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非索罗定治疗膀胱过度活动症的临床疗效及安全性与患者特征的关系:一项系统评价

Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review.

作者信息

Chapple Christopher, Oelke Matthias, Kaplan Steven A, Scholfield David, Arumi Daniel, Wagg Adrian S

机构信息

The Royal Hallamshire Hospital , Sheffield , United Kingdom.

出版信息

Curr Med Res Opin. 2015 Jun;31(6):1201-43. doi: 10.1185/03007995.2015.1032917. Epub 2015 Apr 23.

DOI:10.1185/03007995.2015.1032917
PMID:25798911
Abstract

OBJECTIVE

To summarize published evidence on the pharmacology, efficacy, and safety of fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles.

METHODS

A systematic review of published articles on fesoterodine was conducted via a PubMed search. Articles were identified using the search term fesoterodine, with limits of human species and abstract available. Review and meta-analysis articles, validation studies, articles focused on treatment compliance/adherence, meeting abstracts, and articles not focused on oral fesoterodine administration in human subjects were excluded. Data from retained articles were summarized descriptively.

RESULTS

Of 137 articles identified, 61 (15 articles on the pharmacology and 46 articles on the efficacy and/or safety of fesoterodine) met inclusion criteria. Superiority trials demonstrated the additional efficacy of fesoterodine 8 mg versus fesoterodine 4 mg and tolterodine extended release 4 mg in treating OAB. Prospective trials in specific patient populations indicated beneficial effects of fesoterodine in elderly patients, vulnerable elderly patients, patients dissatisfied with or with a suboptimal response to previous antimuscarinic therapy, patients with urge urinary incontinence (UUI) or nocturnal urgency, and men with persistent LUTS during alpha-blocker treatment. With two effective doses, the fesoterodine dose can be adjusted to achieve optimal efficacy and tolerability in individual patients. The most common adverse events during fesoterodine treatment are dry mouth and constipation.

CONCLUSIONS

Extensive evidence demonstrates the efficacy and safety of fesoterodine in relieving OAB symptoms, including urgency, urinary frequency, UUI, and nocturnal urgency, in patients with various clinical and demographic profiles. Trial results provide valuable information on fesoterodine treatment in specific patient populations, including both elderly and vulnerable elderly patients. Potential limitations of this review are that only English language articles in PubMed were searched and included.

摘要

目的

总结已发表的关于非索罗定治疗膀胱过度活动症(OAB)症状的药理学、疗效和安全性的证据,及其与患者临床和人口统计学特征的关系。

方法

通过PubMed搜索对已发表的关于非索罗定的文章进行系统评价。使用搜索词“非索罗定”识别文章,并限定为人类研究且有摘要。排除综述和荟萃分析文章、验证研究、关注治疗依从性/持续性的文章、会议摘要以及未关注人类受试者口服非索罗定给药的文章。对纳入文章的数据进行描述性总结。

结果

在识别出的137篇文章中,61篇(15篇关于非索罗定的药理学,46篇关于非索罗定的疗效和/或安全性)符合纳入标准。优效性试验表明,8毫克非索罗定在治疗OAB方面比4毫克非索罗定和4毫克托特罗定缓释剂更有效。特定患者群体的前瞻性试验表明,非索罗定对老年患者、脆弱老年患者、对先前抗毒蕈碱治疗不满意或反应欠佳的患者、急迫性尿失禁(UUI)或夜间尿急患者以及在α受体阻滞剂治疗期间持续存在下尿路症状(LUTS)的男性患者有有益作用。有两种有效剂量,可调整非索罗定剂量以在个体患者中实现最佳疗效和耐受性。非索罗定治疗期间最常见的不良事件是口干和便秘。

结论

大量证据表明非索罗定在缓解不同临床和人口统计学特征患者的OAB症状(包括尿急、尿频、UUI和夜间尿急)方面具有疗效和安全性。试验结果为特定患者群体(包括老年和脆弱老年患者)的非索罗定治疗提供了有价值的信息。本综述的潜在局限性在于仅检索并纳入了PubMed中的英文文章。

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