复方高滋斑片治疗偏头痛(肝阳上亢证)的有效性及安全性临床研究

Clinical Study on the Efficacy and Safety of Compound High Ziban Tablets in the Treatment of Migraine (Liver Yang Hyperactivity Syndrome)

摘要: 目的：以阳性药物盐酸氟桂利嗪胶囊作为对照对复方高滋斑片治疗偏头痛(肝阳上亢证)的有效性及安全性进行评价。方法：选取2022年5月至2023年10月就诊于神经内科住院处的符合先前制订的纳入标准和排除标准的72名肝阳上亢型偏头痛的患者。按随机信封法进行分组，每组各32例。对照组给予盐酸氟桂利嗪胶囊进行治疗，试验组给予复方高滋斑片进行治疗，干预时间为1个月。测定两组用药前及用药后4周、停药后4周的头痛计分、疼痛视觉模拟评分(VAS)、总有效率、不良反应发生率。结果：两组用药后4周、停药后4周的头痛计分、疗效、疼痛视觉模拟评分(VAS)、总有效率、不良反应发生率比较，试验组均优于对照组(P < 0.05)。结论：复方高滋斑片治疗偏头痛(肝阳上亢证)的疗效显著，值得临床推广并使用。

Abstract: Objective: To evaluate the effectiveness and safety of the compound high Ziban tablets in the treatment of migraine (liver yang hyperactivity syndrome) using the positive drug Flunarizine Hydrochloride Capsules as a control. Method: 72 patients with liver yang hyperactive migraine who met the previously established inclusion and exclusion criteria and were admitted to the neurology department from May 2022 to October 2023 were selected. Divide into groups using the random envelope method, with 32 cases in each group. The control group was treated with Flunarizine Hydrochloride Capsules, while the experimental group was treated with compound high Ziban tablets for one month of intervention. Measure the headache score, pain visual analogue scale (VAS), total effective rate, and incidence of adverse reactions in two groups before and 4 weeks after medication, and 4 weeks after discontinuation of medication. Result: The headache score, efficacy, pain visual analogue scale (VAS), total effective rate, and incidence of adverse reactions were compared between the two groups at 4 weeks after medication and 4 weeks after discontinuation, which showed that the experimental group was superior to the control group (P < 0.05). Conclusion: The therapeutic effect of compound high Ziban tablets on migraine (liver yang hyperactivity syndrome) is significant and worthy of clinical promotion and use.