Zúñiga Carlos, Piedimonte Fabian, Díaz Sergio, Micheli Federico
*Parkinson's Disease and Movement Disorders Program, Hospital de Clínicas José de San Martín, School of Medicine, University of Buenos Aires; †CENIT Foundation for Neuroscience Research and School of Medicine, University of Buenos Aires.
Clin Neuropharmacol. 2013 Sep-Oct;36(5):146-50. doi: 10.1097/WNF.0b013e31829cb60e.
A double-blind, randomized, placebo-controlled study of patients with essential trigeminal neuralgia and treatment with a single injection of onabotulinum toxin A (BTX) was carried out. The efficacy, safety, and tolerability of either 1 mL 0.9% saline plus 50 U of BTX or only 1 mL of 0.9% saline injected subcutaneously in the affected area were evaluated. Cases with involvement of the third branch of the trigeminal nerve also received intramuscularly either 10 U of BTX or matching placebo in the masseter muscle, ipsilateral to the pain location. Pain was assessed with the visual analog scale (VAS). Twenty subjects were administered BTX, and 16 subjects received placebo. Two months after the intervention, a trend to statistical significance was observed for the VAS mean values in subjects treated with BTX and those who received placebo (VAS 4.9 vs 6.63, t test, P = 0.07). Three months after the injection, significant differences were observed in the average VAS score for subjects treated with BTX and those treated with placebo (VAS 4.75 vs 6.94, respectively; t test, P = 0.01). Onabotulinum toxin A was well tolerated and seems to be a safe and useful therapy for patients with essential trigeminal neuralgia.
开展了一项针对原发性三叉神经痛患者的双盲、随机、安慰剂对照研究，采用单次注射A型肉毒毒素（BTX）进行治疗。评估了在患区皮下注射1 mL 0.9%生理盐水加50 U BTX或仅1 mL 0.9%生理盐水的疗效、安全性和耐受性。三叉神经第三支受累的病例还在咬肌（与疼痛部位同侧）肌肉内注射10 U BTX或匹配的安慰剂。采用视觉模拟量表（VAS）评估疼痛。20名受试者接受了BTX治疗，16名受试者接受了安慰剂治疗。干预两个月后，观察到接受BTX治疗的受试者与接受安慰剂治疗的受试者的VAS平均值有统计学意义的趋势（VAS分别为4.9和6.63，t检验，P = 0.07）。注射三个月后，观察到接受BTX治疗的受试者与接受安慰剂治疗的受试者的平均VAS评分有显著差异（分别为VAS 4.75和6.94；t检验，P = 0.01）。A型肉毒毒素耐受性良好，似乎是原发性三叉神经痛患者的一种安全有效的治疗方法。
