米拉贝隆对比索利那新治疗膀胱过度活动症的临床研究  

A clinical study of mirabegron versus solifenacin for the treatment of overactive bladder

作　　者：刘泽林 翟官忠 王清华 柯帅 郭佳[1] Liu Zelin;Zhai Guanzhong;Wang Qinghua;Ke Shuai;Guo Jia(Department of Urology,Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院泌尿外科,430060

出　　处：《中华实验外科杂志》2020年第12期2199-2202,共4页Chinese Journal of Experimental Surgery

基　　金：国家自然科学基金青年基金(81702539)。

摘　　要：目的探讨米拉贝隆单药或联合索利那新对比单药索利那新治疗膀胱过度活动症(OAB)患者的有效性及安全性。方法筛选武汉大学人民医院泌尿外科2018年1月至2020年1月诊断为OAB患者90例纳入本研究。采用随机数表法按照1∶1∶1的比例将患者分为A、B和C组,每组30例。A组单用米拉贝隆(50 mg,1次/d);B组单用索利那新(5 mg,1次/d);C组同时服用米拉贝隆和索利那新,剂量同A、B组。在基线和治疗第4、8和12周后,对患者进行复诊及随访,比较3组平均24 h急迫性尿失禁次数、平均24 h尿急次数、平均24 h排尿次数、每晚平均夜尿次数、膀胱过度活动症症状评分(OABSS)以及药物相关不良事件发生率。组间及组内数据均值的多重两两比较采用基于方差分析的Dunnett-t检验。结果共获得82例(91.11%)OAB患者的可靠随访数据,平均年龄51(26~80)岁,74例(90.24%)为女性。3组患者治疗后较前均显著改善(P<0.05);与单药治疗比较,C组(联合用药组)在尿急次数、夜尿次数、OABSS方面显著改善,差异有统计学意义(P<0.05)。3组患者均未发生严重不良事件,27例(32.9%)患者出现≥1次不良事件;口干是最常见的不良事件(米拉贝隆:7.14%;索利那新:11.54%;联合用药:10.71%)。结论米拉贝隆和索利那新治疗OAB有效且安全,其两者治疗效果相当;联合用药在不增加药物相关不良反应的前提下,治疗效果更优。Objective To investigate the effectiveness and safety of mirabegron single or combined with solifenacin in patients with overactive bladder(OAB).Methods From January 2018 to January 2020,90 patients diagnosed as OAB in the urology department of Renmin Hospital of Wuhan University were selected and included in this study.Patients were divided into A,B and C groups with 30 patients in each group according to the method of random number table in 1∶1∶1 ratio.Group A was treated with mirabegron alone(50 mg,1 time/day).Solifenacin was used only in group B(5 mg,1 time/day).Group C received mirabegron and solifenacin at the same dose as groups A and B.At baseline and 4,8 and 12 weeks after treatment,to visit and follow-up patients,the daily urgency incontinence frequency,urgency frequency,urination frequency,nocturnal urination frequency,OAB symptom score(OABSS)and the incidence of drug-related adverse events of the 3 groups were compared.Dunnett-t test was used for multiple pairwise comparisons of data mean between groups.Results Reliable follow-up data were obtained for 82(91.11%)OAB patients with an average age of 51(26-80)years and 74(90.24%)females.After treatment,patients in the three groups were significantly improved(P<0.05).Compared with single drug treatment,patients in group C(combined drug group)were significantly improved in terms of urgency frequency,nocturnal urination frequency,and OABSS,with statistical significance(P<0.05).No serious adverse events occurred in the three treatment groups,and 27 patients(32.9%)had≥1 adverse event.Dry mouth is the most common adverse event(mirabegron,7.14%;solifenacin,11.54%;combination 10.71%).Conclusion The treatments of mirabegron and solifenacin for OAB were effective and safe,with comparable efficacy;the combination of drugs is more effective without increasing drug-related adverse reactions.

关 键 词：膀胱 过度活动症 米拉贝隆 索利那新 临床研究 联合治疗 

分 类 号：R694[医药卫生—泌尿科学]