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。%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 tri-geminal neuralgia were randomized into three dose groups:BTX-A 25 U/mL(n=28), BTX-A 50 U/mL (n=31), BTX-A 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 re-duced 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 auto-matically 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 .
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