Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions.

Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions.
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DOI:
10.1111/j.1742-1241.2007.01625.x
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发表时间:
2008-01
影响因子:
2.6
通讯作者:
Zinner, N. R.
Zinner, N. R.
中科院分区:
医学4区
文献类型:
--
作者:
Staskin, D. R.;Rosenberg, M. T.;Dahl, N. V.;Polishuk, P. V.;Zinner, N. R.

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膀胱过度活动症(OAB)在男性中很常见,可合并良性前列腺增生症(BPH)和梗阻。在一项为期6个月的奥昔布宁透皮系统(Oxy-TDS)治疗开放标签研究中,我们对OAB男性患者的结果进行了亚分析。纳入了广泛的进入标准,以产生具有临床代表性的人群。所有参与者服用Oxy-TDS 3.9 mg/d。通过有效问卷得分的变化来评估疗效,其中包括单项患者对膀胱状况的感知(PPBC)、国王健康问卷(KHQ)和贝克抑郁量表-II(BDI-II)。男性(n=369;平均年龄=69.6岁)报告称他们的膀胱状况导致中度、严重或许多严重问题(PBC≥4)的比例从基线的77.3%改善到随后几个月的38.1-53.6%。从基线到研究结束,KHQ的平均得分在10个领域中有8个显著下降(p≤0.0196),表明与健康相关的生活质量得到了改善。BDI-II评分和12分(与抑郁症的诊断相关)的男性比例从23.9%下降到17.9%(p=0.0055)。有“前列腺问题”史或使用“前列腺增生症药物”的男性(32.2%)的KHQ结构域改变与其他男性相似(p≥0.1016)。大多数男性(76.2%)报告没有与治疗相关的不良事件;两名男性(0.5%)出现轻度尿潴留症状,但都不需要导尿。奥昔布宁透皮系统治疗男性OAB是有效的,耐受性良好,无论有无前列腺病史。对患有和不患有BPH的男性进行联合治疗是一个不断发展的范例。这篇文章提供了重要的安全性数据,来自迄今为止最大规模的研究,在社区使用情况下,抗胆碱类药物通常被使用。这项研究在大量人群中提供了重要的生活质量福利数据。社区使用设计没有采用纳入或排除标准,这些标准将限制初级保健医生在“现实生活”环境中管理药物。
Overactive bladder (OAB) is common in men and may exist concomitantly with benign prostatic hyperplasia (BPH) and obstruction. We present a subanalysis of results from men with OAB in a 6-month, open-label study of treatment with the oxybutynin transdermal system (OXY-TDS). Broad entry criteria were incorporated to yield a clinically representative population. All participants received OXY-TDS 3.9 mg/day. Effectiveness was assessed by changes in scores on validated questionnaires, which included the single-item Patient Perception of Bladder Condition (PPBC), the King's Health Questionnaire (KHQ) and the Beck Depression Inventory-II (BDI-II). The proportion of men (n = 369; mean age = 69.6 years) who reported that their bladder condition caused moderate, severe or many severe problems (PPBC ≥ 4) improved from 77.3% at baseline to 38.1–53.6% in subsequent months. Mean KHQ scores decreased significantly (p ≤ 0.0196) from baseline to study end in eight of 10 domains, indicating improved health-related quality of life. The proportion of men with BDI-II score > 12 (associated with a diagnosis of depression) decreased from 23.9% to 17.9% (p = 0.0055). Men with a history of ‘prostate problems’ or use of ‘BPH medication’ (32.2%) had KHQ domain changes that were similar (p ≥ 0.1016) to those of other men. Most men (76.2%) reported no treatment-related adverse events; two men (0.5%) experienced symptoms of mild urinary retention, but neither required catheterisation. Oxybutynin transdermal system treatment of men with OAB was effective and well tolerated, regardless of history of prostate condition. Combined treatment of men with and without BPH is an evolving paradigm. This article contributes significant safety data, from the largest study to date, in a community use situation, where anticholinergics are commonly used. The study provides significant quality of life benefit data in a large population. The community usage design did not employ inclusion or exclusion criteria that would restrict the primary care physician from administrating the medication in a ‘real life’ setting.
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