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米拉贝隆50毫克每日一次,长期治疗可使膀胱过度活动症的中年及老年患者获益最大化:一项对9项II/III期、随机、双盲、平行设计、安慰剂对照、多中心、跨国试验的系统评价和荟萃分析。

Mirabegron 50 mg once daily, long-term treatment maximizes benefit in middle-aged and older people with overactive bladder syndrome: a systematic review and meta-analysis of nine phase II/III, randomized, double-blind, parallel-design, placebo-controlled, multicenter, and multinational trials.

作者信息

Zhang Xiangxiang, Mao Yinhui, Liu Yang, Sun Jilei, Sun Juntao, Pan Chenli, Wang Zhuo, Wei Zhitao, Yang Yong

机构信息

Changchun University of Chinese Medicine, Changchun, China.

Department of Urology, The Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, China.

出版信息

Front Surg. 2024 Aug 26;11:1372175. doi: 10.3389/fsurg.2024.1372175. eCollection 2024.

DOI:10.3389/fsurg.2024.1372175
PMID:39252844
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11381383/
Abstract

The prevalence and severity of overactive bladder increase with age, and mirabegron is an approved treatment for this condition. This meta-analysis systematically evaluated the efficacy and safety of mirabegron compared with placebo for overactive bladder treatment. We searched PubMed and the Cochrane Library (30 October 2023) for relevant articles (source: MEDLINE, EMBASE, ClinicalTrials.gov, ICTRP, CINAHL). We included randomized controlled trials involving adults with overactive bladder syndrome that compared mirabegron with placebo treatment. Data were analyzed according to the Cochrane Handbook for Systematic Reviews of Interventions [Review Manager (computer program) Version 5.4]. Nine parallel-group trials (10 articles) were included. The evaluation included a total of 8,527 adults, including 6,445 women and 2,082 men, of whom 5,726 were White, 2,462 were Asian, and 161 were Black. The mean age of the participants ranged from 53.4 to 60.3 years. This evaluation involved three specifications of mirabegron: 25 mg, 50 mg, and 100 mg. In all trials, patients were enrolled in a 12-week double-blind treatment period, and the dose was once daily. The review of trials found that on average, people taking mirabegron had about 13 ml more volume voided per micturition, five fewer micturitions, and four fewer incontinence episodes every week, with moderate improvements in quality of life. About one in five people taking the drug reported TRAEs. Mirabegron treatment is well tolerated, with the risk of adverse events similar to that of a placebo. For best results, a dose of 50 mg once daily is recommended for long-term use. It is unclear whether any benefits are sustained after treatment discontinuation. : https://www.crd.york.ac.uk/prospero/, PROSPERO (CRD42023430737).

摘要

膀胱过度活动症的患病率和严重程度随年龄增长而增加,米拉贝隆是已获批准用于治疗这种病症的药物。本荟萃分析系统评价了米拉贝隆与安慰剂相比治疗膀胱过度活动症的疗效和安全性。我们检索了PubMed和Cochrane图书馆(2023年10月30日)以查找相关文章(来源:MEDLINE、EMBASE、ClinicalTrials.gov、ICTRP、CINAHL)。我们纳入了涉及膀胱过度活动症综合征成人患者的随机对照试验,这些试验比较了米拉贝隆与安慰剂治疗。数据根据《Cochrane干预措施系统评价手册》[Review Manager(计算机程序)第5.4版]进行分析。纳入了9项平行组试验(10篇文章)。评估共纳入8527名成年人,其中包括6445名女性和2082名男性,其中5726人为白人,2462人为亚洲人,161人为黑人。参与者的平均年龄在53.4至60.3岁之间。该评估涉及米拉贝隆的三种规格:25毫克、50毫克和100毫克。在所有试验中,患者进入为期12周的双盲治疗期,剂量为每日一次。对试验的综述发现,平均而言,服用米拉贝隆的人每次排尿的尿量多约13毫升,每周排尿次数少5次,尿失禁发作次数少4次,生活质量有中度改善。服用该药物的人中约五分之一报告了治疗相关不良事件。米拉贝隆治疗耐受性良好,不良事件风险与安慰剂相似。为获得最佳效果,建议长期每日一次服用50毫克剂量。停药后是否仍有任何益处尚不清楚。: https://www.crd.york.ac.uk/prospero/, PROSPERO(CRD42023430737)

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