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西洛多辛治疗良性前列腺增生症的疗效和安全性:系统评价和荟萃分析。

The efficacy and safety of silodosin in treating BPH: a systematic review and meta-analysis.

机构信息

Department of Urology, Beijing Tian-Tan Hospital, Capital Medical University, No. 6 Tiantan Xi Li, Dongcheng District, Beijing, 100050, China.

出版信息

Int Urol Nephrol. 2012 Dec;44(6):1601-9. doi: 10.1007/s11255-012-0261-6. Epub 2012 Aug 24.

Abstract

PURPOSE

Pharmacological therapy is typically the first-line treatment for patients with benign prostatic hyperplasia (BPH). We carried out a systematic review and meta-analysis to assess the efficacy and safety of silodosin for treating BPH.

METHODS

A literature review was performed to identify all published randomized placebo-controlled trials (RCT) of silodosin for the treatment of BPH. The search included the following databases: PUBMED, EMBASE, and the Cochrane Controlled Trail Register of Controlled Trials. The reference lists of retrieved studies were also investigated. A systematic review and meta-analysis were conducted.

RESULTS

Four publications involving a total of 2,543 patients were used in the analysis, including 3 RCTs that compared silodosin with placebo and 3 RCTs that compared silodosin with tamsulosin. We found that silodosin was effective in treating BPH in our meta-analysis. Total international prostate symptom score (IPSS) (P=0.92 SWD=2.92 95% CI=2.19-3.65 the mean decrease of total IPSS was from 6.4 to 10.6), voiding symptom score, storage symptom score, and quality-of-life score indicated that silodosin was more effective than the placebo. Silodosin's efficacy is similar to that of tamsulosin (P=0.37 SWD=1.14 95% CI=0.18-2.11) in our meta-analysis. However, the incidence of abnormal ejaculation was higher in patients treated with tamsulosin therapy compared with the placebo (234/1128=20.74% 12/680=1.76% 6/736=0.82%).

CONCLUSIONS

This meta-analysis proves silodosin to be an effective and safe treatment for the relief of lower urinary tract symptom associated with BPH. Silodosin and tamsulosin were similar in terms of efficacy. The major adverse event associated with silodosin treatment was abnormal ejaculation.

摘要

目的

药物治疗通常是治疗良性前列腺增生(BPH)患者的一线治疗方法。我们进行了系统评价和荟萃分析,以评估西洛多辛治疗 BPH 的疗效和安全性。

方法

对西洛多辛治疗 BPH 的所有已发表的随机安慰剂对照试验(RCT)进行文献回顾。搜索包括以下数据库:PubMed、EMBASE 和 Cochrane 对照试验注册中心。还调查了检索研究的参考文献列表。进行了系统评价和荟萃分析。

结果

共有 2543 名患者的 4 项研究纳入分析,包括 3 项比较西洛多辛与安慰剂的 RCT 和 3 项比较西洛多辛与坦索罗辛的 RCT。我们发现,在荟萃分析中,西洛多辛治疗 BPH 是有效的。国际前列腺症状评分(IPSS)总分(P=0.92 SWD=2.92 95%CI=2.19-3.65,总 IPSS 平均下降从 6.4 降至 10.6)、排尿症状评分、存储症状评分和生活质量评分表明,西洛多辛比安慰剂更有效。西洛多辛的疗效与坦索罗辛相似(P=0.37 SWD=1.14 95%CI=0.18-2.11)。然而,坦索罗辛治疗组患者异常射精的发生率高于安慰剂组(234/1128=20.74%,12/680=1.76%,6/736=0.82%)。

结论

本荟萃分析证明西洛多辛是治疗与 BPH 相关的下尿路症状的有效且安全的治疗方法。西洛多辛和坦索罗辛在疗效方面相似。与西洛多辛治疗相关的主要不良事件是异常射精。

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