盐酸洛美利嗪治疗偏头痛的疗效及安全性研究

Study on efficacy and safety of lomerizine hydrochloride tablet in treatment of migraine

目的探讨盐酸洛美利嗪治疗偏头痛的疗效及安全性。方法 60例偏头痛患者随机分为A、B两组,每组30例。两组均给予盐酸洛美利嗪和安慰剂进行为期30周的双盲自身交叉对照试验。记录患者治疗第2、8、14、16、22、28、30周末的头痛发作频率,进行偏头痛致残评定量表(MIDAS)评定。结果与治疗前比较,A组第8周的MIDAS2～5、第14、16周的MIDAS1～5和第22周的MIDAS1～4评分显著下降(均P<0.05);B组第14周MIDAS1～3及第16～30周的MIDAS1～5评分显著下降(均P<0.05)。A组第14周的头痛发作频率显著低于B组,B组第28周头痛发作频率显著低于A组(均P<0.01)。A组第14周头痛发作强度改善率、发作频率改善率显著高于第28周;B组第28周显著高于第14周(P<0.05～0.001)。A组治疗第14周时总有效率显著高于B组;B组治疗第28周时总有效率显著高于A组(均P<0.001)。两组患者治疗期间均无严重不良反应。结论盐酸洛美利嗪预防性治疗偏头痛安全、有效,停药后疗效仍有一定持久性。

Objective To investigate the curative effect and safety of lomerizine hydrochloride tablet in treatment of migraine. Methods Sixty patients with migraine were divided into A and B groups randomly, 30 cases in each group. The two groups were treated with lomerizine hydrochloride tablet and placebo for 30 weeks, which was carried out through self-crossover double-blind controlled clinical study. The headache frequency was recorded at the second, eighth, fourteenth, sixteenth, twenty-second, twenty-eighth, thirtieth week, and the score of migraine disability assessment scale （MIDAS） was assessed. Results Compared with pre-treatment, the scores of MIDAS2 - 5 at eighth week, MIDAS1 -5 at fourteenth and sixteenth week and MIDAS1 -4 at twenty-second week in A group were significantly decreased （ all P 〈 0. 05 ） ; and MIDAS1 - 3 at fourteenth week, MIDAS1 - 5 at sixteenth - thirtieth week in B group were significantly decreased （ all P 〈 0. 05 ）. The headache frequency at fourteenth week in A group was significantly decreased than B group; and at twenty-eighth week in B group was significantly decreased than A group （ all P 〈 0. 01 ）. The improvement rate of headache strength and headache frequency in A group at fourteenth week were significantly increased than those at twenty-eighth week; and in B group, which at twenty-eighth week were significantly increased than those at fourteenth week （ P 〈 0. 05 - 0. 001 ）. The total effective rate at fourteenth week in A group were significantly higher than B group; and in B group, which at twenty-eighth weekwas significantly higher than A group （all P 〈 0. 001 ）. The patients in the two groups had no severe bad reaction during the course of treatment. Conclusion It is safe and effective to use lomerizine hydrochloride tablet in the preventive treatment of migraine, and curative effect will still to remain for some time after drug withdrawa.