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一项关于抗毒蕈碱药物治疗膀胱过度活动症的随机对照试验的系统评价和荟萃分析。

A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder.

作者信息

Novara Giacomo, Galfano Antonio, Secco Silvia, D'Elia Carolina, Cavalleri Stefano, Ficarra Vincenzo, Artibani Walter

机构信息

I.R.C.C.S. Istituto Oncologico Veneto, Padua, Italy.

出版信息

Eur Urol. 2008 Oct;54(4):740-63. doi: 10.1016/j.eururo.2008.06.080. Epub 2008 Jul 9.

Abstract

CONTEXT

Anticholinergic drugs are commonly used in patients with overactive bladder (OAB) who do not achieve symptom relief and quality of life improvement with conservative management. Several drugs, with different doses, formulations, and routes of administration are currently available, making the choice quite difficult.

OBJECTIVE

To evaluate efficacy and safety of different doses, formulations, and route of administration of the available anticholinergic drugs.

EVIDENCE ACQUISITION

A systematic review of the literature was performed in August 2007 using Medline, Embase, and Web of Science. Efficacy (micturitions per 24h, volume voided per micturition, urgency urinary incontinence episodes per 24h, incontinence episodes per 24h) and safety (mainly, adverse events and withdrawal rates) end points were evaluated in the randomized control trials (RCTs) assessing the role of anticholinergic drugs in non-neurogenic OAB. Meta-analysis of RCTs was conducted using the Review Manager software 4.2 (Cochrane Collaboration).

EVIDENCE SYNTHESIS

Our systematic search identified 50 RCTs and three pooled analyses. Tolterodine immediate release (IR) had a more favorable profile of adverse events than oxybutynin IR. Regarding different dosages of IR formulations, dose escalation might yield some limited improvements in the efficacy but at the cost of significant increase in the rate of adverse events. In the comparisons between IR and extended-release (ER) formulations, the latter showed some advantages, both in terms of efficacy and safety. With regard to the route of administration, use if a transdermal route of administration does not provide significant advantage over an oral one.

CONCLUSION

Many of the available RCTs have good methodological quality. ER formulations should be preferred to the IR ones. With regard to IR formulations, dose escalation might yield some improvements in the efficacy with significant increase in the AE. More clinical studies are needed to indicate which of the drugs should be used as first-, second-, or third-line treatment.

摘要

背景

对于膀胱过度活动症(OAB)患者,若采用保守治疗无法缓解症状及改善生活质量,抗胆碱能药物通常会被使用。目前有几种不同剂量、剂型及给药途径的药物可供选择,这使得选择变得相当困难。

目的

评估现有抗胆碱能药物不同剂量、剂型及给药途径的疗效和安全性。

证据获取

2007年8月利用Medline、Embase和科学网对文献进行了系统综述。在评估抗胆碱能药物在非神经源性OAB中作用的随机对照试验(RCT)中,对疗效(每24小时排尿次数、每次排尿尿量、每24小时急迫性尿失禁发作次数、每24小时失禁发作次数)和安全性(主要为不良事件和撤药率)终点进行了评估。使用Review Manager软件4.2(Cochrane协作网)对RCT进行荟萃分析。

证据综合

我们的系统检索确定了50项RCT和三项汇总分析。速释托特罗定的不良事件情况比速释奥昔布宁更有利。关于速释制剂的不同剂量,剂量增加可能会在疗效上产生一些有限的改善,但代价是不良事件发生率显著增加。在速释制剂与缓释制剂的比较中,后者在疗效和安全性方面均显示出一些优势。关于给药途径,经皮给药途径相对于口服给药途径并无显著优势。

结论

许多现有RCT具有良好的方法学质量。应优先选择缓释制剂而非速释制剂。对于速释制剂,剂量增加可能会在疗效上有所改善,但不良事件会显著增加。需要更多的临床研究来指明哪些药物应作为一线、二线或三线治疗药物。

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