天舒胶囊治疗偏头痛(瘀血阻络证、肝阳上亢证)的临床综合评价

Clinical comprehensive evaluation of Tianshu Capsules in treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang)

通过系统梳理天舒胶囊治疗偏头痛(瘀血阻络证、肝阳上亢证)的现有研究,从安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色(“6+1”维度)进行临床综合评价,体现天舒胶囊的优势和特点,明确临床精准定位。采用卫生技术评估的方法,运用多准则决策分析(MCDA)模型和CSC v2.0软件计算各维度的价值,结果由高到低分为A、B、C、D 4个等级。天舒胶囊已知风险较小,基于现有研究,风险可控,安全性评为A级。该药治疗偏头痛(瘀血阻络证、肝阳上亢证)临床意义明显,有效性评为A级。经济性结果较明确,经济性评为B级。临床创新性、服务体系创新性及产业创新性3个方面均较好,创新性评为A级。该药可满足医护及患者的临床用药需求,适宜性评为A级。药品价格水平、可负担性和可获得性3个方面均较好,可及性评为A级。组方起源于经典名方《圣济总录》的大芎丸,已报道临床试验中使用天舒胶囊的患者4675例,人用经验丰富,中医药特色评为B级。药品法定信息符合国家标准规定,非法定信息比较规范、准确。综合各维度证据评价结果,天舒胶囊治疗偏头痛(瘀血阻络证、肝阳上亢证)的临床价值综合评为A类,依据国家卫生健康委发布的《药品临床综合评价管理指南(2021年版试行)》,建议可按程序转化为基本临床用药管理的相关政策结果。

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals,syndrome of ascendant hyperactivity of liver Yang),and conducted comprehensive clinical evaluation through"6+1"dimensions of safety,effectiveness,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine(TCM)to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules.The value of each dimension was calculated via health technology assessment,the multi-criteria decision analysis(MCDA)mo-del and CSC v2.0 software.The results were graded into four levels of A,B,C,or D from high to low.According to the available studies,Tianshu Capsules had low and controllable risks,with the safety rated as A.The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals,syndrome of ascendant hyperactivity of liver Yang),with the effectiveness rated as A.It has clear economic results,with the economy rated as B.The clinical innovation,service system innovation,and industrial innovation are all good,and thus the innovation of Tianshu Capsules is grade A.The drug can meet clinical medication demand of medical care and patients,and thus its suitability is grade A.In view of the reasonable drug price,affordability,and availability,the accessibility is grade A.The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit.In clinical trials,4675 patients have used Tianshu Capsules,which indicates rich experience in human administration,and the characteristics of traditional Chinese medicine is grade B.The statutory drug information complies with national stan-dards,and the non-statutory information is standard and accurate.Based on the comprehensive evaluation results of various dimensions of evidence,the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang)is class A.According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021)issued by the National Health Commission of the People′s Republic of China,we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.