米拉贝隆治疗膀胱活动过度症的荟萃分析

Meta-analysis of Mirabegron in the treatment of overactive bladder

目的评价米拉贝隆治疗膀胱活动过度症(OAB)的临床作用。本文通过系统综述和荟萃分析评价药物治疗OAB的有效性和安全性。方法回顾文献,筛选出所有已发表的、使用米拉贝隆治疗OAB的随机、双盲、安慰剂对照Ⅲ期试验。检索数据库包括:Medline、Embase和Cochrane对照试验注册库。检索所得文献的参考文献也一并纳入分析。在此基础上进行Ⅲ期试验的系统综述和荟萃分析。结果对已发表的5项研究所纳入的5 761例患者进行了分析,其中包含4项对比米拉贝隆和安慰剂的Ⅲ期RCT。本项荟萃分析的结果显示米拉贝隆可有效治疗OAB。共同主要有效性终点:24h的尿失禁平均次数[标准平均差(SMD)]=-0.44,95%置信区间(CI)-0.59^-0.29,P<0.000 01);24h的平均排尿次数(SMD=-0.62,95%CI-0.80^-0.45,P<0.000 01)和关键次要有效性终点:每次排尿的平均排出量;24h的尿急平均次数的结果均表明米拉贝隆优效于安慰剂。安全性评估内容包括常见的治疗中出现的不良事件(TEAE)(OR=1.07,95%CI0.92~1.25,P=0.39),高血压、心律失常、尿潴留以及因不良事件导致停药,结果表明米拉贝隆耐受良好。结论本荟萃分析表明,米拉贝隆用于OAB对症治疗安全有效,副反应发生率低。该药是一种能够有效治疗OAB的口服药物,具有有效性与耐受性均衡的特性。

Objective To evaluate the efficacy and safety of Mirabegron for the treatment of overactive bladder（OAB）with a systematic review and meta-analysis.Methods All published randomized double-blind,placebo and controlled trials（RCT）to treat OAB with Mirabegron were searched in databases of Medline,Embase,and Cochrane Controlled Trials Register.The reference lists of the retrieved studies were also investigated.A systematic review and Meta-analysis were conducted.Results A total of 5 studies with 5 761 patients were involved,including 4 phase Ⅲ RCTs that compared Mirabegron with placebo.Mirabegron was effective in treating OAB.Co-primary efficacy end points：the mean number of incontinence episodes per 24 h（SMD=-0.44,95% CI=-0.59-0.29,P〈0.000 01）;the mean number of micturitions per 24 h（SMD=-0.62,95%CI=-0.80--0.45,P〈0.000 01）.Key secondary efficacy end points：mean volume voided per micturition;mean number of urgency episodes per 24 h indicated that Mirabegron was more effective than placebo.Safety assessment included common TEAEs（treatment-emergent adverse events）（OR=1.07,95 % CI 0.92-1.25,P=0.39）.Hypertension,cardiac arrhythmia TEAEs,urinary retention and discontinuations due to adverse event indicated that Mirabegron was well tolerated.Conclusions Mirabegron is effective and safe to treat overactive bladder,with few side effects and good tolerability.