目的 評價桂枝芍藥知母湯治療痛風(fēng)性關(guān)節(jié)炎（GA）的有效性與安全性。方法 通過檢索中國學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、萬方數(shù)據(jù)庫（Wanfang Data）、中國生物醫(yī)學(xué)文獻數(shù)據(jù)庫（CBM）、維普中文期刊全文數(shù)據(jù)庫（VIP）、PubMed、Embase、WebofScience和Cochrane Library等中英文數(shù)據(jù)庫，檢索時間為建庫至2022年6月桂枝芍藥知母湯治療GA的隨機對照試驗（RCT）。由2位研究員獨立對文獻進行篩選、提取數(shù)據(jù)和質(zhì)量評價后，運用RevMan 5.3和Stata 14軟件進行Meta分析。結(jié)果 共納入12項RCTs，包括1142例患者，其中對照組（常規(guī)治療）570例、試驗組（常規(guī)治療聯(lián)合桂枝芍藥知母湯）572例。Meta分析結(jié)果顯示，與對照組比較，試驗組臨床有效率更高[RR=1.19，95% CI （1.14，1.25），P<0.00001]，血尿酸顯著降低[MD=-89.36，95% CI （-153.66，-25.05），P=0.006]，明顯改善紅細胞沉降率[MD=-4.84，95% CI （-6.68，-2.99），P<0.000 01]，明顯降低C-反應(yīng)蛋白水平[MD=-2.14，95% CI （-3.19，-1.09），P<0.000 01]，明顯改善白細胞介素-6水平[MD=4.39，95% CI （1.27，7.52），P=0.006]，明顯降低不良反應(yīng)[RR=0.26，95% CI （0.16，0.41），P<0.000 01]。敏感性分析提示研究結(jié)果具有較好的可靠性和穩(wěn)定性。結(jié)論 桂枝芍藥知母湯治療GA臨床療效顯著且安全性好。但文獻數(shù)量少、質(zhì)量偏低，仍需更多高質(zhì)量、多中心、大樣本的RCTs加強證據(jù)強度。

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

國家中醫(yī)藥管理局基于中醫(yī)藥循證能力建設(shè)項目（國中醫(yī)藥科技中醫(yī)便函[2019]130號）；威海市中醫(yī)藥科技項目（2022Ⅰ-1）；威海市第四批中醫(yī)重點專科建設(shè)項目（威衛(wèi)辦[2019]87號）