真空负压勃起装置联合PDE5抑制剂治疗勃起功能障碍患者的疗效和安全性Meta分析  

Vacuum erection device and Phosphodiesterase-5 inhibitors for the treatment of erectile dysfunction:a systematic review and Meta-analysis of randomized controlled trials

作　　者：安琪 梁小薇 卢文红 贾艳飞[2] 张开舒[2] 谷翊群 

机构地区：[1]国家卫生和计划生育委员会男性生殖健康重点实验室国家卫生计生委科学技术研究所,北京100081 [2]北京协和医学院研究生院,100730

出　　处：《中华生殖与避孕杂志》2017年第4期311-319,共9页Chinese Journal of Reproduction and Contraception

摘　　要：目的观察真空负压勃起装置(VED)联合PDE5抑制剂治疗男性勃起功能障碍(ED)的疗效。方法检索Cochrane Library、Medline、中国生物医学文献数据库、中国知网、维普以及万方数据库。检索时间从建库至2016年12月,纳入VED联合PDE5抑制剂治疗ED的随机对照治疗(RCTs)并进行方法学的质量评估。文献数据采用Rev Man5.3软件进行统计学分析,并根据异质性进行敏感性分析和发表偏倚风险评估。结果 10篇RCT文献纳入本项研究,累计病例1 327例。Meta分析结果显示:联合治疗组在改善患者满意度方面[RR=1.34,95%CI(1.17,1.54),P<0.01]具有明显优势且差异具有统计学意义,并且单独应用VED亦可改善患者满意度[RR=1.27,95%CI(1.11,1.46),P<0.01]。联合治疗组可明显提高患者的IIEF评分[WMD=4.52,95%CI(2.54,6.50),P<0.01],而在单独应用VED提高患者IIEF评分方面[WMD=-2.07,95%CI(-6.17,2.03),P>0.05],与对照组相比差异并无统计学意义。研究报道VED使用过程中未发生严重的不良反应,患者耐受性好。结论 VED联合PDE5抑制剂可更有效地改善ED患者的满意度,并显著提高IIEF-5评分,是治疗男性ED的有效方式,但仍需更多的大样本、高质量、多中心的随机对照实验加以远期验证。Objective To explore efficacy and tolerabitity of vacuum erection device （VED） combined with Phosphodiesterase-5 inhibitions （PDE5i） in the treatment of male erectile dysfunction （ED）. Methods All the studies regarding the combination of vacuum erection device and PDE5i were collected from the databases, including PubMed, Embase, CBM, CNKI, VIP and Wanfang as well. Meta-analysis was performed by Revman 5.3 software. Effect sizes were computed using Cohen＇s D, and I^2 test was used to assess heterogeneity. Results A total of 10 studies were included, involving 1 327 cases. The results of Meta-analysis showed that combination treatment group [RR= 1.34, 95% CI（1.17, 1.54）, P〈0.01] and VED group [RR=1.27, 95% CI （1.11, 1.46）, P〈0.01] had significant differences when compared with PDE5i group. Moreover, combination treatment group had great improvement in IIEF-5 scores [WMD= 4.52, 95% CI （2.54, 6.50）, P〈0.01] while VED group [WMD=-2.07, 95% C1 （%.17, 2.03）, P〉0.05] did not. Conclusion Current evidence indicates that the combination of PDE5i and VED are effective and safe for the treatment of sexual dysfunction in patients experiencing ED. The conclusion still needs more large-scale, high quality and multi-center studies to be validated.

关 键 词：真空负压勃起装置(VED) PDE5抑制剂 西地那非 勃起功能障碍(ED) 循证医学 META分析 

分 类 号：R698.1[医药卫生—泌尿科学]