桂枝芍药知母汤治疗类风湿关节炎的Meta分析

Comparison of efficacy of Guizhi Shaoyao Zhimu Decoction and methotrexate in treatment of rheumatoid arthritis by meta analysis

目的系统评价桂枝芍药知母汤治疗类风湿关节炎的有效性和安全性。方法计算机检索CNKI、VIP、CBM、万方数据库、PubMed数据库,收集以甲氨蝶呤为对照,观察桂枝芍药知母汤治疗类风湿关节炎的临床随机对照研究文献。采用循证医学的方法,评价纳入研究的方法学质量,提取有效数据,采用Rev Man 5.3软件对数据进行Meta分析。结果共纳入8篇随机对照试验文献。Meta分析结果显示,桂枝芍药知母汤治疗类风湿关节炎的总有效率明显优于甲氨蝶呤[RR=1.17,95%CI(1.09,1.25)],差异有统计学意义(P<0.01)。在缩短晨僵时间、改善握力,以及减少关节肿胀数、降低类风湿因子水平方面均优于甲氨蝶呤(P<0.01),且不良反应发生率低[OR=0.20,95%CI(0.10,0.38),P<0.01],但在减少关节压痛数及改善红细胞沉降率方面则较甲氨蝶呤无明显优势。结论桂枝芍药知母汤治疗类风湿关节炎疗效较好,且不良反应低于甲氨蝶呤。但由于纳入文献数量较少且质量较低,不可避免地对Meta分析结果造成一定的影响,所以有关结论仍需将来高质量、大样本的双盲随机对照试验提供更高级别的证据。

Objective To systematically evaluate the efficacy and safety of Guizhi Shaoyao Zhimu Decoction in treating rheumatoid arthritis.Methods Based on the literature analysis and evaluation method of evidence-based medicine,we searched CNKI,VIP,CBM,Wanfang database and PubMed database,and collected the clinical evidence of Guizhi Shaoyao Zhimu Decoction in the treatment of rheumatoid arthritis with methotrexate(MTX)as control.The quality of the methodology was evaluated,the effective data were extracted,and the Rev Man 5.3 software was used to analyze the data by meta analysis.Results A total of 8 RCTs were included.Meta analysis showed that the total effective rate of Guizhi Shaoyao Zhimu Decoction in the treatment of rheumatoid arthritis(RR=1.17,95%CI[1.09,1.25])was significantly better than that of MTX.The difference was statistically significant(P<0.01).Guizhi Shaoyao Zhimu Decoction was better than MTX(P<0.01)in shorting the time of morning stiffness,improving grip strength,reducing joint swelling,lowing rheumatoid factor(RF),with the low incidence of adverse reactions(OR=0.20,95%CI[0.10,0.38],P<0.01).However,there was no significant advantage in reducing joint tenderness and improving ESR compared with MTX.Conclusion Guizhi Shaoyao Zhimu Decoction has better curative effect on rheumatoid arthritis and the adverse reaction is lower than MTX.However,due to the low quantity and low quality of the literature included,the results of meta analysis were inevitably affected.Therefore,high-quality,large-sample double-blind randomized controlled trials are still needed to provide higher level of evidence.