【 文献重点摘要 】
 

Objectives: Cumulative evidence support a beneficial effect of botulinum toxin A (BTX-A) in postherpetic neuralgia (PHN). We aimed to assess efficacy, safety, and tolerability of BTX-A in the management of PHN, performing a randomized, double-blind, single-dose, placebo-controlled trial.

Methods: Thirty adults with PHN were randomized either to BTXA or placebo. Severity of pain was evaluated by patients using a visual analogue scale (VAS) and quality of sleep was assessed using a 5-item questionnaire. Primary outcome was reduction in VAS score, with a greater than 50% reduction being considered clinically significant. Secondary outcomes were reduction in sleep score and maintenance of VAS score after treatment, with over 50% maintenance considered clinically meaningful.

Results: Thirteen patients from the experimental arm achieved an at least 50% reduction in VAS score, compared with none of the placebo patients (NNT = 1.2, 95% CI, 2-1; ARR = 0.87, 95% CI, 055-096; P< 0.001). BTX-A patients showed significant reduction in VAS pain scores between baseline and week 2, which persisted for a median period of 16 weeks. BTX-A patients showed significant reduction in sleep scores between baseline and week 2, which remained unchanged until 16th week (P< 0.001). Treatment was well tolerated.

Discussion: Data confirm that BTX-A is effective and well tolerated in the treatment of PHN.

Keywords: botulinum toxin, herpes zoster, neuropathic pain, postherpetic neuralgia, randomized clinical trial

目的：累积证据支持A型肉毒毒素(BTX-A)治疗带状疱疹后遗神经痛(PHN)的有益效果。我们进行了一项随机、双盲、单剂量、安慰剂对照试验，旨在评估BTX-A治疗PHN的有效性、安全性和耐受性。

方法：30例成人PHN患者被随机分为BTXA组和安慰剂组。疼痛严重程度由患者使用视觉模拟评分(VAS)评估，睡眠质量由5个项目的问卷评估。主要结果是VAS评分降低，超过50%的降低被认为具有临床意义。次要结果是治疗后睡眠评分降低和VAS评分维持，超过50%的维持被认为具有临床意义。

结果：试验组中有13例患者的视觉模拟评分至少降低了50%，而安慰剂组则没有。(NNT=1.2，95%CI，2-1；ARR=0.87，95%CI，0.55-0 96；P<0.001)。BTX-A患者在基线和第2周期间VAS疼痛评分显著降低，中位数持续时间为16周。BTX-A患者的睡眠评分在基线和第2周之间显著降低，直到第16周保持不变(P<0.001)。治疗耐受性良好。

讨论：数据证实BTX-A治疗PHN有效且耐受性良好。

关键词：肉毒毒素，带状疱疹，神经病理性疼痛，带状疱疹后神经痛，随机临床试验