Kaplan Steven A, Roehrborn Claus G, Dmochowski Roger, Rovner Eric S, Wang Joseph T, Guan Zhonghong
Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, New York 10021, USA.
Urology. 2006 Aug;68(2):328-32. doi: 10.1016/j.urology.2006.03.006.
To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release (TER) in men with overactive bladder (OAB) and nocturia.
This was a post hoc analysis of data from two 12-week, double-blind, placebo-controlled trials of nighttime (<4 hours before bedtime) TER (4 mg daily) dosing. Men with a mean micturition frequency of eight or more times in 24 hours, including a mean of 2.5 or more nocturia episodes/night, were included. For each micturition, patients used 7-day diaries to record urinary urgency on a 5-point urgency rating scale (1, none; 2, mild; 3, moderate; 4, severe; 5, urgency urinary incontinence). Micturitions were analyzed post hoc by urgency rating categories: total (1 to 5), non-OAB (1 to 2), OAB (3 to 5), and severe OAB (4 to 5). Adverse events were recorded throughout the study.
A total of 745 men (mean age 64 years) were randomized to placebo (n = 374) or TER (n = 371). Of the 745 men, 73% reported no incontinence episodes in a 7-day diary at baseline. At week 12, the weekly values for nighttime severe OAB micturitions and 24-hour and daytime total, OAB, and severe OAB micturitions were significantly reduced in the TER group versus the placebo group. The TER-treated men also reported a significant reduction in the mean urgency rating versus placebo. Adverse events associated with TER were low and comparable to those in the placebo group, with the exception of dry mouth (11% versus 4%). Withdrawals because of adverse events were infrequent (3% TER, 4% placebo). Five men were withdrawn for symptoms suggestive of urinary retention (3 TER, 2 placebo).
Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia.
评估托特罗定缓释片（TER）夜间给药对膀胱过度活动症（OAB）伴夜尿症男性患者的疗效和安全性。
这是一项对两项为期12周的双盲、安慰剂对照试验数据的事后分析，试验为夜间（就寝前<4小时）服用TER（每日4毫克）。纳入24小时平均排尿频率为8次或更多，包括平均每晚夜尿发作2.5次或更多的男性。对于每次排尿，患者使用7天日记，根据5分尿急评分量表（1，无；2，轻度；3，中度；4，重度；5，急迫性尿失禁）记录尿急情况。事后按尿急评分类别分析排尿情况：总计（1至5）、非OAB（1至2）、OAB（3至5）和重度OAB（4至5）。在整个研究过程中记录不良事件。
共有745名男性（平均年龄64岁）被随机分为安慰剂组（n = 374）或TER组（n = 371）。在这745名男性中，73%在基线7天日记中报告无尿失禁发作。在第12周时，与安慰剂组相比，TER组夜间重度OAB排尿以及24小时和白天总计、OAB和重度OAB排尿的每周值显著降低。接受TER治疗的男性报告的平均尿急评分也比安慰剂组显著降低。与TER相关的不良事件发生率较低，与安慰剂组相当，但口干除外（11%对4%）。因不良事件而退出的情况很少见（TER组为3%，安慰剂组为4%）。有5名男性因提示尿潴留的症状而退出（TER组3名，安慰剂组2名）。
夜间服用TER可减少与尿急相关的排尿次数，且OAB伴夜尿症男性患者对其耐受性良好。
