Department of Urology, Vanderbilt University School of Medicine, Nashville, TN 37232, USA.
Value Health. 2010 Mar-Apr;13(2):251-7. doi: 10.1111/j.1524-4733.2009.00652.x. Epub 2009 Oct 8.
Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine trospium chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with trospium chloride ER 60 mg were analyzed.
Subjects aged>or=18 years with urinary urgency, frequency, and an average of >or=1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q).
Overall, 1165 subjects were randomized (trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with trospium ER than with placebo (+25.8 vs. +20.7; P=0.0003). Improvements from baseline were seen with trospium ER on all eight of the OAB-q symptom bother scales.
Once-daily trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.
膀胱过度活动症（OAB）是一种经常对个人生活质量（QoL）产生不利影响的泌尿系统疾病。最近开发了一种每日一次的季铵盐托特罗定的延长释放（ER）制剂，用于治疗 OAB。对两项多中心、平行组、双盲 III 期研究中托特罗定 ER 60mg 的汇总健康相关生活质量（HRQoL）数据进行了分析。
年龄>或=18 岁、有尿意急迫、频尿、3 天排尿日记中平均每天有>或=1 次急迫性尿失禁发作的患者，按 1:1 随机分为每日一次托特罗定 60mg ER 或安慰剂治疗 12 周。使用 King's 健康问卷（KHQ）和 OAB 问卷（OAB-q）在基线和第 12 周评估 HRQoL。
共有 1165 名患者随机分组（托特罗定 ER，n=578；安慰剂，n=587）。托特罗定 ER 在九个 KHQ 领域中的七个领域均较安慰剂有显著改善。在第 12 周，OAB-q HRQoL 总分（约基线时为 52）的改善明显大于安慰剂（+25.8 vs.+20.7；P=0.0003）。托特罗定 ER 在 OAB-q 的所有 8 个症状困扰量表中都有改善。
在两项大型 III 期临床试验中，每日一次托特罗定 60mg ER 改善了 OAB 患者的生活质量，这可通过 KHQ 和 OAB-q 评估。
