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磷酸二酯酶 5 抑制剂治疗糖尿病男性勃起功能障碍的疗效和安全性的比较:基于随机对照试验的贝叶斯网状荟萃分析。

Comparative efficacy and safety of phosphodiesterase type 5 inhibitors for erectile dysfunction in diabetic men: a Bayesian network meta-analysis of randomized controlled trials.

机构信息

Department of Urology, Institute of Urology, West China Hospital, Sichuan University, No. 37, Guoxue Alley, Chengdu, Sichuan, 610041, People's Republic of China.

Department of Anesthesiology, West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, People's Republic of China.

出版信息

World J Urol. 2019 Jun;37(6):1061-1074. doi: 10.1007/s00345-018-2583-1. Epub 2018 Dec 6.

Abstract

PURPOSE

To compare the efficacy and safety profiles of different phosphodiesterase-5 inhibitors (PDE5Is) administrations for erectile dysfunction (ED) in diabetic men, including on-demand (PRN) and regular regimens (OAD).

MATERIALS AND METHODS

Searches were carried out in four electronic databases: PubMed (until April 17th, 2017); Scopus (until April 17th, 2017); Embase (until April 17th, 2017); and Cochrane (until April 18th, 2017). The outcomes for this study are as follows: (1) Global Assessment Question (GAQ) positive response rate; (2) changes from baseline to the end of the study in Erectile Function Domain of International Index of Erectile Function (IIEF-EF); and (3) treatment-related adverse events (TRAEs). The comparative effects of PDE5I regimens were analyzed with random-effect models in a Bayesian Framework using the GeMTC R package.

RESULTS

We identified 1056 records, of which 15 randomized trials with 5274 patients were included. The included studies covered eight kinds of PDE5I administration: avanafil PRN; mirodenafil PRN; sildenafil PRN; tadalafil PRN; tadalafil OAD; udenafil PRN; udenafil OAD; vardenafil PRN; and placebo. In surface under the cumulative ranking curve analysis, vardenafil PRN ranked first, third and first, and mirodenafil PRN ranked second, first and second in GAQ, IIEF-EF, and TRAEs, respectively.

CONCLUSIONS

PDE5I administrations were generally efficient and well-tolerated in diabetic men. Among these administrations, vardenafil PRN and mirodenafil PRN seem to have a possible advantage of efficacy and avoiding adverse effects compared to others. There is no significant difference between regular and on-demand regimens of PDE5Is.

摘要

目的

比较不同磷酸二酯酶-5 抑制剂(PDE5Is)给药方案治疗糖尿病男性勃起功能障碍(ED)的疗效和安全性,包括按需(PRN)和常规方案(OAD)。

材料和方法

在四个电子数据库中进行了检索:PubMed(截至 2017 年 4 月 17 日);Scopus(截至 2017 年 4 月 17 日);Embase(截至 2017 年 4 月 17 日);和 Cochrane(截至 2017 年 4 月 18 日)。本研究的结局如下:(1)总体评估问题(GAQ)阳性反应率;(2)国际勃起功能指数(IIEF-EF)勃起功能域从基线到研究结束时的变化;(3)与治疗相关的不良事件(TRAEs)。使用 GeMTC R 包在贝叶斯框架中通过随机效应模型分析 PDE5I 方案的比较效果。

结果

我们确定了 1056 条记录,其中包括 15 项随机试验,共纳入 5274 名患者。纳入的研究涵盖了八种 PDE5I 给药方式:阿伐那非 PRN;米罗那非 PRN;西地那非 PRN;他达拉非 PRN;他达拉非 OAD;乌地那非 PRN;乌地那非 OAD;伐地那非 PRN;和安慰剂。在累积排序曲线分析的表面下,伐地那非 PRN 在 GAQ、IIEF-EF 和 TRAEs 中分别排名第一、第三和第一,米罗那非 PRN 排名第二、第一和第二。

结论

PDE5I 给药方案在糖尿病男性中通常是有效且耐受良好的。在这些给药方案中,与其他方案相比,伐地那非 PRN 和米罗那非 PRN 似乎在疗效和避免不良反应方面具有优势。PDE5Is 的常规和按需方案之间没有显著差异。

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