坦索罗辛治疗良性前列腺增生疗效及安全性的Meta分析

Efficacy and safety of tamsulosin for the treatment of benign prostatic hyperplasia:a Meta-analysis

目的评价坦索罗辛(tamsulosin)在安慰剂对照下治疗BPH的疗效以及安全性。方法搜集世界范围内运用坦索罗辛和安慰剂对比治疗BPH随机对照试验(RCT)的英文及中文文献,并追查已纳入文献的参考文献。计算机检索:Pubmed,Ovid,ScineceDirect,NGC,EBSCO,EMBASE,CNKI,CBM;手工检索:《中华泌尿外科杂志》、《临床泌尿外科杂志》、《中国男科学杂志》、《中华男科学杂志》四种相关杂志。由两位系统评价员做独立文献筛查、质量评价和资料提取,并交叉核对,不同意见时经过讨论或请第三者裁决。使用统计软件Rev Man5.0完成Meta分析,SAS8.0计算失安全系数。结果经筛选,最后纳入7篇文献,均是以安慰剂作对照的RCT,包括受试患者2263例,进行Meta分析,其基线情况具有可比性。通过比较用药前后3个判效指标,即国际前列腺症状评分(IPSS)/Boyarsky症状评分、最大尿流率(MFR)发现坦索罗辛均优于安慰剂,且经统计学分析后均有统计学意义;生活质量(QOL)的评价仅纳入1篇文献,结果尚不能认为两组间有差异;其不良反应与安慰剂相比差异无统计学意义[Z=1.62(P=0.10),OR为1.22,95%CI(0.96,1.54)]。结论坦索罗辛能够改善良性前列腺增生引起的相关症状(IPSS,MFR),其疗效优于安慰剂,不良反应与安慰剂相比无差异。建议进行大样本、长期随访的高质量临床试验,提供更佳循证证据。

Objective To evaluate the efficacy and safety of tamsulosin for treating benign prostatic hyperplasia（BPH）compared with placebo. Methods The data of randomized controlled trials（RCT）of both Chinese and English studies on tamsulosin for the treatment of BPH all over the world were retrieved from Pubmed, Ovid, ScineceDirect, NGC, EBBS, EMBASE, CNKI, CBM, as well as manually retrieved from four Chinese journals： Chinese of Journal of Androloy, National Journal of Androlgy, Chinese Journal of Urology,Journal of Clinical Urology. Two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation by cross-checking. Divergences of opinion were settled by discussion or consulted by the expert. Meta-analysis was processed by Rev Man 5.0, and fail-safe number（ Nfs）was performed by SASS. 0. Results Seven RCT studies involving 2 263 men, compared with placeo in Meta analysis, were enrolled according to the inclusion criteria. The baseline characteristics of patient was comparable in all the studies. By comparing the changes of three common criteria, including international prostate symptom score（IPSS）/Boyarsky symptom score, maximum flow rate（MFR）, quality of life（QOL）, the results showed that tamsulosin was better than placebo for improving IPSS and MFR, and there was no difference about QOL which was found only one article. Adverse events of tamsuloisn had no significant difference compared with placebo[ Z = 1.62 （P = 0.10）, OR = 1.22,95 % CI（0. 96,1. 54） ]. Conclusion The available evidence indicates that tamsulosin is better than placebo for improv- ing IPSS and MFR. Adyerse events of tamsuloisn have no significant difference compared with placebo. More high quality trials with large samples and longer follow-up will be better for understanding the difference between tamsulosin and placebo.