Division of Neurology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Headache. 2011 Jan;51(1):52-63. doi: 10.1111/j.1526-4610.2010.01807.x. Epub 2010 Nov 16.
To evaluate the efficacy, safety, and optimum dose of a highly purified Clostridium botulinum type A toxin-hemagglutinin complex (Dysport) for migraine prophylaxis.
Botulinum toxin type-A has demonstrated good efficacy in several open-label studies of patients with migraine, involving either individualized or standardized protocols, although data from placebo-controlled trials have been conflicting.
A 12-week, double-blind, randomized trial of Dysport (120 or 240 units) vs placebo was conducted in 6 centers in Thailand to evaluate the efficacy, safety, and optimum dose of botulinum toxin type-A (Dysport) for migraine prophylaxis. A total of 128 patients with migraine without aura were enrolled. The primary end point was the change in the mean number of migraine attacks per 4-week period from the pre-treatment period to 8-12 weeks post injection. Secondary efficacy measures included the change in the mean total intensity score from the pre-treatment period to 8-12 weeks, the investigator and patient global assessments of change at each visit compared with pre-treatment, and Migraine Disability Assessment and Short Form-36 scores.
Change in number of migraine attacks from pre-treatment to weeks 8-12 was not significantly different. There was a greater improvement in total intensity score at weeks 8-12 with Dysport-240 (not significant), and interim visit data showed that this was significant at weeks 0-4 (P = .03 Dysport-240 vs placebo). The mean duration of headache during weeks 0-4 was lower with Dysport-240 (P = .04 vs placebo). Improvements in patient and investigator global assessments of change between weeks 0-4 and 8-12 were significant for the Dysport-240 group (both P < .05 vs placebo).
Limitations in study design and assessment tools employed may have contributed to the inconclusive nature of the primary end point data. Dysport-240 showed significant benefit over placebo at some end points and further trials with more appropriate outcome measures are required to evaluate effectively this treatment.
评估高度纯化的 A 型肉毒梭菌毒素-血凝素复合物（Dysport）治疗偏头痛预防的疗效、安全性和最佳剂量。
肉毒毒素 A 在几项涉及个体化或标准化方案的偏头痛开放性研究中显示出良好的疗效，尽管安慰剂对照试验的数据存在矛盾。
在泰国的 6 个中心进行了一项为期 12 周、双盲、随机的 Dysport（120 或 240 单位）与安慰剂对照试验，以评估肉毒毒素 A（Dysport）治疗偏头痛预防的疗效、安全性和最佳剂量。共纳入 128 例无先兆偏头痛患者。主要终点是从治疗前到注射后 8-12 周每 4 周偏头痛发作次数的平均变化。次要疗效指标包括从治疗前到 8-12 周总强度评分的变化、每次就诊时研究者和患者对变化的全球评估与治疗前相比，以及偏头痛残疾评估和简短形式 36 评分的变化。
从治疗前到 8-12 周偏头痛发作次数的变化无显著差异。Dysport-240 组在 8-12 周时总强度评分的改善更大（无显著性），中期访视数据显示，0-4 周时这一改善具有显著性（P=Dysport-240 与安慰剂相比，差异有统计学意义）。0-4 周时 Dysport-240 组头痛持续时间较低（P=0.04 与安慰剂相比）。0-4 周和 8-12 周时，Dysport-240 组患者和研究者对变化的全球评估的改善均有显著意义（两组均 P<0.05 与安慰剂相比）。
研究设计和评估工具的局限性可能导致主要终点数据的不确定性质。Dysport-240 在某些终点上显示出明显优于安慰剂的疗效，需要进一步的临床试验，采用更合适的疗效指标，以有效地评估这种治疗方法。
