用3种剂量A型肉毒毒素治疗原发性三叉神经痛的疗效比较

Three doses of botulinum toxin type A for treatment of classic trigeminal neuralgia

目的:观察3种剂量A型肉毒毒素治疗三叉神经痛的疗效,焦虑、抑郁、睡眠变化及其不良反应。方法:选取原发性三叉神经痛患者87例,随机分为25 U/mL组(28例)、50 U/mL组(31例)和75 U/mL组(28例)3种剂量组,分别于疼痛部位多点皮内注射不同剂量的A型肉毒毒素,对每位患者治疗前及治疗后8周内每周进行视觉模拟(VAS)评分、焦虑评分、抑郁评分、睡眠干扰评分,并于第8周进行患者总体印象改变评分,观察疗效及其安全性。结果:3组治疗后疼痛治疗有效率差异无统计学意义(χ2=3.482,P=0.175)。治疗后3组焦虑、抑郁和睡眠评分均较各自治疗前显著降低,但3组有效率比较差异无统计学意义。治疗后3组患者总体印象改变改善率差异无统计学意义(χ2=1.345,P=0.510)。7例出现注射部位短暂性的肌肉松弛,2例出现注射部位肿胀,均自行消失,未进行处理,未见全身性不良反应。结论:不同剂量A型肉毒毒素治疗三叉神经痛均有效。

Aim： To observe the efficacy,anxiety,depression,sleep interference and adverse reaction of botulinum toxin type A（ BTX-A） with three doses for the treatment of trigeminal neuralgia. Methods： Eighty seven patients with trigeminal neuralgia were randomized into three dose groups： BTX-A 25 U /mL（ n = 28）,BTX-A 50 U /mL（ n = 31）,BTXA 75 U /mL（ n = 28） and local multi-point injection of different doses of BTX-A was administrated. Follow-up visits were conducted every week after the injection,and the overall duration of the study for each patient was 8 weeks to observe the visual analogue scale（ VAS）,anxiety,depression and sleep interference score and the patient global impression of change（ PGIC） scale at endpoint,assessing the efficacy and safety. Results： There was no significant difference in VAS efficacy among three groups（ χ2= 3. 482,P = 0. 175）. The scores of anxiety,depression and sleep interference of three groups reduced significantly compared to baseline screening period,but there were no significant differences among three groups.There were no significant differences in PGIC among three groups（ χ2= 1. 345,P = 0. 510）. Seven patients experienced transient muscle relaxation and two patients experienced edema in the injection area. All adverse reaction disappeared automatically without treatment,and there was no systemic adverse reaction. Conclusion： Three different doses of BTX-A for treatment of trigeminal neuralgia were all efficient,and there were no significant differences in multiple observation indexes among three groups.