镇脑宁胶囊治疗高血压性头痛的临床疗效及经济学分析

Clinical efficacy and pharmacoeconomic analysis of Zhennaoning Capsule in treatment of hypertension headache

目的探讨镇脑宁胶囊治疗高血压性头痛的临床疗效和安全性,并进行药物经济学评价。方法将243例高血压性头痛患者随机分为治疗组(120例)和对照组(123例),治疗组口服镇脑宁胶囊,4粒/次,3次/d;同时口服养血清脑颗粒模拟剂,1袋/次,3次/d。对照组口服养血清脑颗粒,1袋/次,3次/d;同时口服镇脑宁胶囊模拟剂,4粒/次,3次/d。患者参与该临床试验期间继续服用降压药,但禁止使用其他对高血压性头痛有作用的中药及治疗肾阴虚的药物。采用单盲、平行性对照研究,疗程均为8周。观察2组疗效及不良反应,并运用成本–效果分析法进行药物经济学评价。结果 2组患者的临床疗效及不良反应发生率差异均无统计学意义,但治疗组成本–效果比明显低于对照组(P<0.01)。结论镇脑宁胶囊治疗高血压头痛疗效较好,临床应用安全,经济学优势更加明显。

Objective To evaluate the clinical efficacy and safety of Zhennaoning Capsule （ZC） in the treatment of hypertension headache and to evaluate its pharmacoeconomics. Methods The patients （243 cases） with hypertension headache were randomly divided into the treatment （120 cases） and control （123 cases） groups. The patients in the treatment group were po administered with ZC, 4 capsules once, three times daily, and at the same time, they were po administered with Yangxue Qingnao Granules （YQG） simulated agent, 1 bag once, three times daily. Patients in the control group werepo administered with YQG, 1 bag once, three times daily, and at the same time, they were po administered with ZC simulated agent, 4 capsules once, three times daily. All the patients continued taking antihypertensive drugs, but the Chinese materia medica for hypertension headache and kidney yin dificiency were prohibited. The course of the treatment was eight weeks, and the single-blind and parallel-controlled contrast studies were adopted. The clinical efficacy and safety of the two groups were observed and evaluated by the cost-effectiveness method of pharmacoeconomics. Results There were no differences between the two groups on the clinical efficacy and safety, but the cost-effectiveness of the treatment group was lower than that of the control group （P 〈 0.01）. Conclusion Compared with YQG; ZC is better in the treatment of hypertension headache. The therapeutic effect is reliable and safe and has more obvious economic advantages.