坦索罗辛治疗良性前列腺增生的疗效和安全性：一项荟萃分析。

Efficacy and safety of tamsulosin for the treatment of benign prostatic hyperplasia: a meta analysis.

机构信息

Department of Surgery, Hospital of Tianjin Port, Tianjin 300456, China.

出版信息

Chin Med J (Engl). 2010 Jan 20;123(2):234-8.

PMID:20137377

Abstract

BACKGROUND

Pharmacological therapy has been considered as the first-line treatment for patients with uncomplicated benign prostatic hyperplasia (BPH). The aim of this study was to evaluate the efficacy and safety of tamsulosin compared with a placebo for treating BPH.

METHODS

The randomized placebo-controlled trials (RCT) of tamsulosin for the treatment of BPH from all over the world were searched. PubMed, Ovid, ScienceDirect, EBSCO, CBM, and CNKI were searched, as well as a manual search of four Chinese journals: Chinese Journal of Andrology, National Journal of Andrology, Chinese Journal of Urology, and Journal of Clinical Urology was also performed. 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 opinions were settled by discussion. Meta-analysis was processed by Rev Man 5.0 software, fail-safe number was performed by SAS8.0 software.

RESULTS

Seven RCTs involving 2455 men met the inclusion criteria. The basic characteristics of patients were comparable in all the studies. Comparing three common criteria: international prostate symptom score (IPSS)/Boyarsky symptom score, maximum flow rate (MFR), quality of life (QOL), tamsulosin was better than placebo at improving IPSS and MFR, with no significant difference in the QOL. Adverse events of tamsulosin also showed no significant difference from the placebo group (Z=1.62, P=0.10, OR=1.22, 95% CI 0.96-1.54).

CONCLUSIONS

Tamsulosin is better than placebo at improving IPSS and MFR. Adverse events of tamsuloisn show no significant difference compared with placebo. More high quality trials with larger samples and longer follow-up are proposed.

摘要

背景

药物治疗被认为是治疗单纯性良性前列腺增生（BPH）患者的一线治疗方法。本研究旨在评估坦索罗辛治疗 BPH 的疗效和安全性。

方法

检索了来自世界各地的坦索罗辛治疗 BPH 的随机安慰剂对照试验（RCT）。检索了 PubMed、Ovid、ScienceDirect、EBSCO、CBM 和 CNKI，并对 4 种中文期刊（《中华男科学杂志》、《中华泌尿外科杂志》、《中国男科学杂志》和《临床泌尿外科杂志》）进行了手工检索。两名审查员独立筛选研究的合格性，评估质量并从合格研究中提取数据，并通过交叉核对进行确认。意见分歧通过讨论解决。使用 Rev Man 5.0 软件进行荟萃分析，使用 SAS8.0 软件进行失效安全数分析。

结果

符合纳入标准的 7 项 RCT 共纳入 2455 名男性。所有研究中患者的基本特征均具有可比性。比较三种常见指标：国际前列腺症状评分（IPSS）/Boyarsky 症状评分、最大尿流率（MFR）、生活质量（QOL），坦索罗辛在改善 IPSS 和 MFR 方面优于安慰剂，QOL 无显著差异。坦索罗辛的不良反应也与安慰剂组无显著差异（Z=1.62，P=0.10，OR=1.22，95%CI 0.96-1.54）。