Malone-Lee J, Shaffu B, Anand C, Powell C
Department of Medicine, St Pancras Hospital, London, United Kingdom.
J Urol. 2001 May;165(5):1452-6.
We compared the tolerability and clinical efficacy of tolterodine with those of oxybutynin in patients with an overactive bladder using an upward oxybutynin dose titration strategy analogous to that used in routine clinical practice in the United Kingdom and Republic of Ireland.
In a randomized double-blind trial 378 male and female patients 50 years old or older with symptoms of overactive bladder (a urinary frequency of 8 or more voids per 24 hours with urgency and/or urge incontinence, that is 1 or more urge incontinence episodes per 24 hours) received 10 weeks of treatment with 2 mg. tolterodine twice daily/or an initial dose of 2.5 mg. oxybutynin twice daily, increasing to 5 mg. twice daily after 2 weeks of treatment. The main outcome measures were changes in voiding diary variables combined with detailed tolerability-safety assessments.
Patients treated with tolterodine had significantly fewer adverse events (69% versus 81%, p = 0.01), notably dry mouth (37% versus 61%, p <0.0001), as well as a lower incidence of dose reduction (6% versus 25%, p <0.0001) than those in the oxybutynin group. Each agent had comparable efficacy for improving urinary symptoms. Tolterodine and oxybutynin caused a significant decrease (p = 0.0001) in the mean number of voids per 24 hours (-1.7 or -15% and -1.7 or -15%, respectively), urge incontinence episodes per 24 hours (-1.3 or -54% and -1.8 or -62%, respectively) and mean voided volume per void (33 ml. or 22% and 34 ml. or 23%) after 10 weeks of treatment.
Tolterodine is as effective as oxybutynin for improving the symptoms of overactive bladder but it has superior tolerability. The combination of these qualities makes tolterodine the preferred pharmacological therapy for the long-term treatment of this condition.
我们采用类似于英国和爱尔兰共和国常规临床实践中使用的奥昔布宁剂量递增滴定策略,比较了托特罗定与奥昔布宁在膀胱过度活动症患者中的耐受性和临床疗效。
在一项随机双盲试验中,378例年龄在50岁及以上、有膀胱过度活动症症状(每24小时排尿频率达8次或更多,伴有尿急和/或急迫性尿失禁,即每24小时有1次或更多次急迫性尿失禁发作)的男性和女性患者接受了为期10周的治疗,其中一组每天两次服用2毫克托特罗定,另一组初始剂量为每天两次服用2.5毫克奥昔布宁,治疗2周后增至每天两次5毫克。主要观察指标为排尿日记变量的变化以及详细的耐受性-安全性评估。
与奥昔布宁组相比,接受托特罗定治疗的患者不良事件显著更少(69%对81%,p = 0.01),尤其是口干(37%对61%,p <0.0001),且剂量减少的发生率更低(6%对25%,p <0.0001)。两种药物在改善泌尿系统症状方面疗效相当。治疗10周后,托特罗定和奥昔布宁均使每24小时平均排尿次数显著减少(p = 0.0001)(分别减少-1.7次或-15%和-1.7次或-15%),每24小时急迫性尿失禁发作次数显著减少(分别减少-1.3次或-54%和-1.8次或-62%),每次排尿的平均尿量显著增加(分别增加33毫升或22%和34毫升或23%)。
托特罗定在改善膀胱过度活动症症状方面与奥昔布宁效果相当,但耐受性更佳。这些特性使托特罗定成为长期治疗该病症的首选药物疗法。