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肉毒杆菌毒素治疗逼尿肌过度活动所致尿失禁:有效性和不良反应的系统评价

Botulinum toxin for treatment of urinary incontinence due to detrusor overactivity: a systematic review of effectiveness and adverse effects.

作者信息

MacDonald R, Fink H A, Huckabay C, Monga M, Wilt T J

机构信息

Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research and the Cochrane Review Group in Prostate Diseases and Urologic Cancers (111-0), Veterans Affairs Medical Center, 1 Veterans Drive, Minneapolis, MN 55417, USA.

出版信息

Spinal Cord. 2007 Aug;45(8):535-41. doi: 10.1038/sj.sc.3102070. Epub 2007 Apr 24.

DOI:10.1038/sj.sc.3102070
PMID:17453012
Abstract

STUDY DESIGN

Systematic review.

OBJECTIVE

To evaluate effectiveness and adverse effects of botulinum toxin (BTX) for treatment of urinary incontinence (UI) due to detrusor overactivity (DO).

METHODS

Randomized controlled trials published in English before November 2006 were included if they enrolled subjects with UI caused by DO and reported incontinence outcomes.

RESULTS

Three trials totaling 104 subjects with DO refractory to antimuscarinic treatment were included. Two BTX-A trials enrolled primarily patients with NDO secondary to spinal cord injury (SCI) (93%). BTX-A decreased daily UI episodes compared to placebo but the reductions were only significantly different at a few of the time intervals during 24 weeks of follow-up. BTX-A was superior in reducing daily UI episodes in SCI subjects compared to intravesical resiniferatoxin at 12 and 18 months after injections. A small crossover study found BTX-B significantly more effective than placebo in reducing weekly UI episodes in subjects with predominately idiopathic DO. Adverse events (AEs) in BTX-A-treated subjects included urinary tract infection, pain at the injection site, hematuria and autonomic dysreflexia. Four subjects treated with BTX-B reported autonomic AEs.

CONCLUSIONS

BTX may improve UI for subjects with refractory DO. The preferred dose and type of BTX is not known. Long-term efficacy and safety remain unclear and require conduct of larger RCT using standardized and validated clinical outcomes measures.

摘要

研究设计

系统评价。

目的

评估肉毒杆菌毒素(BTX)治疗逼尿肌过度活动(DO)所致尿失禁(UI)的有效性和不良反应。

方法

纳入2006年11月前发表的英文随机对照试验,这些试验纳入了因DO导致UI的受试者并报告了尿失禁结果。

结果

纳入三项试验,共104例对抗毒蕈碱治疗无效的DO患者。两项BTX-A试验主要纳入继发于脊髓损伤(SCI)的神经源性DO患者(93%)。与安慰剂相比,BTX-A减少了每日UI发作次数,但在24周随访期间,仅在少数时间间隔内减少有显著差异。与膀胱内注射树脂毒素相比,注射后12个月和18个月时,BTX-A在减少SCI患者每日UI发作次数方面更具优势。一项小型交叉研究发现,BTX-B在减少以特发性DO为主的受试者每周UI发作次数方面明显比安慰剂更有效。接受BTX-A治疗的受试者的不良事件(AE)包括尿路感染、注射部位疼痛、血尿和自主神经反射异常。四名接受BTX-B治疗的受试者报告了自主神经AE。

结论

BTX可能改善难治性DO患者的UI。BTX的最佳剂量和类型尚不清楚。长期疗效和安全性仍不明确,需要采用标准化和经过验证的临床结局指标进行更大规模的随机对照试验。

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