中医药治疗中风后抑郁症临床文献的质量评价

目的评价中医药治疗中风后抑郁症（PSD）的疗效与安全性，提出该领域临床研究方法学上存在的问题及对策。方法以循证医学的原则和方法，对2009年以前中国生物医学文献数据库、中国期刊全文数据库、重庆维普中丈科技期刊数据库、PUBMED、EMbase及相关杂志发表的关于中医药治疗PSD的临床随机对照试验（RCT）和临床对照试验（CCT）临床文献进行质量评价。结果符合纳入标准的RCT69篇、CCT6篇，仅11篇随机方法适当，2篇采用盲法，62篇有组间可比性，8篇提及退出和失访情况；纳入试验的方法学Jadad评分3分者4篇；2分者11篇；55篇得分0～1分；中药治疗或中西医结合治疗组有效率高于单纯西药治疗组，无效率、不良事件发生次数和程度低于单纯西药治疗组；有4篇研究可进行Meta分析。结论中医药治疗PSD研究质量有待进一步提高。Meta分析及定性研究所得中药或中西医结合治疗PSD肯定的疗效与安全性证据强度不够，需大样本、多中心、前瞻性的RCT以增加证据可靠性，并随新临床结果的出现不断完善与更新该评价。

Quality Evaluation of Clinical Literature on Chinese Medicinal Therapies of Post-Stroke Depression

Objective To access the effectiveness and safety of traditional Chinese medicine for the patients with post-stroke depression, and provide the evidence for clinical practice. Methods Systematically search （computer and hand） CNKI, VIP, CBM, PUBMED, EMBASE and related magzines for the randomized controlled trials （RCT） and clinical controlled trials （CCT） of traditional Chinese medicine in treating post-stroke depression published. To evaluate and analyze the quality of literature with evidence-based medicine approach. Results 69 RCTs and 6 CCTs met the selection criteria. Only 11 RCTs had proper random methods and 2 RCTs used blind method. There were coparability of groups in 62 RCTs and it was mentioned in 8 researchs of exit and lost. It was showed that the effective rate of treatment group was higher than that of the control group, the ineffective rate and adverse effects in treatment group were lower than that of the control group. 4 RCTs were made Meta analysis and quantitative analysis. 4 trials were 3 using Jadad Scale, 11 trials were 2, other 55 trials were 0-1. Conclusions Large sample, multicentre, prospective randomized trials are needed to strengthen Meta analysis evidence concluded by lower methodological quality of included studies. Furthermore, systematic review should be improved and updated if new evidence appeared.