摘要
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 study the efficacy and safety of domestic-made Lomerizine hydrochloride for treating migraine, Methods 53 patients with migraine were randomly divided into Lomerizine hydrochloride group （27 cases） and control group （26 cases）, and treated with Lomerizine hydrochloride or placebo orally respectively . The total follow-ups were 12 weeks, Headache frequency was served as main evaluation index, and duration and degree of headache, simultaneous complications and headache scores as secondary evaluation indexes, Results （ 1 ） The 4, 8 and 12 weeks after treatment, the scores of headache frequency, lasting time of headache, degree of headache, accompany symptom and total scores in Lomefizine hydrochloride group were decreased significantly compared with control group （ all P 〈 0. 01 ）. （ 2 ） The total effective rates of Lomerizine hydrochloride group and control group were 81.5% and 7.7% , respectively （P 〈0. 005 ）. Serious adverse effect was not observed in both groups. Conclusion Domestic-made Lomefizine hydrochlofide is an effective and safe agent for migraine treatment.
出处
《临床神经病学杂志》
CAS
北大核心
2006年第6期460-462,共3页
Journal of Clinical Neurology
关键词
盐酸洛美利嗪
偏头痛
Lomerizine hydrochloride
migraine
