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肉毒杆菌毒素与安慰剂:预防性治疗偏头痛的荟萃分析

Botulinum Toxin versus Placebo

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【 文献重点摘要 】
 

Background: The purpose of this study was to assess the efficacy of botulinum toxin in reducing the frequency of migraine headaches.

 

Methods: The MEDLINE, Embase, and Cochrane Library databases were searched to identify randomized, double-blind, placebo-controlled trials that compared patients receiving botulinum toxin versus placebo injections in the head and neck muscles, for the preventive treatment of migraine. The primary outcome was change in the number of headache episodes per month from baseline to 3 months.

 

Results: There were 17 studies including a total of 3646 patients. Overall analysis reported a tendency in favor of botulinum toxin over placebo at 3 months, with a mean difference in the change of migraine frequency of −0.23 (95 percent CI, −0.47 to 0.02; p = 0.08). The reduction in frequency of chronic migraines was significant, with a mean differential change of −1.56 (95 percent CI, −3.05 to −0.07; p = 0.04). Analysis of chronic migraine frequency was also significant after 2 months. The findings also highlighted an improvement of the patient’s quality of life at 3 months in the botulinum toxin group (p < 0.00001). Further adverse events were traced in the botulinum toxin type A group with a statistically significant risk ratio of 1.32 (p = 0.002).

 

Conclusions: This meta-analysis reveals that botulinum toxin type A injections are superior to placebo for chronic migraines after 3 months of therapy. For the first time, a real benefit in patient quality of life is demonstrated with only few and mild adverse events.

 

背景:本研究的目的是评估肉毒杆菌毒素在减少偏头痛频率方面的效果。

 

方法:搜索MEDLINE、EMBASE和Cochrane图书馆数据库,确定随机、双盲、安慰剂对照试验,比较接受肉毒杆菌毒素的患者和头颈部肌肉注射安慰剂的患者预防偏头痛的效果。主要结果是每月头痛发作次数从基线到3个月的变化。

 

结果:共有17项研究,共3646例患者。总体分析显示在3个月时肉毒杆菌毒素比安慰剂更倾向于使用肉毒杆菌毒素,−的偏头痛频率变化的平均差异为0.23(95%CI,−为0.47to0.02;p=0.08)。慢性偏头痛的频率显著减少,平均差值变化为−1.5 6(95%CI,−3.0 5至−0.0 7;p=0.0 4)。慢性偏头痛频率的分析在2个月后也有显著意义。研究结果还强调了肉毒杆菌毒素组患者3个月后生活质量的改善(p<0.00001)。在A型肉毒毒素组中还追踪到了进一步的不良事件,有统计学意义的风险比为1.32%(p=0.002)。

 

结论:这项荟萃分析显示,治疗3个月后,A型肉毒毒素注射治疗慢性偏头痛优于安慰剂。这是第一次,仅有很少和轻微的不良事件被证明对患者的生活质量有真正的好处。

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