Abstract：
OBJECTIVE: Antimuscarinics and the β3-adrenoreceptor agonist, mirabegron, are commonly used for treating patients with overactive bladder (OAB) and α1 -adrenoreceptor antagonists (α1 -blockers) are the main pharmacological agents used for treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). As these conditions commonly occur together, the aim of this systematic review was to identify publications that compared the use of an α1 -blocker plus mirabegron with an α1 -blocker plus antimuscarinic in men with LUTS secondary to BPH and OAB. A meta-analysis was subsequently conducted to explore the safety and efficacy of these combinations.
METHODS: Included records had to be from a parallel-group, randomized clinical trial that was ≥8 weeks in duration. Participants were male with LUTS secondary to BPH and OAB. The indirect analyses that were identified compared an α1 -blocker plus OAB agent with an α1 -blocker plus placebo. The PubMed/Medical Literature Analysis and Retrieval System Online, the Excerpta Medica Database, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched for relevant records up until March 5, 2020. Safety outcomes included incidences of overall treatment-emergent adverse events (TEAEs) and urinary retention, postvoid residual volume, and maximum urinary flow (Qmax ). Primary efficacy outcomes were micturitions/day, incontinence episodes/day, and urgency episodes/day, and secondary outcomes were Overactive Bladder Symptom Score and International Prostate Symptom Score. A Bayesian network meta-analysis approach was used for the meta-analysis.
RESULTS: Out of a total of 1039 records identified, 24 were eligible for inclusion in the meta-analysis. There were no statistically significant differences between the α1 -blocker plus mirabegron and α1 -blocker plus antimuscarinic groups in terms of the comparisons identified for all the safety and efficacy analyses conducted. Numerically superior results were frequently observed for the α1 -blocker plus mirabegron group compared with the α1 -blocker plus antimuscarinic group for the safety parameters, including TEAEs, urinary retention, and Qmax . For some of the efficacy parameters, most notably micturitions/day, numerically superior results were noted for the α1 -blocker plus antimuscarinic group. Inconsistency in reporting and study variability were noted in the included records, which hindered data interpretation.
CONCLUSIONS: This systematic review and meta-analysis showed that an α1 -blocker plus mirabegron and an α1 -blocker plus antimuscarinic have similar safety and efficacy profiles in male patients with LUTS secondary to BPH and OAB. Patients may, therefore, benefit from the use of either combination within the clinical setting.
METHODS: Included records had to be from a parallel-group, randomized clinical trial that was ≥8 weeks in duration. Participants were male with LUTS secondary to BPH and OAB. The indirect analyses that were identified compared an α1 -blocker plus OAB agent with an α1 -blocker plus placebo. The PubMed/Medical Literature Analysis and Retrieval System Online, the Excerpta Medica Database, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched for relevant records up until March 5, 2020. Safety outcomes included incidences of overall treatment-emergent adverse events (TEAEs) and urinary retention, postvoid residual volume, and maximum urinary flow (Qmax ). Primary efficacy outcomes were micturitions/day, incontinence episodes/day, and urgency episodes/day, and secondary outcomes were Overactive Bladder Symptom Score and International Prostate Symptom Score. A Bayesian network meta-analysis approach was used for the meta-analysis.
RESULTS: Out of a total of 1039 records identified, 24 were eligible for inclusion in the meta-analysis. There were no statistically significant differences between the α1 -blocker plus mirabegron and α1 -blocker plus antimuscarinic groups in terms of the comparisons identified for all the safety and efficacy analyses conducted. Numerically superior results were frequently observed for the α1 -blocker plus mirabegron group compared with the α1 -blocker plus antimuscarinic group for the safety parameters, including TEAEs, urinary retention, and Qmax . For some of the efficacy parameters, most notably micturitions/day, numerically superior results were noted for the α1 -blocker plus antimuscarinic group. Inconsistency in reporting and study variability were noted in the included records, which hindered data interpretation.
CONCLUSIONS: This systematic review and meta-analysis showed that an α1 -blocker plus mirabegron and an α1 -blocker plus antimuscarinic have similar safety and efficacy profiles in male patients with LUTS secondary to BPH and OAB. Patients may, therefore, benefit from the use of either combination within the clinical setting.
