摘要
目的:盐酸洛美利嗪作为治疗偏头痛的药物,已在国外上市,但未在中国上市销售,为指导临床医师合理用药,评价国产盐酸洛美利嗪治疗偏头痛的疗效及安全性。方法:以在大坪医院神经内科门诊就诊的偏头痛患者为研究对象,按公认统一的纳入标准及排除标准,采用随机、双盲、以盐酸氟桂利嗪为阳性对照药进行试验,共入选病例65例,完成病例59例,分试验组(盐酸洛美利嗪)和对照组(盐酸氟桂利嗪),其中试验组31例,对照组28例。清洗期每日早晚给予安慰剂两粒,分早餐后、睡前服用。治疗期,试验组患者早餐后服用盐酸洛美利嗪胶囊和安慰剂各1粒,睡前服盐酸洛美利嗪胶囊和安慰剂各1粒;对照组早餐后服安慰剂2粒,睡前服盐酸氟桂利嗪胶囊2粒,疗程共56d。根据头痛评分变化判断疗效,计算有效率,并记录不良反应。结果:试验组的总有效率为78.13%;阳性对照组总有效率为75.86%。两组差异无显著性意义。不良反应发生率分别为9.67%和6.90%,差别差异无显著性意义,未发现严重的不良反应。结论:国产盐酸洛美利嗪治疗偏头痛安全有效。
AIM:As a kind of drug for migraine,lomerizine hydrochloride has market abroad for a long time,but it is not sold in China.The efficacy and safety of lomerizine hydrochloride for migraine are investigated in order to introduce reasonable usage for clinicians. METHODS:Inpatients with migraine were selected from the Department of Neurology of our hospital,and were in accordance with generally accepting and excluding criteria.Fifty-nine patients among 65 patients were divided into experimental group(lomerizine hydrochloride) and control group(flunari zine hydrochloride),including 31 patients and 28 patients respectively,who were tested with randomized,double blind and flunarizine hydrochloride as positive control medicine.All patients took placebo orally with two granulations after breakfast and before sleeping respectively in cleaning phase.In therapy phase,the patients in experimental group took lomerizine hydrochloride capsule and placebo orally with one granulation respectively after breakfast and before sleeping.However,patients in control group took placebo orally with two granulations after breakfast and flunarizinedithdrochloride orally with two granulations before sleeping.The total course was 56 days.The effect was estimated,the effective rate calculated and the poor reaction recorded according to the changes of headache scores. RESULTS:The total effective rate was 78.13%for experimental group and 75.86%for positive control group.There was no significant difference in these two groups.The incidence rate of bad effect was 9.67%and 6.90%in these two groups respectively.The serious was not found. CONCLUSION:Domestic lomerizinedihydrochloride is an effective and safe agent for migraine.
出处
《中国临床康复》
CSCD
2004年第31期6869-6871,共3页
Chinese Journal of Clinical Rehabilitation
