生殖医学杂志

目的 利用荟萃分析探讨复方玄驹胶囊或联合PDE5抑制剂治疗男性勃起功能障碍(ED)的疗效和安全性。方法 检索PubMed数据库、Cochrane Library、Medline、中国生物医学文献数据库、CNKI数据库、VIP以及万方数据库。检索时间从建库伊始至2021年10月，纳入单用复方玄驹胶囊或联合PDE5抑制剂治疗ED的随机对照治疗(RCTs)或半随机实验(CCTs)并进行方法学的质量评估。文献数据采用RevMan 5.3软件进行统计学分析，并根据异质性进行敏感性分析以及文献的发表偏倚风险评估。结果 最终有11篇RCT文献以及1篇CCT文献纳入此次荟萃分析，共纳入病例933例。荟萃分析结果显示，与单用PDE5抑制剂比较，复方玄驹胶囊联合PDE5抑制剂的显效率[RR=1.46,95%CI(1.22,1.76),Z=4.08,P<0.01]、总有效率[RR=1.14,95%CI(1.06,1.23),Z=3.41,P<0.01]均显著提高。复方玄驹胶囊对于ED的总有效率亦优于PDE5抑制剂(P=0.04)。复方玄驹胶囊联合PDE5抑制剂的不良反应发生率与单独使用PDE5抑制剂相比差异无统计学意义(P>0.05)。此外，联合治疗组对比单用PDE5抑制剂可显著改善患者的IIEF-5评分[WMD=3.49,95%CI(2.08,4.90),Z=4.85,P<0.01]。纳入分析的文献均显示单独或联合应用药物治疗过程中未发生严重的不良反应，患者耐受性较好。结论 复方玄驹胶囊联合PDE5抑制剂可更显著提高疗效以及有效改善IIEF-5评分，且安全性好，但仍需更多的大样本、高质量、多中心的随机对照实验来进行远期验证。

Objective:To explore the efficacy and safety of compound Xuanju capsule alone or combined with phosphodiesterase-5(PDE5) inhibitor in treatment of male erectile dysfunction(ED) by meta-analysis.Methods:PubMed database, Cochrane Library, Medline, Chinese Biomedical Literature Database, CNKI,VIP and Wanfang were retrieved from the beginning of the establishment of the database to October 2021. Randomized controlled trial(RCTs) or controlled clinical trial(CCTs) with compound Xuanju capsules alone or combined with PDE5 inhibitors for ED treatment were included, and methodological quality was evaluated. The data of literatures were analyzed by Revman 5.3 software, and sensitivity analysis and risk assessment of publication bias were carried out according to heterogeneity.Results:Eleven RCT literatures and one CCT study were included in the meta-analysis, and a total of 933 cases were included. Meta-analysis showed that compound Xuanju capsule combined with PDE5 inhibitor significantly improved the curative efficacy[RR=1.46,95%CI(1.22,1.76),Z=4.08,P<0.01] and the total effective rate[RR=1.14,95%CI(1.06,1.23),Z=3.41,P<0.01] compared with the use of PDE5 inhibitors only. The total effective rate of compound Xuanju capsule alone for ED was also better than that of PDE5 inhibitor(P=0.04),and the incidence of adverse reactions was not significantly different from PDE5 inhibitor alone(P>0.05). In addition, the IIEF-5 scores of patients in the combined treatment group were significantly improved compared with those in the PDE5 inhibitor alone[WMD=3.49,95%CI(2.08,4.90),Z=4.85,P<0.01]. These studies showed that there were no serious adverse reactions during drug treatment alone or in combination, and the patients were well tolerated.Conclusions:Compound Xuanju capsule combined with PDE5 inhibitor significantly improve the curative efficacy and IIEF-5 score, with good safety, but more large-scale, high-quality, multi-center randomized controlled trials are still needed for long-term validation.