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肉毒杆菌毒素注射用于治疗成人膀胱过度活动症。

Botulinum toxin injections for adults with overactive bladder syndrome.

作者信息

Duthie J, Wilson D I, Herbison G P, Wilson D

出版信息

Cochrane Database Syst Rev. 2007 Jul 18(3):CD005493. doi: 10.1002/14651858.CD005493.pub2.

Abstract

BACKGROUND

Overactive bladder syndrome is a common condition with a significant negative impact on quality of life. Intravesical injection of botulinum toxin is increasingly used as an intervention for refractory overactive bladder, with a considerable body of case reports and series in the literature suggesting beneficial effects.

OBJECTIVES

The objective was to compare intravesical botulinum toxin injection with other treatments for neurogenic and idiopathic overactive bladder in adults. The hypotheses addressed were whether intravesical injection of botulinum toxin was better: than placebo or no treatment, pharmacological and other non-pharmacological interventions, whether higher doses of botulinum toxin were better than lower doses, whether botulinum toxin in combination with other treatments was better than other treatments alone, whether one formulation of botulinum toxin is better than another, and whether one injection technique was better than another.

SEARCH STRATEGY

We searched the Cochrane Incontinence Group Specialised Trials Register (searched 22 November 2005). The register contains trials identified from MEDLINE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), and handsearching of journals and conference proceedings. Additionally, all reference lists of selected trials were searched. No limitations were placed on the searches.

SELECTION CRITERIA

All randomised or quasi-randomised controlled trials of treatment for overactive bladder syndrome in adults in which at least one management arm involved intravesical injection of botulinum toxin were included. Participants had either neurogenic or idiopathic overactive bladder with or without stress incontinence. Comparison interventions could include no intervention; placebo; lifestyle modification; bladder retraining; pharmacological treatments; surgery; bladder instillation techniques; neuromodulation; and different types, doses, and injection techniques of botulinum toxin.

DATA COLLECTION AND ANALYSIS

Binary outcomes were presented as relative risk and continuous outcomes by mean differences. No data could be synthesised across studies due to differing designs and outcome measures. Data were tabulated where possible with results taken from trial reports where this was not possible. Where multiple publications were found, the reports were treated as a single source of data.

MAIN RESULTS

Eight studies met the inclusion criteria. Results varied between studies. For the most part, studies reported superiority of botulinum toxin A to placebo in such outcomes as incontinence episodes, bladder capacity, maximum detrusor pressure, and quality of life. Low doses of botulinum toxin (100U to150U) appeared to have beneficial effects, but higher doses (300U) may have been more effective. Botulinum toxin appeared to have beneficial effects in overactive bladder that quantitatively exceeded the effects of intravesical resiniferatoxin.

AUTHORS' CONCLUSIONS: Intravesical botulinum toxin shows promise as a therapy for overactive bladder symptoms, but as yet too little controlled trial data exist on benefits and safety compared with other interventions, or with placebo. Practitioners should be aware that at present there is little more than anecdotal evidence, in the form of case reports to support the efficacy of intravesical botulinum toxin; there is not much in the way of substantial, robust safety data. Furthermore, the optimal dose of botulinum toxin for efficacy and safety has not yet been demonstrated.

摘要

背景

膀胱过度活动症是一种常见病症,对生活质量有显著负面影响。膀胱内注射肉毒杆菌毒素越来越多地被用作难治性膀胱过度活动症的一种干预措施,文献中有大量病例报告和系列研究表明其具有有益效果。

目的

比较膀胱内注射肉毒杆菌毒素与其他治疗方法对成人神经源性和特发性膀胱过度活动症的疗效。探讨的假设包括:膀胱内注射肉毒杆菌毒素是否优于安慰剂或不治疗、药物及其他非药物干预措施;高剂量肉毒杆菌毒素是否优于低剂量;肉毒杆菌毒素联合其他治疗是否优于单独使用其他治疗;一种肉毒杆菌毒素制剂是否优于另一种;以及一种注射技术是否优于另一种。

检索策略

我们检索了Cochrane尿失禁组专业试验注册库(检索时间为2005年11月22日)。该注册库包含从MEDLINE、CINAHL、Cochrane对照试验中央注册库(CENTRAL)中识别出的试验,以及对期刊和会议论文集的手工检索。此外,还检索了所选试验的所有参考文献列表。检索无任何限制。

入选标准

纳入所有针对成人膀胱过度活动症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膀胱内注射肉毒杆菌毒素。参与者患有神经源性或特发性膀胱过度活动症,伴有或不伴有压力性尿失禁。比较干预措施可包括不干预、安慰剂、生活方式改变、膀胱再训练、药物治疗、手术、膀胱灌注技术、神经调节,以及不同类型、剂量和注射技术的肉毒杆菌毒素。

数据收集与分析

二分类结局以相对危险度表示,连续性结局以平均差值表示。由于设计和结局测量方法不同,无法对各研究的数据进行综合分析。数据尽可能制成表格,若无法从试验报告中获取结果,则采用其他方式。若发现多篇相关出版物,则将这些报告视为单一数据源。

主要结果

八项研究符合纳入标准。各研究结果存在差异。在很大程度上,研究报告称A型肉毒杆菌毒素在尿失禁发作次数、膀胱容量、最大逼尿肌压力和生活质量等结局方面优于安慰剂。低剂量肉毒杆菌毒素(100U至150U)似乎具有有益效果,但高剂量(300U)可能更有效。肉毒杆菌毒素在膀胱过度活动症中似乎具有有益效果,其效果在数量上超过膀胱内注射树脂毒素。

作者结论

膀胱内注射肉毒杆菌毒素有望成为治疗膀胱过度活动症症状的一种疗法,但与其他干预措施或安慰剂相比,目前关于其益处和安全性的对照试验数据仍太少。从业者应意识到,目前仅有病例报告形式的轶事证据支持膀胱内注射肉毒杆菌毒素的疗效;缺乏大量有力的安全性数据。此外,尚未证明肉毒杆菌毒素在疗效和安全性方面的最佳剂量。

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