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评估索利那新治疗效果的III期试验汇总分析中,膀胱过度活动症相关尿失禁的减少情况。

Reductions in overactive bladder-related incontinence from pooled analysis of phase III trials evaluating treatment with solifenacin.

作者信息

Cardozo Linda, Castro-Diaz David, Gittelman Marc, Ridder Arwin, Huang Moses

机构信息

Department of Urogynaecology, King's College Hospital, London, W1G 6HP, UK.

出版信息

Int Urogynecol J Pelvic Floor Dysfunct. 2006 Sep;17(5):512-9. doi: 10.1007/s00192-005-0058-6. Epub 2006 Apr 20.

DOI:10.1007/s00192-005-0058-6
PMID:16625311
Abstract

The embarrassment and social stigma associated with urinary incontinence (UI) in overactive bladder syndrome (OAB) sufferers is a major reason for individuals to seek help for their condition. An analysis of 1,873 subjects with OAB with UI was conducted to assess the efficacy of solifenacin in reducing incontinence in a pooled population from four phase III clinical trials, stratified by severity of incontinence, urgency, and other key factors at baseline. Subjects were randomized to either 5 or 10 mg of solifenacin once daily or placebo for 12 weeks. More than 50% of the total population became continent at study end, with either dose of solifenacin (P<0.01 vs placebo). Significant reductions in incontinence episodes and higher rates of attainment of continence vs placebo were observed irrespective of age or severity of incontinence or urgency at baseline with solifenacin treatment. Treatment was well tolerated, with the majority of adverse events being mild in nature. Solifenacin is an effective antimuscarinic agent for the treatment of incontinence associated with OAB.

摘要

膀胱过度活动症(OAB)患者中与尿失禁(UI)相关的尴尬和社会耻辱感是个人寻求治疗其病情帮助的主要原因。对1873名患有OAB合并UI的受试者进行了一项分析,以评估索利那新在减少尿失禁方面的疗效,该分析来自四项III期临床试验的汇总人群,根据基线时尿失禁的严重程度、尿急程度和其他关键因素进行分层。受试者被随机分为每日一次服用5毫克或10毫克索利那新或安慰剂,为期12周。在研究结束时,超过50%的总人群使用任一剂量的索利那新后实现了控尿(与安慰剂相比,P<0.01)。无论年龄、基线时尿失禁或尿急的严重程度如何,索利那新治疗均观察到尿失禁发作次数显著减少,且与安慰剂相比控尿率更高。治疗耐受性良好,大多数不良事件性质轻微。索利那新是一种治疗与OAB相关尿失禁的有效抗毒蕈碱药物。

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