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目的评价国产盐酸洛美利嗪治疗偏头痛的疗效及安全性。方法采取随机、双盲、安慰剂对照进行观察,将入选的53例患者随机分为盐酸洛美利嗪治疗组(27例,口服盐酸洛美利嗪片5mg,每日2次)及对照组(26例,口服安慰剂每日2次),疗程共12周。以头痛发作频率为主要评定指标,发作持续时间、程度、伴随症状及头痛综合评分为次要评定指标;并记录不良反应。结果(1)治疗组治疗第4周、第8周及第12周末时,头痛发作频率、头痛持续时间、头痛程度、伴随症状及头痛综合评分较对照组极显著降低(均P<0.01);(2)总有效率治疗组为81.5%,极显著优于对照组(7.7%)(P<0.005)。两组治疗期间均无严重不良反应。结论国产盐酸洛美利嗪是安全有效防治偏头痛发作的药物。
Objective To evaluate the efficacy and safety of domestic Lomerizine hydrochloride in the treatment of migraine. Methods A randomized, double-blind, placebo-controlled study was performed. The 53 patients enrolled were randomly assigned to receive either Lomerizine Hydrochloride (n = 27) or Lomerizine hydrochloride (5 mg twice daily) (26 cases, oral placebo twice daily) for 12 weeks. Headache attack frequency as the main evaluation index, duration of attack, degree, accompanying symptoms and headache comprehensive score as secondary evaluation indicators; and record adverse reactions. Results (1) At the 4th week, the 8th week and the 12th weekend, the frequency of headache attacks, the duration of headache, the degree of headache, the accompanying symptoms and headache in treatment group were significantly lower than those in control group (all P <0.01). (2) The total effective rate in the treatment group was 81.5%, significantly higher than that in the control group (7.7%) (P <0.005). There was no serious adverse reaction during the two groups. Conclusion Domestic Lomerizine hydrochloride is a safe and effective drug for preventing migraine attacks.