蝎蜈胶囊治疗肝风挟瘀型无先兆偏头痛的临床研究

Clinical research of “Xiewu Capsule” in the treatment of migraine without aura of liver-wind and blood stasis syndrome

目的:评价蝎蜈胶囊治疗肝风挟瘀型无先兆偏头痛的疗效和安全性。方法:采用随机双盲安慰剂对照的研究方法,纳入肝风挟瘀型无先兆偏头痛患者120例,将患者随机分为治疗组(60例)和对照组(60例)。治疗组采用蝎蜈胶囊口服治疗,对照组采用蝎蜈胶囊安慰剂口服治疗,连续服药12周,停药4周后随访。治疗12周后比较两组患者的头痛发作次数、头痛程度视觉模拟评分(VAS)、头痛持续时间、止痛药暴露程度、应答者比率,同时停药4周后随访,比较两组患者的头痛发作次数。评价两组患者的中医证候疗效及治疗的安全性。结果:治疗后,两组患者的头痛发作次数、头痛VAS评分较治疗前均明显减少(P<0.05),且治疗组患者的头痛发作次数、头痛VAS评分较对照组明显减少(P<0.05)。停药4周后随访,两组患者的头痛发作次数较治疗前亦有减少(P<0.05),且治疗组患者的头痛发作次数较对照组有明显减少(P<0.05)。治疗后,治疗组中服用止痛药的患者例数较治疗前显著减少(P<0.05),且治疗组中服用止痛药的患者例数明显少于对照组(P<0.05)。治疗12周时,治疗组的应答者比率为90.0%,对照组为31.7%,其差异具有统计学意义(P<0.05)。治疗后,治疗组的中医证候疗效总有效率为78.3%,对照组为35.0%,治疗组疗效优于对照组(P<0.05)。治疗全程,两组均未发生明显的不良反应事件。结论:蝎蜈胶囊治疗肝风挟瘀型无先兆偏头痛安全有效,能够预防偏头痛的发生。

Objective: To evaluate the efficacy and safety of"Xiewu Capsule"in treating migraine without aura of liver-wind and blood-stasis syndrome. Methods: The randomized,placebo controlled,double-blind study was conducted,and 120 migraine patients without aura of liver-wind and blood-stasis syndrome were selected. All the patients were randomly divided into the treatment group( 60 cases) and the control group( 60 cases). The patients in the treatment group were treated with"Xiewu Capsule"orally and the patients in the control group were treated with placebo orally,with a course of 12 weeks,and then followed-up after 4 weeks of withdrawal. Twelve weeks after treatment,the attack times,visual analogue scale( VAS) score,duration time of migraine,the exposure rate of anodynes and the responder ratio were compared. After 4 weeks of withdrawal,the attack times of migraine was also compared. The Chinese medical syndrome efficacy and the safety were evaluated. Results: After treatment,the attack times and VAS score of migraine in both groups were significantly decreased( P<0.05),and the attack times and VAS score of migraine in the treatment group were lower than those in the control group( P<0.05). Followed-up after 4 weeks of withdrawal,the attack times of migraine in both groups was also decreased( P<0.05),and the attack times of migraine in the treatment group were lower than those in control group( P < 0.05). After treatment,the number of patients who took anodynes in the treatment group was markedly decreased( P < 0.05),and the number of patients who took anodynes in the treatment group was less than that in the control group( P<0.05). Twelve weeks after treatment,the responder ratio of the treatment group was 90. 0% and the control group was 31. 7%,with statistical difference between the two groups( P < 0.05). After treatment,the total effective rates on Chinese medical syndrome of the treatment group and the control group were 78.3% and 35.0%,and the efficacy of the treatment group was better than that of the control group( P<0.05). Both groups showed no obvious adverse events in the course of treatment. Conclusion: "Xiewu Capsule"is effective and safe in the treatment of migraine without aura of liver-wind and blood-stasis syndrome and can effectively prevent migraine.