布洛芬软胶囊治疗偏头痛的临床试验  

Clinical Trial of Ibuprofen Soft Capsule in Treating Migraine

作　　者：李健华[1] 顾学兰[1] 许亦群[1] 赵忠新[2] 狄晴[3] 谭兰[4] 

机构地区：[1]江苏先声药物研究有限公司,南京210042 [2]上海长征医院,上海200003 [3]南京医科大学附属脑科医院,南京210029 [4]青岛大学医学院附属医院,青岛266003

出　　处：《江苏药学与临床研究》2005年第6期29-31,共3页Jiangsu Pharmacertical and Clinical Research

摘　　要：目的评价布洛芬软胶囊治疗偏头痛急性发作的疗效和安全性。方法随机、双盲、安慰剂交叉对照的多中心临床试验。共入组偏头痛病例120例,实际完成病例数为111例,其中先服布洛芬后服安慰剂组55例;先服安慰剂后服布洛芬组56例。治疗前两组的一般资料、临床评价和实验室指标无显著性差异。结果布洛芬组和安慰剂组2小时内头痛消失率分别为(48.65±4.74)%和(19.82±3.78)%(P<0.01)。布洛芬组和安慰剂组2小时内头痛缓解率分别为(79.28±3.85)%和(45.05±4.72)%(P<0.01)。结论布洛芬治疗偏头痛安全性好,可作为治疗偏头痛急性发作的有效药物。AIM To evaluate the efficacy and safety of ibuprofen soft capsule in treating acute migraine attacks. METHODS A multicenter double- blind randomized placebo controlled crossover clinical trial was conducted. One hundred and twenty patients with migraine were enrolled, with 111 patients completed the whole follow-up, including 55 patients in ibuprofen-placebo group and 56 patients in placeboibuprofen group. Two groups were comparled on demography. RESULT Treatment of migraine with ibuprofen achieved （48.65 ± 4.74） % 2 h pain-free response rate and that of the placebo group only with （19.82 ± 3.78）%（ P 〈 0.01 ）.2 h pain-lowing rates of the two groups were （ 79.28 ± 3.85 ） % and （45.05 ± 4.72） % （ P 〈 0.01 ）. CONCLUSION Ibuprofen may significantly improve the symptoms of the patient with acute migraine and is safe, being an ideal choice in treating acute attack.

关 键 词：偏头痛 多中心临床试验 双盲法 随机交叉对照试验 布洛芬软胶囊 

分 类 号：R969.4[医药卫生—药理学]