The First Affiliated Hospital of Zhengzhou University, China.
Cephalalgia. 2012 Apr;32(6):443-50. doi: 10.1177/0333102412441721. Epub 2012 Apr 5.
To investigate the efficacy, safety and tolerability of intradermal and/or submucosal administration of botulinum toxin type A (BTX-A) for patients with trigeminal neuralgia (TN).
In this randomized, double-blind, placebo-controlled study, 42 TN patients were randomly allocated into two groups, namely, intradermal and/or submucosal injection of BTX-A (75 U/1.5 mL; n = 22) or saline (1.5 mL; n = 20) in the skin and/or mucosa where pain was experienced. The primary endpoints were pain severity (assessed by the visual analogue scale) and pain attack frequency per day. The secondary endpoint was the patient's overall response to treatment, assessed using the Patient Global Impression of Change scale. Patients with ≥ 50% reduction in mean pain score at week 12 were defined as responders.
A total of 40 patients completed the study. BTX-A significantly reduced pain intensity at week 2 and pain attack frequency at week 1. The efficacy was maintained throughout the course of the study. More BTX-A treated patients reported that pain had improved by the end of the study. Significantly more responders were present in the BTX-A group (68.18%) than in the placebo group (15.00%). BTX-A was well tolerated, with few treatment-related adverse events.
BTX-A may be an efficient, safe and novel strategy for TN treatment.
研究皮内和/或黏膜下注射肉毒毒素 A（BTX-A）治疗三叉神经痛（TN）患者的疗效、安全性和耐受性。
这是一项随机、双盲、安慰剂对照研究，42 例 TN 患者随机分为两组，即皮内和/或黏膜下注射 BTX-A（75 U/1.5 mL；n=22）或生理盐水（1.5 mL；n=20）于疼痛部位的皮肤和/或黏膜。主要终点是疼痛严重程度（视觉模拟评分）和每天疼痛发作频率。次要终点是患者整体治疗反应，采用患者变化总体印象量表进行评估。第 12 周时平均疼痛评分降低≥50%的患者定义为应答者。
共有 40 例患者完成了研究。BTX-A 可显著降低第 2 周的疼痛强度和第 1 周的疼痛发作频率。疗效在整个研究过程中得以维持。研究结束时，更多接受 BTX-A 治疗的患者报告疼痛有所改善。BTX-A 组的应答者（68.18%）明显多于安慰剂组（15.00%）。BTX-A 耐受性良好，治疗相关不良事件较少。
BTX-A 可能是治疗 TN 的一种有效、安全且新颖的策略。
