Mariappan P, Ballantyne Z, N'Dow J M O, Alhasso A A
Department of Urology, Western General Hospital, Crewe Road South,, Edinburgh, UK, EH4 2XU.
Cochrane Database Syst Rev. 2005 Jul 20(3):CD004742. doi: 10.1002/14651858.CD004742.pub2.
To date, standard recommendations for the management of stress urinary incontinence (SUI) would be either pelvic floor muscle training (PFMT) or surgery. A new form of drug treatment with a serotonin-noradrenaline reuptake inhibitor (SNRI), duloxetine, may now have a place in treatment of this condition.
To determine whether a SNRI is better than placebo (or no treatment, other pharmacological and non-pharmacological therapies, or surgery) in the treatment of women with SUI, or mixed urinary incontinence that includes stress incontinence (MUI), or both and which doses should be used.
We searched the Cochrane Incontinence Group specialised register (searched 1 December 2004), (CENTRAL) (Issue 2, 2004), MEDLINE (January 1966 to September 2004), PREMEDLINE (11 March 2004), Dissertation Abstracts and the reference lists of relevant articles.
All randomised or quasi-randomised controlled trials of treatment for SUI or MUI, in which at least one management arm involved a SNRI.
Two authors evaluated the trials for appropriateness for inclusion and methodological quality. Three authors performed the data extraction using predetermined criteria. Analyses were performed using the Cochrane Review Manager software, RevMan.
Nine randomised trials were included, involving 3327 adults with predominantly SUI, randomised to receive duloxetine or placebo. Both arms in individual trials were comparable for various baseline characteristics. Treatment duration was between three weeks and 12 weeks. Duloxetine was significantly better than placebo in terms of improving patients' quality of life (WMD 5.26, 95%CI 3.84 to 6.68. P< 0.00001) and perception of improvement. Individual studies demonstrated a significant reduction in the Incontinence Episode Frequency (IEF) by approximately 50% during treatment with duloxetine. With regard to objective cure, however, meta-analysis of stress pad test and 24 hour pad weight change failed to demonstrate a benefit for duloxetine over placebo though data were relatively few. Subjective cure favoured duloxetine, albeit with a small effect size (3%). One trial suggested that duloxetine was better than pelvic floor muscle training alone in reducing IEF (P < 0.05) based on median percentage decrease in IEF per week. Although significant side effects were commonly associated with duloxetine, they were reported as acceptable.
AUTHORS' CONCLUSIONS: The available evidence suggests that duloxetine treatment can significantly improve the quality of life of patients with stress urinary incontinence, but it is unclear whether or not benefits are sustainable. Adverse effects are common but not serious. About one in three participants allocated duloxetine reported adverse effects (most commonly nausea) related to treatment, and about one in eight allocated duloxetine stopped treatment as a consequence.
迄今为止,压力性尿失禁(SUI)的标准治疗方案是盆底肌训练(PFMT)或手术。一种新型药物治疗方法,即使用5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRI)度洛西汀,现在可能在这种疾病的治疗中占有一席之地。
确定SNRI在治疗SUI女性患者、包括压力性尿失禁的混合性尿失禁(MUI)患者或两者兼有的患者中是否优于安慰剂(或不治疗、其他药物和非药物治疗或手术),以及应使用何种剂量。
我们检索了Cochrane尿失禁专业注册库(2004年12月1日检索)、Cochrane系统评价数据库(2004年第2期)、医学期刊数据库(1966年1月至2004年9月)、预医学期刊数据库(2004年3月)、学位论文摘要以及相关文章的参考文献列表。
所有关于SUI或MUI治疗的随机或半随机对照试验,其中至少有一个治疗组涉及SNRI。
两位作者评估试验是否适合纳入以及方法学质量。三位作者使用预先确定的标准进行数据提取。使用Cochrane系统评价管理软件RevMan进行分析。
纳入了9项随机试验,涉及3327名主要为SUI的成年患者,随机接受度洛西汀或安慰剂治疗。各试验中两组的各种基线特征具有可比性。治疗持续时间为3周-12周。在改善患者生活质量方面,度洛西汀显著优于安慰剂(加权均数差5.26,95%可信区间3.84至6.68,P<0.00001)以及改善感知方面。个别研究表明,在度洛西汀治疗期间,尿失禁发作频率(IEF)显著降低约50%。然而,关于客观治愈,尽管数据相对较少,但压力垫试验和24小时尿垫重量变化的荟萃分析未能证明度洛西汀比安慰剂更具优势。主观治愈方面度洛西汀更具优势,尽管效应量较小(3%)。一项试验表明,基于每周IEF下降的中位数百分比,度洛西汀在降低IEF方面优于单独的盆底肌训练(P<0.05)。尽管度洛西汀通常伴有显著的副作用,但据报道这些副作用是可接受的。
现有证据表明,度洛西汀治疗可显著改善压力性尿失禁患者的生活质量,但尚不清楚益处是否可持续。不良反应常见但不严重。约三分之一分配到度洛西汀的参与者报告了与治疗相关的不良反应(最常见的是恶心),约八分之一分配到度洛西汀的参与者因此停止治疗。