非索罗定治疗膀胱过度活动症女性患者的疗效和耐受性
Efficacy and tolerability of fesoterodine in women with overactive bladder.
作者信息
Sand Peter K, Morrow Jon D, Bavendam Tamara, Creanga Dana L, Nitti Victor W
机构信息
Evanston Continence Center, Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, 1000 Central Street, Suite 730, Evanston, IL 60201, USA.
出版信息
Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):827-35. doi: 10.1007/s00192-009-0857-2. Epub 2009 Mar 17.
INTRODUCTION AND HYPOTHESIS
We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB).
METHODS
This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12.
RESULTS
By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predominately mild or moderate.
CONCLUSIONS
Fesoterodine is efficacious and well tolerated in women with OAB.
引言与假设
我们评估了非索罗定对膀胱过度活动症（OAB）女性患者的疗效和耐受性。
方法
这项对两项临床试验汇总数据的事后分析纳入了1548例OAB女性患者，她们被随机分配接受安慰剂、4毫克或8毫克非索罗定，或在一项试验中接受4毫克缓释托特罗定治疗，为期12周。受试者在基线、第2周和第12周完成3天的膀胱日记，并在第2周和第12周对治疗反应进行评分。
结果
到第2周和第12周时，所有积极治疗组在所有评估的五个膀胱日记变量方面均显示出显著改善，且治疗反应率高于安慰剂组。在改善急迫性尿失禁发作次数和每周无尿失禁天数方面，8毫克非索罗定比4毫克非索罗定和缓释托特罗定显著更有效。最常见的不良事件是口干和便秘，大多为轻度或中度。
结论
非索罗定对OAB女性患者有效且耐受性良好。
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