甘建平 朱丰林 李延萍 吴斌

【摘 要】目的：评价清热利湿法治疗急性痛风性关节炎疗效和安全性。方法：通过计算机检索中国知网（CNKI）、维普网（VIP）、万方数据库，以及PubMed外文数据库，查找国内外关于清热利湿法治疗急性痛风性关节炎的随机对照试验，检索日期自建库到2015年12月。纳入文献采用Jadad评分，运用Cochrane协作网提供的RevMan 5.3软件进行有效率、药物不良反应的Meta分析。结果：共纳入符合标准文献14篇，Jadad评分高质量文献3篇。Meta分析结果显示：①有效率比较，异质性检验（χ2 = 15.67，df = 13，P = 0.27 > 0.1，I2 = 17% < 50%），数据具有同质性，采用固定效应模式进行Meta分析。合并效应量为2.44，95% CI =[1.68，3.43]，合并效应量的检验 Z = 4.81，P < 0.000 01，差异均有统计学意义。置信区间落在无效线右侧，表明清热利湿法治疗组效应量大于西药对照组。②漏斗图散点分布不对称，提示纳入文献有一定选择性偏倚。③不良反应比较，清热利湿法治疗组不良反应发生率明显低于西药对照组。结论：清热利湿法治疗痛风急性期具有较好临床疗效，且不良反应少。但目前研究存在一些试验设计问题，高质量文献较少，存在一定的选择性偏倚。

【关键词】 痛风性关节炎；急性；清热利湿法；Meta分析；随机对照试验

【ABSTRACT】Objective：To evaluate the efficacy and safety of clearing away heat and eliminating dampness in the treatment of acute gouty arthritis.Methods：Randomized controlled trials on the treatment of acute gouty arthritis by clearing away heat and eliminating dampness at home and abroad were searched through CNKI，VIP，Wanfang database and PubMed database（from the establishment of the database to December 2015）.Jadad was used to score the included literature and Man Rev 5.3 software provided by Cochrane network was used to carry out a Meta analysis of effective and adverse drug reaction.Results：A total of 14 literatures were included in the analysis and three of them had high quality.Meta analysis results：①Efficiency comparison and the test for heterogeneity （χ2 = 15.67，df = 13，P = 0.27 > 0.1，I2 = 17% < 50%） showed that the data had homogeneity.Fixed effect model was used to carry out the Meta analysis.The combined effect was 2.44，95% CI = [1.68，3.43]，and the test of combined effect was Z = 4.81 ，the difference being statistically significant

（P < 0.000 01）.The confidence interval was on the right side of the invalid line，which showed that the effect of the treatment group treated by clearing away heat and eliminating dampness was greater than that of the control group treated with western medicine.②The distribution of the funnel plot was asymmetrical，which suggested that there was a certain selective bias of the literature.③As for the comparison of the adverse reactions，the incidence of adverse reaction of the treatment group was significantly lower than that of the control group.Conclusion：Method of clearing away heat and eliminating dampness has a better clinical effect and less adverse reaction.But there are some experimental design problems at present，and there are only a few high quality literatures，so selective biases are inevitable.

【Keywords】 gouty arthritis；acute；clearing away heat and eliminating dampness；Meta analysis；randomized controlled trials

痛风（gout）是一种尿酸盐沉积所致的晶体相关性关节病，与嘌呤代谢紊乱及（或）尿酸排泄减少所致的高尿酸血症直接相关，属于代谢性风湿病范畴。中医学认为，痛风急性发作以湿热蕴结为主要病机，治疗上常以清热利湿为法。目前已有学者对中医药治疗急性痛风性关节炎（acute gouty arthritis，AGA）的临床疗效进行分析，如宣痹汤加减[1]、二妙散[2]、四妙散[3]等的Meta分析，均证实中药治疗AGA疗效肯定。追溯以上方剂均以清热利湿为主，然目前尚无对清热利湿法治疗AGA有效性和安全性进行系统评估。本文拟通过随机对照试验对清热利湿法系列方剂治疗AGA的疗效进行Meta分析，以评价清热利湿法治疗AGA的有效性和安全性，为后期临床应用提供循证依据。

1 资料与方法

1.1 文献检索 通过计算机检索中国知网（CNKI）、维普网（VIP）、万方数据库，以及PubMed外文数据库，均检索从建库至2015年12月的全部期刊，中文检索词包括“随……