摘要：
目的：抗毒蕈药和β3-肾上腺素受体激动剂，Mirabegron,通常用于治疗膀胱过度活动症（OAB）患者，而α1-肾上腺素受体拮抗剂（α1-阻断剂）是用于治疗良性前列腺增生（BPH）继发的下尿路症状（LUTS）的主要药物。由于这些情况通常一起发生，本系统综述的目的是确定在BPH和OAB继发的LUTS患者中比较α1-阻滞剂加米拉贝隆与α1-阻滞剂加抗毒蕈碱的应用的出版物.随后进行荟萃分析以探索这些组合的安全性和有效性。
方法：包含的记录必须来自平行组，随机临床试验，持续时间≥8周。参与者为男性，继发于BPH和OAB的LUTS。鉴定的间接分析比较了α1-阻断剂加OAB剂与α1-阻断剂加安慰剂。PubMed/医学文献分析和在线检索系统，摘录医学数据库,Cochrane中央受控试验登记册,并在ClinicalTrials.gov注册表中搜索相关记录，直到2020年3月5日。安全性结果包括总体治疗引起的不良事件（TEAE）和尿潴留的发生率，后空隙残余体积，和最大尿流（Qmax）。主要疗效结果是排尿/天，失禁发作/天,和紧急事件/天，次要结果为膀胱过度活动症症状评分和国际前列腺症状评分。采用贝叶斯网络荟萃分析方法进行荟萃分析。
结果：在确定的1039条记录中，24人符合纳入荟萃分析的条件。就进行的所有安全性和有效性分析所确定的比较而言，α1-阻断剂加米拉贝隆和α1-阻断剂加抗毒蕈碱组之间没有统计学上的显着差异。在安全性参数方面，与α1-阻滞剂加抗毒蕈碱组相比，α1-阻滞剂加米拉贝隆组经常观察到优于数字的结果。包括TEAE,尿潴留,和Qmax。对于一些疗效参数，最值得注意的是排尿/天，α1-受体阻滞剂加抗毒蕈碱组的数值结果优异.纳入的记录中注意到报告和研究变异性的不一致，这阻碍了数据解释。
结论：这项系统评价和荟萃分析显示，在BPH和OAB继发的男性LUTS患者中，α1受体阻滞剂加米拉贝隆和α1受体阻滞剂加抗毒蕈碱具有相似的安全性和有效性。患者可以，因此,受益于在临床环境中使用这两种组合。
方法：包含的记录必须来自平行组，随机临床试验，持续时间≥8周。参与者为男性，继发于BPH和OAB的LUTS。鉴定的间接分析比较了α1-阻断剂加OAB剂与α1-阻断剂加安慰剂。PubMed/医学文献分析和在线检索系统，摘录医学数据库,Cochrane中央受控试验登记册,并在ClinicalTrials.gov注册表中搜索相关记录，直到2020年3月5日。安全性结果包括总体治疗引起的不良事件（TEAE）和尿潴留的发生率，后空隙残余体积，和最大尿流（Qmax）。主要疗效结果是排尿/天，失禁发作/天,和紧急事件/天，次要结果为膀胱过度活动症症状评分和国际前列腺症状评分。采用贝叶斯网络荟萃分析方法进行荟萃分析。
结果：在确定的1039条记录中，24人符合纳入荟萃分析的条件。就进行的所有安全性和有效性分析所确定的比较而言，α1-阻断剂加米拉贝隆和α1-阻断剂加抗毒蕈碱组之间没有统计学上的显着差异。在安全性参数方面，与α1-阻滞剂加抗毒蕈碱组相比，α1-阻滞剂加米拉贝隆组经常观察到优于数字的结果。包括TEAE,尿潴留,和Qmax。对于一些疗效参数，最值得注意的是排尿/天，α1-受体阻滞剂加抗毒蕈碱组的数值结果优异.纳入的记录中注意到报告和研究变异性的不一致，这阻碍了数据解释。
结论：这项系统评价和荟萃分析显示，在BPH和OAB继发的男性LUTS患者中，α1受体阻滞剂加米拉贝隆和α1受体阻滞剂加抗毒蕈碱具有相似的安全性和有效性。患者可以，因此,受益于在临床环境中使用这两种组合。
