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非索罗定在随机临床试验中的应用:疗效与安全性的最新系统临床综述

Fesoterodine in randomised clinical trials: an updated systematic clinical review of efficacy and safety.

作者信息

Dell'Utri Chiara, Digesu G Alessandro, Bhide Alka, Khullar Vik

机构信息

Department of Urogynaecology, St. Mary's Hospital, Cambridge Wing, Praed Street, London W1 1NY, United Kingdom.

出版信息

Int Urogynecol J. 2012 Oct;23(10):1337-44. doi: 10.1007/s00192-012-1696-0. Epub 2012 Mar 13.

DOI:10.1007/s00192-012-1696-0
PMID:22411206
Abstract

INTRODUCTION AND HYPOTHESIS

This is a systematic review of clinical data assessing the safety, efficacy and tolerability of fesoterodine in randomised control trials (RCTs) in the treatment of overactive bladder (OAB).

METHODS

We performed a MEDLINE literature search of articles published between 2005 and 2010 regarding the efficacy and safety of fesoterodine. The US Food and Drug Administration Web site was also searched for RCTs.

RESULTS

Two studies demonstrated significant improvement of OAB symptoms with fesoterodine compared with placebo. Two phase III studies showed both doses of fesoterodine to be more effective than placebo for most symptoms. Another phase III trial confirmed the superiority of 8 mg fesoterodine compared with tolterodine ER 4 mg. Dry mouth was the commonest side effect.

CONCLUSIONS

Fesoterodine is effective for treating OAB symptoms. Its once-daily dosing regime and the flexibility to increase the dose are appealing factors.

摘要

引言与假设

这是一项对临床数据的系统评价,该数据评估了非索罗定在治疗膀胱过度活动症(OAB)的随机对照试验(RCT)中的安全性、有效性和耐受性。

方法

我们对2005年至2010年间发表的有关非索罗定有效性和安全性的文章进行了MEDLINE文献检索。还在美国食品药品监督管理局网站上搜索了随机对照试验。

结果

两项研究表明,与安慰剂相比,非索罗定可显著改善膀胱过度活动症症状。两项III期研究表明,两种剂量的非索罗定在大多数症状方面均比安慰剂更有效。另一项III期试验证实,8毫克非索罗定比4毫克缓释托特罗定更具优势。口干是最常见的副作用。

结论

非索罗定对治疗膀胱过度活动症症状有效。其每日一次的给药方案以及增加剂量的灵活性是吸引人的因素。

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本文引用的文献

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The psychometric validation of a 1-week recall period for the OAB-q.膀胱过度活动症问卷(OAB-q)1周回忆期的心理测量学验证
Int Urogynecol J. 2011 Dec;22(12):1555-63. doi: 10.1007/s00192-011-1486-0. Epub 2011 Jul 8.
2
Differential profile analysis of urinary cytokines in patients with overactive bladder.膀胱过度活动症患者尿液细胞因子的差异谱分析
Int Urogynecol J. 2011 Aug;22(8):953-61. doi: 10.1007/s00192-011-1401-8. Epub 2011 Apr 13.
3
Antimuscarinics for the treatment of overactive bladder: understanding the role of muscarinic subtype selectivity.
用于治疗膀胱过度活动症的抗毒蕈碱药物:了解毒蕈碱亚型选择性的作用
Int Urogynecol J. 2011 Aug;22(8):907-17. doi: 10.1007/s00192-011-1411-6. Epub 2011 Apr 6.
4
Validity and reliability of patient selected goals as an outcome measure in overactive bladder.患者选择的目标作为膀胱过度活动症结局指标的有效性和可靠性。
Int Urogynecol J. 2011 Jul;22(7):841-7. doi: 10.1007/s00192-011-1360-0. Epub 2011 Jan 29.
5
Women's perspective of botulinum toxin treatment for overactive bladder symptoms.女性对肉毒杆菌毒素治疗膀胱过度活动症症状的看法。
Int Urogynecol J. 2011 Apr;22(4):425-31. doi: 10.1007/s00192-010-1315-x. Epub 2010 Nov 24.
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The prevalence and risk factors of overactive bladder symptoms and its relation to pelvic organ prolapse symptoms in a general female population.普通女性人群中膀胱过度活动症症状的患病率、危险因素及其与盆腔器官脱垂症状的关系。
Int Urogynecol J. 2011 May;22(5):569-75. doi: 10.1007/s00192-010-1323-x. Epub 2010 Nov 23.
7
Superior efficacy of fesoterodine over tolterodine extended release with rapid onset: a prospective, head-to-head, placebo-controlled trial.非索罗定控释片较托特罗定控释片具有更快起效的卓越疗效:一项前瞻性、头对头、安慰剂对照试验。
BJU Int. 2011 May;107(9):1432-40. doi: 10.1111/j.1464-410X.2010.09640.x. Epub 2010 Sep 21.
8
Thorough QT study of the effect of fesoterodine on cardiac repolarization.非索罗定对心脏复极化影响的全面QT研究。
Int J Clin Pharmacol Ther. 2010 May;48(5):309-18. doi: 10.5414/cpp48309.
9
Effects of hepatic dysfunction on the single-dose pharmacokinetics of fesoterodine.肝功能障碍对非索罗定单剂量药代动力学的影响。
J Clin Pharmacol. 2011 Mar;51(3):397-405. doi: 10.1177/0091270010365547. Epub 2010 Apr 6.
10
A prospective observational study of the effects of treatment with extended-release tolterodine on health-related quality of life of patients suffering overactive bladder syndrome in Sweden.一项关于缓释托特罗定治疗对瑞典膀胱过度活动症患者健康相关生活质量影响的前瞻性观察研究。
Scand J Urol Nephrol. 2010 Apr;44(3):138-46. doi: 10.3109/00365591003709468.