Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University, Hualien, Taiwan.
Int J Clin Pract. 2013 May;67(5):427-34. doi: 10.1111/ijcp.12113.
To evaluate the efficacy and safety of repeated intravesical onabotulinumtoxinA (BoNT-A) injections for treatment of interstitial cystitis/bladder pain syndrome (IC/BPS).
Patients confirmed to have IC/BPS and refractory to conventional treatments were treated with intravesical injections of 100 U of BoNT-A plus hydrodistention every 6 months for up to four times. Primary end-point was 6 months after the fourth BoNT-A injection. Measured parameters included O'Leary-Sant symptom score (OSS) including symptom and problem indexes (ICSI/ICPI), visual analogue score (VAS) for pain, voiding diary variables, urodynamic parameters, maximal bladder capacity (MBC), glomerulation grade, and global response assessment (GRA). Multiple measurements and Wilcoxon rank-sum test were used for comparison between groups.
In overall patients, GRA, OSS, ICSI and ICPI scores, VAS, functional bladder capacity (FBC) and cystometric bladder capacity (CBC) all showed significant improvement. The glomerulation grade decreased (1.77 ± 1.06 vs. 1.19 ± 1.05, p = 0.026), but MBC remained unchanged. Among 31 patients, 19 (61%) had a GRA ≥ 2 and 12 (39%) had a GRA < 2 at end-point. Patients with a GRA ≥ 2 had significantly greater changes in OSS, ICPI, VAS, FBC and CBC than patients with a GRA < 2. Extended study revealed that persistent symptomatic improvement lasted 6-12 months in seven, 13-22 months in six and 23-51 months in six after the fourth BoNT-A injection. Five women who had GRA < 2 were found to have Hunner's ulcer. Lack of control is the main limitation.
Four repeated intravesical BoNT-A injections were safe and effective for symptom and pain relief and increased bladder capacity for treatment of IC/BPS.
评估重复膀胱内注射肉毒毒素 A（BoNT-A）治疗间质性膀胱炎/膀胱疼痛综合征（IC/BPS）的疗效和安全性。
对经常规治疗无效的 IC/BPS 患者，行膀胱内注射 100U BoNT-A 联合水扩张治疗，每 6 个月 1 次，最多 4 次。主要终点为第 4 次 BoNT-A 注射后 6 个月。测量参数包括 O'Leary-Sant 症状评分（OSS），包括症状和问题指数（ICSI/ICPI）、疼痛视觉模拟评分（VAS）、排尿日记变量、尿动力学参数、最大膀胱容量（MBC）、肾小球分级和总体反应评估（GRA）。采用多个测量值和 Wilcoxon 秩和检验比较组间差异。
总体患者的 GRA、OSS、ICSI 和 ICPI 评分、VAS、功能性膀胱容量（FBC）和膀胱测压容量（CBC）均显著改善。肾小球分级下降（1.77±1.06 比 1.19±1.05，p=0.026），但 MBC 无变化。31 例患者中，19 例（61%）GRA≥2，12 例（39%）GRA<2。GRA≥2 的患者 OSS、ICPI、VAS、FBC 和 CBC 的变化明显大于 GRA<2 的患者。扩展研究显示，7 例患者在第 4 次 BoNT-A 注射后 6-12 个月、6 例患者在 13-22 个月、6 例患者在 23-51 个月持续症状改善，5 例 GRA<2 的女性患者出现 Hunner 溃疡。主要限制因素是缺乏控制。
重复膀胱内注射 BoNT-A 4 次治疗 IC/BPS 安全有效，可缓解症状和疼痛，增加膀胱容量。
