Cardozo Linda, Hessdörfer Elke, Milani Rodolfo, Arañó Pedro, Dewilde Luc, Slack Mark, Drogendijk Ted, Wright Mark, Bolodeoku John
King's College Hospital, Department of Urogynaecology, London, UK.
BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.
To examine the effects of the antimuscarinic agent solifenacin on urinary urgency, using a range of novel and established outcome measures, as urgency is the principal symptom of the overactive bladder syndrome (OAB).
The study (SUNRISE, solifenacin in the treatment of urgency symptoms of OAB in a rising dose, randomized, placebo-controlled, double-blind, efficacy trial) was a randomized, double-blind, 16-week, placebo-controlled, multicentre study of solifenacin 5/10 mg in 863 patients with symptoms of OAB for > or = 3 months. The primary efficacy variable was the change from baseline to endpoint in the number of episodes of severe urgency with or without urgency incontinence per 24 h, as measured using the Patient Perception of Intensity of Urgency Scale, grade 3 + 4. Secondary efficacy variables included patient-reported outcomes for bladder condition, urgency bother and treatment satisfaction. A 3-day voiding diary was used to record micturition frequency and episodes of urgency and incontinence. A 7-day diary was used to assess speed of onset of effect.
Solifenacin 5/10 mg was significantly more effective than placebo in reducing the mean number of episodes of severe urgency with or without incontinence per 24 h from baseline to endpoint (-2.6 vs -1.8, P < 0.001). There were also statistically significant differences in favour of solifenacin 5/10 mg over placebo for all secondary variables measured at endpoint, including patient-reported outcomes. There was a significant improvement in urgency as early as day 3 of treatment. Treatmente-mergent adverse events with solifenacin 5/10 mg were mainly mild or moderate in severity, and only led to discontinuation in 3.6% of patients.
Solifenacin significantly reduced the number of urgency episodes and the extent of urgency bother, and was well tolerated; it was effective as early as day 3 of treatment.
使用一系列新的和既定的结局指标，研究抗毒蕈碱药物索利那新对尿急的影响，因为尿急是膀胱过度活动症（OAB）的主要症状。
该研究（SUNRISE，索利那新治疗OAB尿急症状的递增剂量、随机、安慰剂对照、双盲、疗效试验）是一项随机、双盲、为期16周、安慰剂对照、多中心研究，纳入863例有OAB症状≥3个月的患者，给予索利那新5/10mg。主要疗效变量是使用患者尿急强度感知量表3 + 4级测量的每24小时有或无尿急失禁的严重尿急发作次数从基线到终点的变化。次要疗效变量包括患者报告的膀胱状况、尿急困扰和治疗满意度结果。使用3天排尿日记记录排尿频率、尿急和失禁发作情况。使用7天日记评估起效速度。
从基线到终点，索利那新5/10mg在减少每24小时有或无失禁的严重尿急发作平均次数方面显著优于安慰剂（-2.6对-1.8，P < 0.001）。在终点测量的所有次要变量方面，索利那新5/10mg也显著优于安慰剂，包括患者报告的结果。治疗第3天尿急就有显著改善。索利那新5/10mg治疗出现的不良事件主要为轻度或中度，仅3.6%的患者因不良事件停药。
索利那新显著减少尿急发作次数和尿急困扰程度，耐受性良好；治疗第3天即有效。
