目的 系统评价补中益气汤加减治疗女性压力性尿失禁(Stress urinary incontinence,SUI)的有效性及安全性.方法 检索中国知网(CNKI),万方(Wanfang),维普资讯中文科技期刊(VIP),中国生物医学(CBM),PubMed,Cochrane Library,EMbase数据库建库至2023年3月1日期间补中益气汤加减治疗女性SUI的随机对照试验,筛选文献,并提取资料后,使用RevMan5.4软件对纳入研究内容进行Meta分析.结果 最终有28篇文献符合纳入标准,经统计共3506例患者,Meta分析结果显示,补中益气汤加减联合西医传统治疗在提高临床有效率(RR=1.27,95%CI[1.22,1.32],P<0.000 01)、I-QOL 评分(MD=-1.24,95%CI[-1.67,-0.81],P<0.000 01),降低 1 h 尿垫试验漏尿量(MD=-1.75,95%CI[-2.73,-0.77],P=0.0004)、ICI-Q-SF 评分(MD=-1.24,95%CI[-1.67,-0.81],P<0.000 01)、24 h 尿失禁次数(MD=-1.16,95%CI[-2.06,-0.26],P=0.01)方面均优于单纯西医传统治疗;有8篇文献提及不良反应,主要为胃肠不适.结论 补中益气汤加减治疗女性SUI有效性显著安全性高,但确切疗效仍有待临床开展大规模、多中心、高质量RCT研究进一步证实.
Efficacy and Safety of Modified Buzhong Yiqi Decoction in Treatment of Female Stress Urinary Incontinence:A Meta-analysis
Objective To systematically evaluate the efficacy and safety of modified Buzhong Yiqi Decoction in the treatment of female stress urinary incontinence(SUI).Methods China National Knowledge Infrastructure(CNKI),Wanfang Data,China Science and Technology Journal Database(VIP),China Biology Medicine disc(CBM),PubMed,Co-chrane Library and EMbase were searched from the inception of the databases to March 1,2023 for randomized controlled trials(RCTs)on the treatment of female SUI.After screening the literature and extracting the data,Meta-analysis was per-formed on the included papers using RevMan 5.4e.Results A total of 28 RCTs were finally included,involving 3 506 pa-tients.The Meta-analysis showed that modified Buzhong Yiqi Decoction combined with conventional western medicine was effective in improving the clinical efficacy(RR=1.27,95%CI[1.22,1.32],P<0.000 01),increasing I-QOL score(MD=-1.24,95%CI[-1.67,-0.81],P<0.000 01),reducing 1-h urine pad test leakage(MD=-1.75,95%CI[-2.73,-0.77],P=0.000 4),lowering ICI-Q-SF score(MD=-1.24,95%CI[-1.67,-0.81],P<0.000 01),and decreasing the number of 24-h urinary incontinence(MD=-1.16,95%CI[-2.06,-0.26],P=0.01),and was superior to conventional western medicine alone.Eight papers mentioned adverse reactions,which were mainly gastrointesti-nal discomfort.Conclusion Modified Buzhong Yiqi Decoction has significant efficacy and high safety in the treatment of female SUI.However,its exact efficacy remains to be further confirmed by large-scale,multicenter,high-quality RCTs.