Kuo Hann-Chorng, Jiang Yuan-Hong, Tsai Yao-Chou, Kuo Yuh-Chen
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University, Hualien, Taiwan.
School of Medicine, Tzu Chi University, Hualien, Taiwan.
Neurourol Urodyn. 2016 Jun;35(5):609-14. doi: 10.1002/nau.22760. Epub 2015 Apr 24.
Intravesical onabotulinumtoxinA (BoNT-A) injection is a beneficial treatment for interstitial cystitis/bladder pain syndrome (IC/BPS), yet its therapeutic efficacy remains to be validated. This study tests efficacy and safety of intravesical BoNT-A injections for treatment of IC/BPS.
A multicenter, randomized, double-blind, placebo-controlled trial in patients with IC/BPS refractory to conventional treatment. Patients were randomized in a 2:1 ratio to hydrodistention plus suburothelial injections of BoNT-A 100 U (Botox group) or the equivalent amount of normal saline (N/S group). The primary endpoint was a decrease in pain assessed using a visual analog scale (VAS) at week 8 after treatment. Secondary endpoints included voiding diary and urodynamic variables. The Wilcoxon sign rank and rank sum tests were used for statistical analyses.
A total of 60 patients (8 males, 52 females, age 50.8 ± 13.9 years) including 40 in the Botox and 20 in the N/S groups were enrolled. At week 8, a significantly greater reduction of pain was observed in the Botox group compared to the N/S group (-2.6 ± 2.8 vs. -0.9 ± 2.2, P = 0.021). The other variables did not differ significantly between groups except for cystometric bladder capacity, which was increased significantly in the Botox group. The overall success rates were 63% (26/40) in the Botox group and 15% (3/20) in the N/S group (P = 0.028). Adverse events did not differ between the groups.
Intravesical injections of 100 U of BoNT-A effectively reduced bladder pain symptoms in patients with IC/BPS. The adverse events were acceptable. Neurourol. Urodynam. 35:609-614, 2016. © 2015 Wiley Periodicals, Inc.
膀胱内注射A型肉毒杆菌毒素（BoNT-A）是间质性膀胱炎/膀胱疼痛综合征（IC/BPS）的一种有效治疗方法，但其治疗效果仍有待验证。本研究旨在测试膀胱内注射BoNT-A治疗IC/BPS的疗效和安全性。
一项针对常规治疗无效的IC/BPS患者的多中心、随机、双盲、安慰剂对照试验。患者按2:1的比例随机分为两组，分别接受膀胱水扩张联合膀胱黏膜下注射100 U BoNT-A（肉毒杆菌毒素组）或等量生理盐水（生理盐水组）。主要终点是治疗后第8周使用视觉模拟量表（VAS）评估的疼痛减轻情况。次要终点包括排尿日记和尿动力学变量。采用Wilcoxon符号秩和检验和秩和检验进行统计分析。
共纳入60例患者（男性8例，女性52例，年龄50.8±13.9岁），其中肉毒杆菌毒素组40例，生理盐水组20例。在第8周时，与生理盐水组相比，肉毒杆菌毒素组的疼痛减轻更为显著（-2.6±2.8 vs. -0.9±2.2，P = 0.021）。除膀胱测压容量外，其他变量在两组之间无显著差异，肉毒杆菌毒素组的膀胱测压容量显著增加。肉毒杆菌毒素组的总体成功率为63%（26/40），生理盐水组为15%（3/20）（P = 0.028）。两组的不良事件无差异。
膀胱内注射100 U BoNT-A可有效减轻IC/BPS患者的膀胱疼痛症状。不良事件可接受。《神经泌尿学与尿动力学》35:609-614，2016年。©2015威利期刊公司。
