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阿伐那非治疗男性勃起功能障碍的系统评价和随机对照试验的荟萃分析。

Avanafil for the Treatment of men With Erectile Dysfunction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

机构信息

Department of Urology, Nanchong Central Hospital, The Second Clinical Medical College, North Sichuan Medical College, Nanchong, Sichuan, China.

Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.

出版信息

Am J Mens Health. 2019 Sep-Oct;13(5):1557988319880764. doi: 10.1177/1557988319880764.

Abstract

Previous studies have reported the clinical efficacy of avanafil for erectile dysfunction (ED), but these findings are controversial. This study aims to investigate the safety and efficacy of avanafil for ED. EMBASE, PubMed, and Cochrane Library were searched extensively to obtain eligible studies. Clinical outcomes including successful vaginal penetration (SVP), successful intercourse (SI), International Index of Erectile Function-Erectile Function domain (IIEF-EF) score and treatment adverse events (TAEs) were compared using RevMan v.5.3. Eight RCTs involving 3,709 patients were included. The analysis demonstrated that compared with placebo, the SVP (RR = 3.20, 95% CI [2.60, 3.95], < .001), SI (RR = 2.53, 95% CI [2.19, 2.92], < .001), change in IIEF-EF score (MD = 4.57, 95% CI [3.68, 5.46], < .001) and TAEs (RR = 1.78, 95% CI [1.38, 2.31], < .0001) were significantly higher in the avanafil. In addition, avanafil 200 mg were higher than avanafil 100 mg in SI (RR = 0.86, 95% CI [0.75, 0.99], = .03) and change in IIEF-EF score (MD = -1.34, 95% CI [-1.67, -1.01], < .001), but there were no obvious differences in SVP (RR = 0.89; 95% CI [0.74, 1.08], = .23) and TAEs (RR = 0.97, 95% CI [0.83, 1.14], = .74) between the two doses. The present evidence suggests that avanafil (especially 200 mg) has the potential to be the drug of choice for ED, but more strict and larger sample size RCTs are need to validate the findings.

摘要

先前的研究报告了阿伐那非治疗勃起功能障碍(ED)的临床疗效,但这些发现存在争议。本研究旨在探讨阿伐那非治疗 ED 的安全性和疗效。通过检索 EMBASE、PubMed 和 Cochrane Library,获得了符合条件的研究。使用 RevMan v.5.3 比较了包括成功阴道插入(SVP)、成功性交(SI)、国际勃起功能指数-勃起功能域(IIEF-EF)评分和治疗不良事件(TAE)在内的临床结局。纳入了 8 项 RCT,共涉及 3709 名患者。分析结果表明,与安慰剂相比,阿伐那非组的 SVP(RR = 3.20,95%CI [2.60,3.95], <.001)、SI(RR = 2.53,95%CI [2.19,2.92], <.001)、IIEF-EF 评分变化(MD = 4.57,95%CI [3.68,5.46], <.001)和 TAE(RR = 1.78,95%CI [1.38,2.31], <.0001)显著更高。此外,阿伐那非 200mg 组在 SI(RR = 0.86,95%CI [0.75,0.99], =.03)和 IIEF-EF 评分变化(MD = -1.34,95%CI [-1.67,-1.01], <.001)方面均高于阿伐那非 100mg 组,但在 SVP(RR = 0.89;95%CI [0.74,1.08], =.23)和 TAE(RR = 0.97,95%CI [0.83,1.14], =.74)方面无明显差异。目前的证据表明,阿伐那非(尤其是 200mg)有可能成为 ED 的首选药物,但需要更严格和更大样本量的 RCT 来验证这些发现。

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