微小剂量A型肉毒毒素局部注射治疗复发性阿弗它溃疡的随机对照临床试验

SMALL DOSE BOTULINUM TOXIN A RELIEVES ORAL APHTHOUS ULCER PAIN—A RANDOMIZED,SINGLE-BLINDED CLINICAL TRIAL

目的:验证微小剂量A型肉毒毒素能减轻复发性阿弗它溃疡(RAU)疼痛的假设。方法:采用随机单盲对照临床试验,对80例未伴有系统性疾病的RAU病人进行单一剂量研究,分为两个组:A型肉毒毒素组,安慰剂对照组。治疗前与治疗后1至7天作视觉模拟评分法(VAS)疼痛评分。结果:治疗后2至6天区间A型肉毒毒素应用组能使原有疼痛减轻50%～82%,与治疗前比较,统计学差异显著(P<0.01);而同一时间安慰剂对照组VAS评分与治疗前相比无统计学差异。结论:小剂量A型肉毒毒素是有效减少复发性阿弗它溃疡疼痛的治疗方法。

Objective： To confirm the hypothesis that topically applied botulinum toxin type A can reduce aphthous ulcer pain. Methods： A randomized, single-blind, single dose study was performed in 80 aphthous ulcers patients without other symptom. These patients were divided into two groups：a botulinum toxin type A or placebo. The patients were asked to record the level of pain on the visual analogue scale for 7 days. They were also recorded any eventual side events or recurrence for 6 months. Results： Patients recovered more quickly following Botulinum toxin type A injection than those in placebo group; they would feel almost no pain after 3 days. Conclusions： The botulinum toxin type A is an effective and novel treatment for this common, painful disorder.