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[目的]观察托吡酯预防月经性偏头痛发作的临床疗效和安全性。[方法]112例月经性偏头痛患者随机分为A组22例、B组26例、C组24例、D组19例和E组21例,A、B、C、D组均口服托吡酯,初始量50mg/d,每周增加25mg,4组维持量分别为75、100、150和200mg/d,均连续用药3个月;E组口服安慰剂。观察发作频率、每次发作持续时间、疼痛程度变化及不良反应。[结果]A组有效率18/22,B组有效率22/26,C组有效率20/24,D组有效率16/19,E组有效率4/21,A、B、C、D组疗效均优于E组(P﹤0.01)且4组之间疗效无明显差异(P﹥0.05)。A、B、C组分别出现3例、5例和6例轻度不良反应;D组出现8例不良反应,且明显重于A、B、C组。[结论]托吡酯(75～150)mg/d预防月经性偏头痛疗效显著、安全性高。
[Objective] To observe the clinical efficacy and safety of topiramate in preventing the onset of menstrual migraine. [Methods] A total of 112 patients with menstrual migraine were randomly divided into group A (n = 22), group B (n = 26), group C (n = 24), group D (n = 19) and group E The initial dose of 50mg / d, weekly increase of 25mg, 4 groups were maintained at 75,100,150 and 200mg / d, were continuous medication for 3 months; E placebo oral placebo. Frequency of seizures, duration of each episode, changes in pain levels and adverse reactions were observed. [Result] The effective rate of group A was 18/22, that of group B was 22/26, that of group C was 20/24, that of group D was 16/19, that of group E was 4/21, and that of group A, B, C, D The curative effect of group A was superior to that of group E (P <0.01). There was no significant difference between the four groups (P> 0.05). There were 3 cases, 5 cases and 6 mild adverse reactions in group A, B and C, respectively. There were 8 adverse reactions in group D, which were significantly higher than those in groups A, B and C. [Conclusion] Topiramate (75 ~ 150) mg / d is effective in preventing menstrual migraine with high safety.