摘 要 ：目的：评价雷公藤提取物治疗RA的有效性和安全性。方法：收集了全世界关于雷公藤提取物治疗类风湿关节炎的随机对照试验，参照Cochrane Reviewer‘ s Handbook4.2.5中的简单方法和《隐蔽分组（分配隐藏）和盲法的概念、实施与报告》对各试验进行方法学质量评价；采用Cochrane协作网提供的Revman4.2统计软件对各试验进行统计分析；以美国风湿病协会推荐的类风湿关节炎病情疗效标准（ACR20/50/70），X线进展评价以及无效率为疗效指标；亚组分析方面，按对照措施的不同分为“与安慰剂对照亚组”和“与缓解病情药对照亚组”。结果：共有7个临床试验符合纳入标准，样本含量均较小，其中6个存在方法学质量欠缺，存在多种偏倚的可能性。疗效评价方面，雷公藤提取物对缓解类风湿关节炎病情有疗效（P<0.05），在减少肿胀关节数、降低CRP方面的疗效与缓解病情药没有差异，在降低ESR方面比缓解病情药疗效要好（P<0.01）。但在延缓RA骨质破坏方面并无明显疗效。雷公藤提取物不良反应发生率较缓解病情药为高。结论：本系统评价提示雷公藤提取物是缓解类风湿关节炎病情的有效药物，但由于纳入的7个RCTs多为低质量研究，使得结论的可靠性下降，尚需大样本、多中心具有完善试验设计，规范的药物用法以及采用公认可靠的疗效评价标准的RCTs来进一步探索。
Abstract:Objective： To evaluate the efficacy and safety of Tripterygium wilfordii extract (TWE) in treating rheumatoid arthritis. Method： Mainly using the simple methods from the International Cochrane Collaboration as systematic evaluation methods. Using Revman 4.2.5 which Cochrane Cooperation Web recommended to analysis. Using American College of Rheumatology (ACR) core set (ACR20， ACR50， and ACR70) of therapeutic efficacy measures which recommended by ACR， radiographic change of bone and the rate of inefficacy as efficacy methods. Dividing into placebo subgroup and DMARDs (disease modifying anti rheumatism drugs) subgroup according to different control treatments. Result： A total of seven randomized controlled trials (RCTs) were collected. They are all of small sample size， six of which exist some methodological defects， resulting in many possible biases. As evaluated by ACR20/50/70， TWE was as effective as DMARDs in reducing number of swelling joints， level of C-reactive protein (CRP) ， and was more effective than DMARDs in reducing erythrocyte sedimentation rate (ESR) (P<0.01). While TWE was no effect in delaying bone destruction. The incidence of adverse reactions of TWE is higher than DMARDs. Conclusion： TWE can be used as an alternative medicine in treating RA. But owing to lacking of data from high-quality RCTs， however， the efficacy and safety of TWE are desired for further exploration.