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阿伐那非治疗勃起功能障碍的有效性和安全性:一项系统评价和荟萃分析。

The effectiveness and safety of avanafil for erectile dysfunction: a systematic review and meta-analysis.

作者信息

Wang Hongtao, Yuan Jinqiu, Hu Xiaolong, Tao Ke, Liu Jiaqi, Hu Dahai

机构信息

Burns Centre of PLA, Department of Burns and Cutaneous Surgery, Xijing Hospital, Fourth Military Medical University , Xi'an , China.

出版信息

Curr Med Res Opin. 2014 Aug;30(8):1565-71. doi: 10.1185/03007995.2014.909391. Epub 2014 Apr 14.

DOI:10.1185/03007995.2014.909391
PMID:24701971
Abstract

OBJECTIVE

To compare the efficacy and safety between different dosages of avanafil for the treatment of erectile dysfunction (ED).

METHODS

PubMed, Cochrane Library, and Embase were searched to identify randomized controlled trials which compared avanafil with placebo, or compared different dosages of avanafil for ED. International Index of Erectile Function-Erectile Function domain score (IIEF-EF), Sexual Encounter Profile Question (SEP) questions 2 and 3, and adverse events were considered as the study outcomes. Both pairwise meta-analysis and network meta-analysis were carried out.

RESULTS

Five studies including 2225 patients were assessed. The pairwise meta-analysis suggested that avanafil was more effective than placebo in improving IIEF-EF (mean difference [MD]: 4.47; 95% confidence interval [CI]: 3.51 to 5.43), SEP-2 (MD: 17.41; 95% CI: 14.03 to 20.79), and SEP-3 (MD: 20.01; 95% CI: 22.98 to 37.22), with an evident dose-response relationship. The effectiveness was significantly different between the 50 mg and 100 mg groups, or between the 50 mg and 200 mg groups, for all outcomes. Overall, avanafil was associated with a significantly higher incidence of any adverse event (risk ratio [RR]: 2.56; 95% CI: 1.66 to 3.94), serious adverse event (RR: 2.78; 95% CI: 1.34 to 5.76), flushing (RR: 6.06; 95% CI: 3.37 to 10.88) and headache (RR: 7.54; 95% CI: 3.52 to 16.12) when compared with placebo. No significant difference in safety was found among various dosage groups.

CONCLUSIONS

Avanafil, from 50 to 200 mg, is effective and well tolerated for the treatment of ED, and an increase in dosage is associated with a significant rise in effectiveness but not with significantly more adverse events.

摘要

目的

比较不同剂量阿伐那非治疗勃起功能障碍(ED)的疗效和安全性。

方法

检索PubMed、Cochrane图书馆和Embase,以确定将阿伐那非与安慰剂进行比较,或比较不同剂量阿伐那非治疗ED的随机对照试验。国际勃起功能指数-勃起功能领域评分(IIEF-EF)、性接触概况问题(SEP)问题2和3以及不良事件被视为研究结局。进行了成对荟萃分析和网状荟萃分析。

结果

评估了5项研究,共2225例患者。成对荟萃分析表明,阿伐那非在改善IIEF-EF(平均差[MD]:4.47;95%置信区间[CI]:3.51至5.43)、SEP-2(MD:17.41;95%CI:14.03至20.79)和SEP-3(MD:20.01;95%CI:22.98至37.22)方面比安慰剂更有效,且存在明显的剂量反应关系。对于所有结局,50mg组和100mg组之间,或50mg组和200mg组之间的有效性存在显著差异。总体而言,与安慰剂相比,阿伐那非的任何不良事件(风险比[RR]:2.56;95%CI:1.66至3.94)、严重不良事件(RR:2.78;95%CI:1.34至5.76)、潮红(RR:6.06;95%CI:3.37至10.88)和头痛(RR:7.54;95%CI:3.52至16.12)的发生率显著更高。各剂量组之间在安全性方面未发现显著差异。

结论

50至200mg的阿伐那非治疗ED有效且耐受性良好,剂量增加与有效性显著提高相关,但不良事件并未显著增多。

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