week treatment. RESULTS: The levels of the main composition of ex- tracellular matrix (MC-ECM), the metabolic enzyme of ECM (ME-ECM) and some cytokines in group B decreased more obviously than those in group A after 8-week treatment. So did the level of 24-hour urine protein. However, Metal matrix protease (MMP)-2 and vascular endothelial growth factor in group B increased more obviously than those in group A after 8-week treatment. No effects on the renal function were found in both groups. CONCLUSION: Our study provided important information on using the combination of TCM with Western Medicine to inhibit the progression of renal fibrosis in patients with IgAN.

Effect of Jianpi therapy in treatment of chronic obstructive pulmonary disease:a systematic review

OBJECTIVE： To evaluate the efficacy of Jianpi thera- py in Traditional Chinese Medicine （TCM） for treat- ment of chronic obstructive pulmonary disease （COPD） in stable phase by performing a systematic review and meta-analysis. METHODS： The literatures concerning randomized controlled trials （RCTs） and quasi-RCTs comparing TCM treatment plus Western Medicine （WM） treat- ment with TCM alone, orTCM treatment vs no treatment, placebo for stable phase of COPD were searched in PubMed （1990-December 2010）, in Eng- lish and using Chinese National Knowledge Infra- structure （CNKI, 1990-December 2010）, Chinese Bio- medical Database （1990-December 2010）, Wang- fang Database （1990-December 2010）, and Weipu （VlP） Database in Chinese. The quality assessment and data extraction for RCTs were conducted by two reviewers independently. Jadad scale and allo-cation concealment were used to assess the quality of the included studies, and meta-analyses were conducted with the Collaboration＇s Revman 5.0 software. RESULTS： Seventeen RCTs or quasi-RCTs involving 1269 patients were included. The methodological quality was poor in all trials except one trial （Jadad score=4）. In the meta-analysis, TCM-WM treatment was significantly superior to WM treatment in cure rate [0R=3.82, 95%C/（2.45, 5.95）], and the effective rate between TCM treatment and placebo also had significant difference [0R=4.31, 95%C/（2.35, 7.91）]. Moreover, pulmonary function of the patients in TCM-WM group and TCM group was significantly improved [forced vital capacity （FVC）, P=O.01, quali- ty of life, P〈O.O01 ]. CONCLUSION： The experience in TCM-WM treat- ment of COPD in stable phase was encouraging. The current evidence shows that TCM-WM treat- ment might be more efficient in effective rate, qual- ity of life, and FVC than WM treatment alone. But for forced expiratory volume in one second （FEVl） and FEV1/FVC, no matter TCM-WM treatment com- pared with WM treatment alone or TCM treatment compared with placebo, there was no significant difference, with no obvious adverse reactions. Due to the low methodological quality of trials includ- ed, more RCTs of high quality in large scale are re- quired.