A型肉毒杆菌毒素治疗特发性逼尿肌过度活动症的疗效：一项单中心、随机、双盲、安慰剂对照试验的结果

Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial.

作者信息

Sahai Arun, Khan Mohammad Shamim, Dasgupta Prokar

机构信息

Department of Urology, Guy's, King's and St. Thomas's Hospitals, King's College London School of Medicine, London, United Kingdom.

出版信息

J Urol. 2007 Jun;177(6):2231-6. doi: 10.1016/j.juro.2007.01.130.

DOI:10.1016/j.juro.2007.01.130

PMID:17509328

Abstract

PURPOSE

We evaluated the use of botulinum toxin-A in treating patients with idiopathic detrusor overactivity refractory to anticholinergics.

MATERIALS AND METHODS

This double-blind, placebo controlled trial randomized participants to intradetrusor injections of 200 U botulinum toxin-A (16 patients) or placebo (18 patients). The primary outcome measure was change in maximum cystometric capacity. Secondary outcome measures included changes in overactive bladder symptoms, post-void residual, maximum detrusor pressure during filling cystometry and reflex detrusor volume. Quality of life was assessed using the Incontinence Impact Questionnaire short form 7 and Urogenital Distress Inventory short form 6. Followup occurred at 4 and 12 weeks after injection, at which point the study was unblinded. Further followup in the botulinum toxin-A group occurred at 24 weeks.

RESULTS

Significant increases in maximum cystometric capacity were observed at 4 weeks (difference 144.69 ml, 95% CI 100.95 to 215.75, p <0.0001) and 12 weeks (difference 95.71 ml, 95% CI 47.47 to 172.45, p = 0.001) in patients treated with botulinum toxin-A compared to placebo. Botulinum toxin-A reduced frequency (p <0.001, p = 0.003) and urgency urinary incontinence (p = 0.03, p = 0.008) episodes at 4 and 12 weeks, respectively. Urgency was reduced at 4 weeks (p = 0.005) in the botulinum toxin-A group. In patients receiving botulinum toxin-A, post-void residual increased at 4 weeks (p = 0.024) but became insignificant by 12 weeks (p = 0.406). Of these patients 6 required intermittent self-catheterization. Significant improvements in quality of life were observed following botulinum toxin-A. The extension study suggests that the beneficial effects of botulinum toxin-A are maintained for at least 24 weeks.

CONCLUSIONS

Botulinum toxin-A at 200 U is safe and effective for idiopathic detrusor overactivity and the beneficial effects persist for at least 24 weeks.

摘要

目的

我们评估了A型肉毒杆菌毒素用于治疗对抗胆碱能药物难治的特发性逼尿肌过度活动患者的效果。

材料与方法

这项双盲、安慰剂对照试验将参与者随机分为两组，分别接受200单位A型肉毒杆菌毒素膀胱内注射（16例患者）或安慰剂注射（18例患者）。主要观察指标是最大膀胱测压容量的变化。次要观察指标包括膀胱过度活动症状的变化、排尿后残余尿量、膀胱充盈测压期间的最大逼尿肌压力以及反射性逼尿肌容量。使用尿失禁影响问卷简表7和泌尿生殖系统困扰问卷简表6评估生活质量。在注射后4周和12周进行随访，此时研究揭盲。在24周时对A型肉毒杆菌毒素组进行进一步随访。

结果

与安慰剂组相比，接受A型肉毒杆菌毒素治疗的患者在4周时（差异为144.69毫升，95%可信区间为100.95至215.75，p<0.0001）和12周时（差异为95.71毫升，95%可信区间为47.47至172.45，p = 0.001）最大膀胱测压容量显著增加。A型肉毒杆菌毒素分别在4周和12周时减少了尿频发作次数（p<0.001，p = 0.003）和急迫性尿失禁发作次数（p = 0.03，p = 0.008）。在4周时，A型肉毒杆菌毒素组的尿急症状减轻（p = 0.005）。在接受A型肉毒杆菌毒素治疗的患者中，排尿后残余尿量在4周时增加（p = 0.024），但到12周时变得不显著（p = 0.406）。其中6例患者需要间歇性自我导尿。A型肉毒杆菌毒素治疗后生活质量有显著改善。延长研究表明，A型肉毒杆菌毒素的有益效果至少维持24周。