A型肉毒毒素预防性治疗偏头痛有效性及安全性的随机对照试验的meta分析

目的评价A型肉毒毒素预防性治疗偏头痛的有效性和安全性。方法计算机检索PubMed、Embase、Cochrane Library、SinoMed (CBM)、中国知网、万方等数据库中相关随机对照试验(RCT),采用Review manager 5. 3软件对数据进行meta分析。结果共纳入12项RCT,纳入4131例患者。meta分析结果显示,与安慰剂组比较,A型肉毒毒素组在平均每月偏头痛发作频率减少方面无明显差异(MD=-0. 1,95%CI:0. 41-0. 21,P=0. 53)。按偏头痛类型进行亚组分析后结果显示,A型肉毒毒素组在亚组慢性偏头痛组平均每月偏头痛发作频率减少方面优于安慰剂组(MD=-0. 43,95%CI:-0. 70～-0. 17,P=0. 001);而在亚组发作性偏头痛组,A型肉毒毒素组和安慰剂组在每月平均偏头痛发作频率减少方面无明显差异(MD=0. 08,95%CI:-0. 16～0. 33; P=0. 51)。与安慰剂组相比,A型肉毒毒素组平均每月偏头痛天数减少、平均每月急性头痛用药日数减少、生活质量量表评分改善情况等方面均优于安慰剂组(P 0. 05);总不良事件发生率均高于安慰剂组(OR=1. 38,95%CI:1. 20～1. 58; P 0. 00 001),但无严重不良反应发生。结论 A型肉毒毒素能有效地减少慢性偏头痛每月偏头痛发作频率、偏头痛天数和急性头痛用药的时间及改善生活质量,但对发作性偏头痛效果不明显,不良反应可耐受。

Efficacy and safety of botulinum toxin A inprophylactic treatment of migraine: A meta-analysis of randomized controlled trials

Objective To evaluate the efficacy and safety of botulinum toxin A in the prophylactic treatment of migraine.Methods PubMed, Embase, Cochrane Library, SinoMed (CMB), CNKI, and Wanfang Data were searched for relevant randomized controlled trials(RCTs),and Review Manager 5.3 software was used to perform a meta-analysis.Results A total of 12 RCTs were included, with 4131 patients in total. The meta-analysis showed that there was no significant difference in the reduction in monthly average frequency of migraine attacks between the experimental group and the placebo group (mean difference[MD]=-0.1, 95% confidence interval[CI]:-0.41 to 0.21, P=0.53). The subgroup analysis based on the type of migraine showed that for patients in the chronic migraine subgroup, the botulinum toxin A group had a significantly greater reduction in monthly average frequency of migraine attacks compared with the placebo group (MD=-0.43, 95%CI:-0.70 to -0.17, P=0.001), while for patients in the episodic migraine subgroup, there was no significant difference in the reduction in monthly average frequency of migraine attacks between the botulinum toxin A group and the placebo group (MD=0.08, 95%CI:-0.16 to 0.33, P=0.51). Compared with the placebo group, the botulinum toxin A group had significantly greater improvements in monthly average number of days with migraine attacks, monthly average number of days of medication for acute headache, and quality-of-life score (P<0.05). The botulinum toxin A group had a significantly higher overall incidence rate of adverse events than the placebo group (odds ratio[OR]=1.38, 95%CI:1.20 to 1.58, P<0.00 001), but no serious adverse events were observed.Conclusions Botulinum toxin A can effectively reduce monthly frequency of migraine attacks, number of days with migraine, and number of days of medication for acute headache and improve quality of life in patients with chronic migraine, with a lack of marked effect on episodic migraine, and the adverse eventsare tolerable.