都梁软胶囊对风寒瘀血型偏头痛患者脑部血流动力学及血管活性因子的影响

Effects of Duliang Soft Capsule( 都梁软胶囊) on Brain Hemodynamics and Vasoactive Factors in Migraine Patients with Cold-coagulation and Blood-stasis Syndrome

目的:观察都梁软胶囊对风寒瘀血型偏头痛患者的疗效、安全性及脑部血流动力学和血管活性因子的影响。方法:82例风寒瘀血型偏头痛患者随机分为观察组(44例)和对照组(38例)。对照组口服麦角胺咖啡因片、尼莫地平片、盐酸氟桂利嗪胶囊(疗程6个月)及电针治疗(疗程30天);观察组在对照组治疗的基础上加服都梁软胶囊(疗程6个月)。监测两组患者偏头痛发作频率、持续时间、严重程度、伴随症状,于治疗3天后统计发作期疗效,于治疗前偏头痛发作期和治疗1个月后检测经颅多普勒脑血流动力学指标及血管活性因子,治疗6个月后统计预防性治疗的疗效及安全性指标。结果:观察组患者发作期的显效率和总有效率均高于对照组(均P<0.05),观察组患者预防性治疗的治愈率和总有效率均高于对照组(均P<0.05);治疗后两组患者各颅内动脉(ACA、MCA、PCA、VA、BA)的平均血流速度均比治疗前显著降低(均P<0.01),而观察组平均血流速度降低更明显(P<0.01或P<0.05);治疗后两组患者的ET-1、CGRP水平较治疗前降低(均P<0.01),NO、5-HT水平较治疗前升高(均P<0.01),而观察组患者的各血管活性因子的改善更明显(均P<0.05);观察组患者未出现与都梁软胶囊相关的不良反应。结论:都梁软胶囊治疗风寒瘀血型偏头痛安全有效,能够改善脑部血流动力学紊乱,可能通过影响ET-1、NO、5-HT、CGRP水平起作用。

Objective： To study the effects of Duliang soft capsule on efficacy,safety,brain hemodynamics and vasoactive factors in migraine patients with cold- coagulation and blood- stasis syndrome. Methods： 82 migraine patients with cold- coagulation blood- stasis syndrome were randomly divided into observation group（ 44cases） and control group（ 38 cases）. The control group was treated with Ergotamine and caffeine tablets,nimodipine tablets,flunarizine hydrochloride capsules（ the course of treatment was 6 months）,and electroacupuncture therapy（ the course of treatment was 30 days）; the observation group was treated with Duliang soft capsule based on the treatment of the control group（ the course of treatment was 6 months）. To monitor migraine frequency,duration,severity,with symptoms of two groups of patients,the therapeutic indexes in the acute outbreak were calculated after 3 days of treatment,the indexes of transcranial doppler cerebral hemodynamics and vasoactive factors were determined before（ the acute outbreak） and after one month of treatment,the indexes of curative effect and safety of preventive treatment were calculated after 6 months of treatment. Results： The obvious effective rate and total effective exacerbation of observation group was higher than that of control group in the acute outbreak（ χ2=4. 7731,6. 4302,all P〈0. 05）,the cure rate and total effective in preventive treatment of observation group was higher than those of control group（ χ2= 6. 0169,5. 3788,all P〈0. 05）; Mean blood flow velocity of the intracranial arteries（ ACA,MCA,PCA,VA,BA） in two groups after treatment were significantly lower compared with before treatment（ all P〈0. 01）,the average blood flow velocity decreased more significantly in the observation group（ P〈0. 01 or P〈0. 05）; ET- 1,CGRP levels in the two groups after treatment were significantly lower than before treatment（ all P〈0. 01）,NO and 5- HT levels in the two groups after treatment were significantly higher than before treatment（ all P〈0. 01）,all vasoactive factors improved more significantly in the observation group（ all P〈0. 05）; patients in observation group had no adverse reactions associated with Duliang soft capsule. Conclusions： Duliang soft capsule is a safe,effective medicine in treatment of migraine patients with cold- coagulation and blood- stasis syndrome,can improve the cerebral hemodynamic disorder,probably play a role by affecting ET- 1,NO,5- HT,CGRP levels.