泽桂癃爽胶囊治疗良性前列腺增生的系统评价

A Systematic Evaluation on Zeguilongshuang Capsules for Treating Benign Prostatic Hyperplasia

目的系统评价泽桂癃爽胶囊治疗良性前列腺增生(BPH)的疗效及安全性。方法计算机检索Cochrane图书馆(2014年第1期)、EMBase、Pub Med、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)中(各数据库检索时间均从创建至2014年4月)关于泽桂癃爽胶囊治疗BPH的随机对照试验(RCT)。由2名数据员按纳入与排除标准独立筛选试验,并对纳入研究的方法学质量进行评价,提取资料;用Rev Man 5.2软件对数据进行Meta分析。结果共纳入7个RCT,627例患者。Meta分析结果显示,与对照组比较,泽桂癃爽胶囊治疗BPH改善国际前列腺症状评分(I-PSS)较优[MD=-2.48,95%CI(-4.51,-0.45),P<0.05],增加最大尿流率(Qmax)较优[MD=2.01,95%CI(0.57,3.46),P<0.05],减少残余尿量(RU)较优[MD=-5.60,95%CI(-9.87,-1.33),P<0.05],减小前列腺质量、体积较优(P<0.05)。泽桂癃爽组与对照组部分患者有轻微不良反应,不影响治疗。结论基于现有临床证据,泽桂癃爽胶囊治疗BPH安全、有效,但因纳入研究质量不统一,故此结论尚需更多大样本、高质量临床随机对照试验予以证实。

Objective To systematically evaluate the effectiveness and safety of Zeguilongshuang Capsules for treating benign prostatic hyperplasia（ BPH）. Methods The randomized controlled trials（ RCTs） of Zeguilongshuang Capsules for treating BPH were retrieved from the databases of the Cochrane Library（ issue 1,2014）,EMbase,Pub Med,CNKI,CBM and VIP（ from their establishment to April 2014） by computer. Two reviewers independently retrieved RCTs according to the inclusion and exclusion criteria,assessed the methodological quality of included trials,and extracted data. The data analysis was performed by the Rev Man 5. 2 software. Results 7 RCTs involving 627 patients were ultimately identified. The meta analysis results showed that Zeguilongshuang Capsules was superior to the control group in the aspects of the improvement of I- PSS [ MD =- 2. 48,95% CI（- 4. 51,- 0. 45）,P〈 0. 05 ],increase of Qmax[ MD = 2. 01,95% CI（ 0. 57,3. 46）,P〈 0. 05],decrease of residual urines volume（ RU） [ MD =- 5. 60,95% CI（- 9. 87,- 1. 33）,P〈 0. 05],and decrease of prostate＇s volume and weight（ P〈 0. 05）. The differences had statistical significance. The partial patients in the Zeguilongshuang Capsules and the control group had mild adverse reactions without affecting treatment. Conclusion Based on the current evidence,Zeguilongshuang Capsules is safe and effective for treating BPH. However,due to the quality disunity in the included RCTs,more large sample size,high- quality RCTs are needed to conduct the verification.