氟班色林治疗绝经前女性性欲低下的疗效和安全性的Meta分析

Efficacy and Safety of Flibanserin for Hypoactive Sexual Desire Disorder in Premenopausal Women:A Meta-analysis

目的系统评价氟班色林治疗绝经前女性性欲低下的疗效和安全性。方法计算机检索Pub Med、EMbase、MEDLINE、The Cochrane Library(2014年第7期)、CBM、CNKI、VIP和Wan Fang Data数据库,纳入氟班色林治疗绝经前女性性欲低下的随机对照试验(RCT),检索时限均为建库至2014年8月。由2位研究者按照纳入与排除标准筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.3软件进行Meta分析。结果共纳入4个RCT,3 881例患者。Meta分析结果显示:与安慰剂组相比,氟班色林组患者满意性活动(SSE)数量增加[MD=0.72,95%CI(0.51,0.92),P<0.000 01],e Diary性欲评分[MD=2.21,95%CI(1.45,2.97),P<0.000 01]、FSFI域性欲评分[MD=0.29,95%CI(0.24,0.35),P<0.000 01]和FSFI总评分[MD=1.82,95%CI(1.47,2.17),P<0.000 01]提高,而FSDS-R(项目13)评分[MD=–0.24,95%CI(–0.31,–0.17),P<0.000 01]、FSDS-R总评分[MD=–2.70,95%CI(–3.43,–1.96),P<0.000 01]降低。氟班色林组不良反应发生率高于安慰剂组[OR=1.31,95%CI(1.11,1.54),P=0.001]。结论现有证据表明,氟班色林治疗绝经前女性性欲低下具有良好的疗效,但可能会增加不良反应的发生率。

Objective To systematically review the efficacy and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. Methods We searched PubMed, EMbase, MEDLINE, The Cochrane Library （Issue 7, 2014）, CBM, CNKI, VIP and WanFang Data from their inception to August 2014, to collect randomized controlled trials （RCTs） on the effectiveness and safety of flibanserin for hypoactive sexual desire disorder in premenopausal women. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. And then, meta-analysis was performed using RevMan 5.3 software. Results A total of 4 RCTs involving 3 881 patients were included. The results of meta-analysis showed that： compared with the placebo group, the flibanserin group was superior in increasing the number of satisfying sexual events （SSE） （MD=0.72, 95%CI 0.51 to 0.92, P〈0.000 01）, improving the eDiary desire score （MD=2.21, 95%CI 1.45 to 2.97, P〈0.000 01）, FSFI domain score （MD=0.29, 95%CI 0.24 to 0.35, P〈0.01） and FSFI total score （MD=1.82, 95%CI 1.47 to 2.17, P〈0.000 01）, and decreasing the FSDS-R item 13 score （MD= -0.24, 95%CI -0.31 to -0.17, P〈0.000 01） and FSDS-R total score （MD=-2.70, 95%CI -3.43 to -1.96, P〈0.000 01）. However, the incidence of adverse events in the flibanserin group was higher than that of the placebo group （OR=1.31, 95%CI 1.11 to 1.54, P=0.001）. Conclusion The current evidence suggests that, in premenopausal women with HSDD, flibanserin treatment is effective but may increase the incidence of adverse events.