Rackley Raymond, Weiss Jeffrey P, Rovner Eric S, Wang Joseph T, Guan Zhonghong
Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
Urology. 2006 Apr;67(4):731-6; discussion 736. doi: 10.1016/j.urology.2005.10.061.
To evaluate the efficacy and tolerability of nighttime tolterodine dosing on urgency-related micturitions in patients with overactive bladder (OAB) and nocturia.
This was a 12-week randomized controlled study of 850 patients given 4 mg tolterodine extended release (TER) or placebo once daily 4 hours or less before bed. Patients with eight or more micturitions/24 hours and a mean of 2.5 episodes/night or more were included. Changes in the number of nighttime and 24-hour micturitions were analyzed by urgency rating per micturition. The urgency per micturition was recorded in 7-day diaries using a 5-point rating scale (score 1 to 5). Each micturition was classified according to the following urgency rating categories: total (1 to 5), non-OAB (1 to 2), or OAB (3 to 5). OAB-related micturitions were further classified as nonsevere (score 3) and severe (score 4 to 5).
TER reduced the total number of nocturnal micturitions, but, compared with placebo, this difference was not statistically significant. However, TER did significantly reduce OAB-related and severe OAB-related nocturnal micturitions compared with placebo. TER had no effect on non-OAB micturitions. TER significantly reduced the total, OAB, and severe OAB micturitions during 24-hour and daytime intervals compared with placebo. Significantly more TER-treated than placebo-treated patients reported a treatment benefit and willingness to continue treatment. Adverse events associated with nighttime dosing of TER versus placebo were few.
TER significantly reduced OAB-related micturitions during 24-hour, daytime, and nighttime intervals. TER did not affect normal (non-OAB) micturitions. Nighttime dosing with TER was associated with few adverse events and adverse event-related withdrawals. The 24-hour efficacy of TER was maintained with nighttime dosing.
评估夜间服用托特罗定对膀胱过度活动症（OAB）和夜尿症患者尿急相关排尿次数的疗效和耐受性。
这是一项为期12周的随机对照研究，850例患者在睡前4小时或更短时间内每日一次服用4毫克托特罗定缓释片（TER）或安慰剂。纳入标准为24小时排尿次数达8次或更多且平均每晚发作2.5次或更多的患者。根据每次排尿的尿急程度评分分析夜间及24小时排尿次数的变化。使用5分制评分量表（1至5分）在7天日记中记录每次排尿的尿急程度。每次排尿根据以下尿急程度类别进行分类：总计（1至5分）、非OAB（1至2分）或OAB（3至5分）。与OAB相关的排尿进一步分为非严重（3分）和严重（4至5分）。
TER减少了夜间排尿的总数，但与安慰剂相比，这种差异无统计学意义。然而，与安慰剂相比，TER确实显著减少了与OAB相关及严重OAB相关的夜间排尿次数。TER对非OAB排尿无影响。与安慰剂相比，TER在24小时及白天期间显著减少了总计、OAB及严重OAB排尿次数。报告治疗有益且愿意继续治疗的接受TER治疗的患者明显多于接受安慰剂治疗的患者。与夜间服用TER和安慰剂相关的不良事件很少。
TER在24小时、白天及夜间期间显著减少了与OAB相关的排尿次数。TER不影响正常（非OAB）排尿。夜间服用TER不良事件及与不良事件相关的停药很少。TER的24小时疗效通过夜间给药得以维持。
