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索利那新用于膀胱过度活动症

Solifenacin in overactive bladder syndrome.

作者信息

Simpson Dene, Wagstaff Antona J

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

Drugs Aging. 2005;22(12):1061-9. doi: 10.2165/00002512-200522120-00005.

Abstract

Solifenacin is a bladder-selective, muscarinic (M(1) and M(3)) receptor antagonist. In animal studies, the selectivity of solifenacin for the bladder over the salivary glands was greater than that of tolterodine, oxybutynin, darifenacin or atropine. In large, 12-week, randomised, double-blind, multicentre clinical trials, solifenacin 5 and 10mg once daily improved symptoms of overactive bladder syndrome (OAB) [urinary urgency, frequency, incontinence and nocturia] and increased functional bladder capacity to a significantly greater extent than placebo. Solifenacin 5 or 10mg once daily was noninferior to tolterodine extended release (ER) 4mg daily for improving urinary frequency and had significantly greater efficacy than tolterodine ER for improving other symptoms of OAB (episodes of urgency, incontinence and urge incontinence) and increasing functional bladder capacity. At least half of all patients receiving solifenacin who were incontinent at baseline were continent by study end in the three comparative studies reporting this parameter. Health-related quality of life was significantly improved with once-daily solifenacin 5 or 10mg versus placebo, as assessed in two 12-week double-blind studies; the improvement was maintained during a 40-week extension study. Solifenacin was generally well tolerated; the most frequently reported adverse events were dry mouth, constipation and blurred vision.

摘要

索利那新是一种膀胱选择性毒蕈碱(M(1)和M(3))受体拮抗剂。在动物研究中,索利那新对膀胱相对于唾液腺的选择性高于托特罗定、奥昔布宁、达非那新或阿托品。在大规模、为期12周的随机、双盲、多中心临床试验中,每日一次服用5毫克和10毫克索利那新改善了膀胱过度活动症(OAB)的症状[尿急、尿频、尿失禁和夜尿症],并使功能性膀胱容量增加,其程度显著大于安慰剂。每日一次服用5毫克或10毫克索利那新在改善尿频方面不劣于每日4毫克托特罗定缓释片(ER),且在改善OAB的其他症状(尿急发作、尿失禁和急迫性尿失禁)以及增加功能性膀胱容量方面比托特罗定ER具有显著更高的疗效。在三项报告了该参数的比较研究中,至少一半在基线时存在尿失禁的接受索利那新治疗的患者在研究结束时实现了控尿。在两项为期12周的双盲研究中评估发现,与安慰剂相比,每日一次服用5毫克或10毫克索利那新可显著改善健康相关生活质量;在一项为期40周的延长期研究中,这种改善得以维持。索利那新总体耐受性良好;最常报告的不良事件为口干、便秘和视力模糊。

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