目的 评价桂枝芍药知母汤治疗痛风性关节炎（GA）的有效性与安全性。方法 通过检索中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、中国生物医学文献数据库（CBM）、维普中文期刊全文数据库（VIP）、PubMed、Embase、WebofScience和Cochrane Library等中英文数据库，检索时间为建库至2022年6月桂枝芍药知母汤治疗GA的随机对照试验（RCT）。由2位研究员独立对文献进行筛选、提取数据和质量评价后，运用RevMan 5.3和Stata 14软件进行Meta分析。结果 共纳入12项RCTs，包括1142例患者，其中对照组（常规治疗）570例、试验组（常规治疗联合桂枝芍药知母汤）572例。Meta分析结果显示，与对照组比较，试验组临床有效率更高[RR=1.19，95% CI （1.14，1.25），P<0.00001]，血尿酸显著降低[MD=-89.36，95% CI （-153.66，-25.05），P=0.006]，明显改善红细胞沉降率[MD=-4.84，95% CI （-6.68，-2.99），P<0.000 01]，明显降低C-反应蛋白水平[MD=-2.14，95% CI （-3.19，-1.09），P<0.000 01]，明显改善白细胞介素-6水平[MD=4.39，95% CI （1.27，7.52），P=0.006]，明显降低不良反应[RR=0.26，95% CI （0.16，0.41），P<0.000 01]。敏感性分析提示研究结果具有较好的可靠性和稳定性。结论 桂枝芍药知母汤治疗GA临床疗效显著且安全性好。但文献数量少、质量偏低，仍需更多高质量、多中心、大样本的RCTs加强证据强度。

Objective To evaluate the efficacy and safety of Guizhi-Shaoyao-Zhimu Decoction in the treatment of gouty arthritis(GA).Methods Data were electronically searched from CNKI, Wanfang Data, CBM, VIP, PubMed, Embase, Web of Science and Cochrane Library from establishment of the database to June 2022 for randomized controlled trials of Guizhi-Shaoyao-Zhimu Decoction in treatment of GA.Two researchers independently screened, extracted data and assessed the quality of the literature, and used RevMan 5.3 and Stata 14 software for Meta-analysis.Results A total of 12 RCTs were included into the study, including 1 142 patients, which 570 cases in control group(conventional western medicine treatment) and 572 cases in experimental group(conventional treatment combined with Guizhi-Shaoyao-Zhimu Decoction).Meta-analysis results showed that compared with control group, experimental group had a higher clinical response rate[RR=1.19, 95%CI(1.14, 1.25), P<0.000 01], and a significant decrease in serum uric acid[MD=-89.36, 95%CI(-153.66, -25.05), P=0.006], significantly improved blood cell sedimentation rate[MD=-4.84, 95%CI(-6.68, -2.99), P<0.000 01], significantly decreased C-reactive protein level[MD=-2.14, 95%CI(-3.19, -1.09), P<0.000 01], significantly improved IL-6 level[MD=4.39, 95%CI(1.27, 7.52), P=0.006], and significantly reduced adverse events[RR=0.26, 95%CI(0.16, 0.41), P<0.000 01].Sensitivity analysis indicated that the research results had good reliability and stability.Conclusion Guizhi-Shaoyao-Zhimu Decoction in treatment of GA has significant clinical efficacy and good safety.However, the number and quality of the literature are small, and more high-quality, multi-center, and largesample RCTs are still needed to strengthen the evidence.

R286.7;R969.3

国家中医药管理局基于中医药循证能力建设项目（国中医药科技中医便函[2019]130号）；威海市中医药科技项目（2022Ⅰ-1）；威海市第四批中医重点专科建设项目（威卫办[2019]87号）