托特罗定缓释片与奥昔布宁速释片治疗日本和韩国膀胱过度活动症患者的临床疗效及耐受性：一项随机、安慰剂对照试验
Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial.
作者信息
Homma Y, Paick J S, Lee J G, Kawabe K
机构信息
Department of Urology, Tokyo University, Tokyo, Japan.
出版信息
BJU Int. 2003 Nov;92(7):741-7. doi: 10.1046/j.1464-410x.2003.04468.x.
OBJECTIVE
To compare extended-release (ER) tolterodine and immediate-release (IR) oxybutynin with placebo in Japanese and Korean patients with an overactive bladder (OAB).
PATIENTS AND METHODS
Men and women aged >or= 20 years with symptoms of urinary urgency, urinary frequency (>or= 8 micturitions/24 h), urge incontinence (>or= 5 episodes/week) and symptoms of OAB for >or= 6 months were randomized to double-blind treatment with tolterodine ER 4 mg once daily, oxybutynin IR 3 mg three times daily or placebo for 12 weeks. Efficacy assessments included changes from baseline in numbers of incontinence episodes per week, voids/24 h and mean volume voided/void. Patient perceptions of bladder condition, urgency and treatment benefit were also assessed.
RESULTS
In all, 608 patients were randomized to treatment with tolterodine (240), oxybutynin (246) or placebo (122). More patients prematurely withdrew on oxybutynin (23%) than with tolterodine (10.4%) or placebo (16.4%). After 12 weeks of treatment, the median number of incontinence episodes/week was reduced significantly more in the tolterodine (79%; P= 0.0027) and oxybutynin groups (76.5%; P= 0.0168) than on placebo (46.4%). There were also significantly greater improvements in the number of voids/24 h and volume voided/void with tolterodine and oxybutynin than with placebo. More patients in the tolterodine and oxybutynin than in the placebo groups reported improvements in perceived bladder condition, ability to hold urine and treatment benefit. Patients treated with oxybutynin reported more adverse events than those treated with tolterodine or placebo. Dry mouth was significantly more common with oxybutynin than with tolterodine (53.7% vs. 33.5%; P < 0.001), and occurred in 9.8% of placebo patients.
CONCLUSION
Tolterodine ER has similar efficacy but is better tolerated than oxybutynin IR in Japanese and Korean patients with OAB.
目的
在日本和韩国膀胱过度活动症（OAB）患者中，比较缓释托特罗定、速释奥昔布宁与安慰剂的疗效。
患者与方法
年龄≥20岁、有尿急、尿频（≥8次排尿/24小时）、急迫性尿失禁（≥5次发作/周）症状且OAB症状持续≥6个月的男性和女性，被随机分配接受双盲治疗，分别为每日一次服用4毫克缓释托特罗定、每日三次服用3毫克速释奥昔布宁或安慰剂，疗程为12周。疗效评估包括每周尿失禁发作次数、24小时排尿次数及每次排尿平均尿量较基线的变化。还评估了患者对膀胱状况、尿急及治疗效果的感受。
结果
总共608例患者被随机分配接受托特罗定（240例）、奥昔布宁（246例）或安慰剂（122例）治疗。与托特罗定组（10.4%）或安慰剂组（16.4%）相比，奥昔布宁组更多患者提前退出研究（23%）。治疗12周后，托特罗定组（79%；P = 0.0027）和奥昔布宁组（76.5%；P = 0.0168）每周尿失禁发作次数的中位数较安慰剂组（46.4%）显著减少更多。托特罗定和奥昔布宁组在24小时排尿次数及每次排尿量方面的改善也显著大于安慰剂组。与安慰剂组相比，托特罗定组和奥昔布宁组更多患者报告膀胱状况、憋尿能力及治疗效果有所改善。奥昔布宁治疗的患者报告的不良事件比托特罗定或安慰剂治疗的患者更多。奥昔布宁导致的口干明显比托特罗定更常见（53.7%对33.5%；P < 0.001），安慰剂组患者中口干发生率为9.8%。
结论
在日本和韩国OAB患者中，缓释托特罗定疗效与奥昔布宁相似，但耐受性优于速释奥昔布宁。
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