天舒胶囊预防性治疗偏头痛

Clinical Research of Prophylactic Treatment of Migraine on Tianshu Capsule

目的:探讨天舒胶囊预防性治疗偏头痛的有效性及安全性。方法:采用多中心分层区组随机、双盲、阳性药平行对照研究。600例偏头痛患者分成3组,试验组口服天舒胶囊每次4粒,每日3次;对照组1口服盐酸氯柱利嗪胶囊,每次2粒,每日2次;对照组2口服元胡止痛胶囊每次4粒,每日3次。治疗时间均为12周。初诊首日(入组时)、第4,8,12周末各随访1次,记录患者头痛发作的次数、持续时间、患者头痛程度视觉模拟(VAS)评分、中医证候以及不良事件的发生情况。结果:治疗12周末与治疗前相比,天舒胶囊改善偏头痛(瘀血挟肝阳上亢证)的头痛疗效、中医证候疗效,减少头痛发作频率方面与盐酸氟桂利嗪胶囊疗效相当,并明显优于元胡止痛胶囊。天舒胶囊服药后不良反应发生率明显低于盐酸氟桂利嗪胶囊,并与元胡止痛胶囊相当。结论:天舒胶囊是一种安全性较好,能有效治疗和预防偏头痛发作的药物。

Objective： To investigate the efficacy and safety of Tianshu capsule in prophylactic treatment of migraine. Method： A multicenter stratified block randomized, double blind, positive drug parallel controlled clinical trials were conducted. 600 cases of migraine patients were divided into three groups, the treatment group was treated with oral Tianshu capsule 4 pills,tid; the control group was treated with oral sibelium capsules 2 pills, bid; the other control group was treated with oral Yuanhu Zhitong capsule 4 pills, tid. The treatment time was 12 weeks. Headache frequency, duration, VAS score of headache severity, symptom and adverse events of patients were recorded in follow-up study respectively on the First day, fourth weeks, eighth weeks, Twelfth weekend. Result： After 12 weeks treatment, Tianshu capsule improved the efficacy on relieving headache and TCM syndromes （syndrome of blood stasis mingled with hyperactivity of liver Yang）, reduced headache frequency compared with those before treatment The curative effect was equivalent with flunarizine hydrochloride capsules, better than Yuanhu Zhitong capsule control group. The incidence of adverse reactions was equivalent with Yuanhu Zhitong capsule control group, lower than flunarizine hydrochloride. Conclusion： Tianshu capsule is the effective and safety drug for treatment and prevention of migraine.