Diokno Ananias C, Appell Rodney A, Sand Peter K, Dmochowski Roger R, Gburek Bernard M, Klimberg Ira W, Kell Sherron H
Department of Urology, William Beaumont Hospital, Royal Oak, Mich 48073, USA.
Mayo Clin Proc. 2003 Jun;78(6):687-95. doi: 10.4065/78.6.687.
To compare the efficacy and tolerability of extended-release formulations of oxybutynin chloride and tolterodine tartrate in women with overactive bladder.
The OPERA (Overactive bladder: Performance of Extended Release Agents) trial was a randomized, double-blind, active-control study performed at 71 US study centers from November 21, 2000, to October 18,2001. Extended-release formulations of oxybutynin at 10 mg/d or tolterodine at 4 mg/d were given for 12 weeks to women with 21 to 60 urge urinary incontinence (UUI) episodes per week and an average of 10 or more voids per 24 hours. Episodes of UUI (primary end point), total (urge and nonurge) incontinence, and micturition were recorded in 24-hour urinary diaries at baseline and at weeks 2, 4, 8, and 12 and compared. Adverse events were also evaluated.
Improvements in weekly UUI episodes were similar for the 790 women who received extended-release formulations of oxybutynin (n = 391) or tolterodine (n = 399). Oxybutynin was significantly more effective than tolterodine in reducing micturition frequency (P = .003), and 23.0% of women taking oxybutynin reported no episodes of urinary incontinence compared with 16.8% of women taking tolterodine (P = .03). Dry mouth, usually mild, was more common with oxybutynin (P = .02). Adverse events were generally mild and occurred at low rates, with both groups having similar discontinuation of treatment due to adverse events.
Reductions in weekly UUI and total incontinence episodes were similar with extended-release formulations of oxybutynin and tolterodine. In the oxybutynin group, micturition frequency was significantly lower, and the percentage of women reporting no urinary incontinence episodes was significantly higher compared with the tolterodine group. Dry mouth was more common with oxybutynin, but tolerability was otherwise comparable, including adverse events involving the central nervous system.
比较氯奥昔布宁缓释制剂和酒石酸托特罗定缓释制剂治疗膀胱过度活动症女性患者的疗效和耐受性。
OPERA（膀胱过度活动症：缓释制剂的疗效）试验是一项随机、双盲、活性对照研究，于2000年11月21日至2001年10月18日在美国71个研究中心开展。给予每周有21至60次急迫性尿失禁（UUI）发作且平均每24小时排尿10次或更多次的女性患者服用10mg/d的奥昔布宁缓释制剂或4mg/d的托特罗定缓释制剂，为期12周。在基线以及第2、4、8和12周时，通过24小时排尿日记记录UUI发作次数（主要终点）、总（急迫性和非急迫性）失禁情况及排尿情况，并进行比较。同时评估不良事件。
790名接受奥昔布宁缓释制剂（n = 391）或托特罗定缓释制剂（n = 399）治疗的女性患者，每周UUI发作次数的改善情况相似。奥昔布宁在降低排尿频率方面显著优于托特罗定（P = 0.003），服用奥昔布宁的女性中有23.0%报告无尿失禁发作，而服用托特罗定的女性中这一比例为16.8%（P = 0.03）。口干通常较轻，在服用奥昔布宁的患者中更常见（P = 0.02）。不良事件一般较轻且发生率较低，两组因不良事件而停药的情况相似。
奥昔布宁缓释制剂和托特罗定缓释制剂在减少每周UUI发作次数和总失禁发作次数方面效果相似。与托特罗定组相比，奥昔布宁组的排尿频率显著更低，报告无尿失禁发作的女性比例显著更高。口干在服用奥昔布宁时更常见，但在其他方面耐受性相当，包括涉及中枢神经系统的不良事件。
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