Hsu Frances C, Weeks Chandler E, Selph Shelley S, Blazina Ian, Holmes Rebecca S, McDonagh Marian S
Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.
Pacific Northwest Evidence-based Practice Center, Portland, OR, USA.
Int Urogynecol J. 2019 Oct;30(10):1603-1617. doi: 10.1007/s00192-019-04022-8. Epub 2019 Jul 25.
Overactive bladder (OAB) is a common condition, increasing with age and affecting quality of life. While numerous OAB drugs are available, persistence is low. We evaluated evidence published since 2012 to determine if newer drugs provided better efficacy and harm profiles.
We searched MEDLINE and the Cochrane Library from 2012 to September 2018 using terms for included drugs and requested information from manufacturers of included drugs. We performed dual review of all systematic review processes, evaluated study quality, and conducted meta-analyses using random effects models.
In addition to 31 older studies, we included 20 trials published since 2012 (N = 16,478; 4 good, 11 fair, and 5 poor quality). Where statistical differences were found, they were clinically small (reductions of < 0.5 episodes/day). Solifenacin plus mirabegron improved efficacy outcomes over monotherapy with either drug, but significantly increased constipation compared with solifenacin and dry mouth compared with mirabegron. Solifenacin reduced incontinence over mirabegron and tolterodine and urgency episodes over tolterodine. Mirabegron did not differ from tolterodine in efficacy but had significantly lower incidence of dry mouth than solifenacin or tolterodine. Fesoterodine showed significant improvements but also anticholinergic effects vs. tolterodine. Oxybutynin, solifenacin, and tolterodine had similar efficacy, but dry mouth led to greater discontinuation with oxybutynin. Blurred vision, cardiac arrhythmia, and dizziness were uncommon.
New evidence confirms small, but clinically uncertain, differences among monotherapies and also between combination and monotherapy, regardless of statistical significance. While drugs mainly differed in incidence of dry mouth or constipation, none provided improved efficacy without increased harms.
膀胱过度活动症(OAB)是一种常见病症,其发病率随年龄增长而增加,并影响生活质量。虽然有多种OAB药物可供使用,但药物持久性较低。我们评估了自2012年以来发表的证据,以确定新型药物是否具有更好的疗效和安全性。
我们检索了2012年至2018年9月期间的MEDLINE和Cochrane图书馆,使用纳入药物的检索词,并向纳入药物的制造商索取信息。我们对所有系统评价过程进行了双人评审,评估了研究质量,并使用随机效应模型进行了荟萃分析。
除了31项较早的研究外,我们还纳入了2012年以来发表的20项试验(N = 16,478;4项质量良好,11项质量一般,5项质量较差)。在发现有统计学差异的地方,临床差异较小(每天发作次数减少<0.5次)。索利那新联合米拉贝隆比单一药物治疗的疗效更好,但与索利那新相比便秘显著增加,与米拉贝隆相比口干显著增加。索利那新比米拉贝隆和托特罗定更能减少尿失禁,比托特罗定更能减少尿急发作次数。米拉贝隆与托特罗定在疗效上无差异,但口干发生率明显低于索利那新或托特罗定。非索罗定与托特罗定相比有显著改善,但也有抗胆碱能作用。奥昔布宁、索利那新和托特罗定疗效相似,但口干导致奥昔布宁停药率更高。视力模糊、心律失常和头晕并不常见。
新证据证实,单一疗法之间以及联合疗法与单一疗法之间存在微小但临床意义不确定的差异,无论统计学意义如何。虽然药物主要在口干或便秘发生率上有所不同,但没有一种药物在不增加危害的情况下提高疗效。