Corcos Jaques, Casey Richard, Patrick Allan, Andreou Cal, Miceli Paula C, Reiz Joseph L, Harsanyi Zoltan, Darke Andrew C
Jewish General Hospital, Montreal, QC, Canada.
BJU Int. 2006 Mar;97(3):520-7. doi: 10.1111/j.1464-410X.2005.06031.x.
To assess the efficacy, incidence of dry mouth and overall satisfaction with initial doses of 5, 10 and 15 mg of a new, once-daily, controlled-release (CR) form of oxybutynin for treating urge urinary incontinence (UUI).
Patients who reported urinary incontinence (UI) (one or more episodes/diary) and voiding frequency (eight or more voids/day) or urgency (one or more episodes/diary) during a 2-week baseline were randomized to once-daily 5, 10 or 15 mg CR oxybutynin for 4 weeks. Daily episodes of UI, voids, urgency, adverse events, dry mouth and satisfaction were recorded in a 3-day diary at baseline and after 4 weeks of treatment. In all, 237 patients were randomized and evaluated.
Episodes of UI, voids and urgency were significantly reduced over the study period at all doses. Daily UI episodes were significantly lower with 15 mg/day than 5 and 10 mg/day. Dry mouth symptoms were similar in the 10 and 15 mg/day groups, and higher than in the 5 mg/day group. However, significantly greater overall satisfaction was reported with 15 than 5 mg/day.
There were significant dose-response relationships with CR oxybutynin for both UI episodes and dry mouth. The greatest satisfaction was with 15 mg/day, and the severity of dry mouth was comparable at 10 mg/day, indicating that greater efficacy at the higher dose did not compromise tolerability.
评估每日一次服用5毫克、10毫克和15毫克新型控释（CR）奥昔布宁初始剂量治疗急迫性尿失禁（UUI）的疗效、口干发生率及总体满意度。
在为期2周的基线期报告有尿失禁（UI）（每日1次或更多发作/日记）、排尿频率（每日8次或更多排尿）或尿急（每日1次或更多发作/日记）的患者被随机分配至每日一次服用5毫克、10毫克或15毫克CR奥昔布宁，疗程4周。在基线期及治疗4周后，通过3天日记记录每日的UI发作、排尿、尿急、不良事件、口干及满意度情况。共有237例患者被随机分组并进行评估。
在整个研究期间，所有剂量组的UI发作、排尿及尿急情况均显著减少。每日UI发作次数，15毫克/天组显著低于5毫克/天组和10毫克/天组。10毫克/天组和15毫克/天组的口干症状相似，且高于5毫克/天组。然而，报告15毫克/天组的总体满意度显著高于5毫克/天组。
CR奥昔布宁在UI发作和口干方面均存在显著的剂量反应关系。15毫克/天组的满意度最高，10毫克/天组的口干严重程度相当，表明较高剂量下更大的疗效并未影响耐受性。
