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目的:评价雷公藤提取物(Tw HF)治疗类风湿关节炎(RA)的疗效和安全性。方法:检索Pub Med、Medline、EMbase、Cochrane、CNKI、Sino Med及万方等数据库(时间截止至2016年5月),同时手工检索相关杂志和参考文献,选择符合标准的文献。按Cochrane系统评价方法,评价纳入研究的方法学质量评价并提取有效数据,采用RevMan5.2软件进行Meta分析。结果:共纳入10个随机对照试验(RCT),Tw HF与安慰剂相比,两组结局指标中的握力、关节肿胀及血清RF、急性时相反应物红细胞沉降率(ESR)的差异均有统计学意义(P<0.05);Tw HF与改善病情抗风湿药(DMARDs)比较,晨僵及类风湿因子(RF)的差异有统计学意义(P<0.05);Tw HF+DMARDs与DMARDs相比,关节肿胀及ESR的差异均有统计学意义(P<0.05);Tw HF+DMARDs与两种DMARDs联用比较,关节疼痛数(TJC)、关节肿胀数(SJC)、ESR及C-反应蛋白(CRP)的差异均有统计学意义(P<0.05)。结论:本系统评价提示Tw HF是缓解RA病情的有效药物,但Tw HF治疗RA的疗效和安全性尚需要高质量大样本RCT进一步验证。
Objective: To evaluate the efficacy and safety of Tripterygium wilfordii extract (Tw HF) in the treatment of rheumatoid arthritis (RA). Methods: PubMed, Medline, EMbase, Cochrane, CNKI, SinoMed and Wanfang databases were searched (as of May 2016). Meanwhile, relevant magazines and references were searched by hand, and the corresponding documents were selected. According to the Cochrane systematic review method, the methodological quality of the included studies was evaluated and valid data was extracted. Meta-analysis was performed using RevMan5.2 software. Results: A total of 10 randomized controlled trials (RCTs) were included. The differences in grip strength, joint swelling, serum RF, acute phase reactant erythrocyte sedimentation rate (ESR) between the two arms of the Tw HF group compared with placebo (P <0.05). The differences of morning stiffness and rheumatoid factor (RF) between Tw HF and DMARDs were statistically significant (P <0.05). Compared with DMARDs (P <0.05). The combination of Tw HF + DMARDs with two DMARDs, joint pain count (TJC), joint swelling (SJC), ESR and C-reaction Protein (CRP) differences were statistically significant (P <0.05). CONCLUSIONS: This systematic review suggests that Tw HF is an effective drug for the relief of RA disease. However, the efficacy and safety of Tw HF in the treatment of RA require further validation by large, high quality RCTs.