摘要
通过安全性、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,体现碟脉灵^(■)苦碟子注射液治疗脑梗死的优势和特点。该研究采用定性与定量相结合的评价方法,基于循证医学、流行病学、临床医学、循证药学、药物经济学、数理统计学、卫生技术评估(HTA)等方法,通过专家对准则层、指标层赋予权重,采用多准则决策分析(MCDA)模型及CSC v2.0软件进行计算,评估碟脉灵^(■)苦碟子注射液的临床价值。根据现有证据显示,碟脉灵^(■)苦碟子注射液上市后开展了主动监测以及多项RCTs,总不良反应发生率为0.099%,药品不良反应(ADR)发生率属罕见,安全性评价为B级。有效性证据价值显示碟脉灵^(■)苦碟子注射液联合常规西药提高脑梗死急性期神经功能缺损评分、总有效率以及日常生活质量明显优于常规西药治疗组,且证据级别较高,评价为A级。经济学研究结果显示碟脉灵^(■)苦碟子注射液联合常规西药治疗与西药常规治疗对比,碟脉灵^(■)苦碟子注射液组增量效应较大,但成本一般,经济学报告的总体质量评价结果基本明确,评价为B级。创新性评价为B级。该药用法较易,无特殊技术和管理要求,易于医护人员临床操作,患者亦可接受,对临床医生、护士、药师以及使用该药品的患者具有较好的适宜性,评价为B级。可负担性与可获得性较好,由于价格水平在同类药品属于中等,评价为B级。碟脉灵^(■)苦碟子注射液对急性脑梗死火毒证的临床症状及神经功能缺损改善明显,且该药属于民族药,开展了大样本的主动监测研究,有丰富的人用经验,因此中医药特色评价为A级。综合各难度证据评价碟脉灵^(■)苦碟子注射液为A类,建议可直接按程序转化为基本临床用药管理的相关政策结果。
Clinical comprehensive evaluation was conducted in"6+1"dimensions(safety,effectiveness,economy,innovation,suitability,accessibility,and characteristics of traditional Chinese medicine)to reflect the advantages and characteristics of Diemai-ling^(■)Kudiezi Injection in the treatment of cerebral infarction.This study adopted a combination of qualitative and quantitative evaluation methods.Based on the methodologies of evidence-based medicine,epidemiology,clinical medicine,evidence-based pharmacy,pharmacoeconomics,mathematical statistics,and health technology assessment(HTA),experts gave weight to the criterion layer and index layer,and multi-criteria decision analysis(MCDA)model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing^(■)Kudiezi Injection.The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs)have been carried out after the listing of Diemailing^(■)Kudiezi Injection.Since the total incidence of adverse reactions is 0.099%and the incidence of adverse drug reactions(ADR)is rare,the safety evaluation is grade A.The evidence value of effectiveness demonstrated that Diemailing^(■)Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction,which is superior to that in the conventional western medicine treatment group,and the level of evidence is high.Therefore,its efficacy is assessed as grade A.According to the results of economic research,when Diemailing^(■)Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment,the Diemailing^(■)Kudiezi Injection group has a greater incremental effect,but the cost is affordable.Given the overall quality evaluation results of economic report is clear,it is evaluated as grade B.The innovation is grade A.The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements.Since the drug exhibits good suitability for clinicians,nurses,pharmacists,and patients,it is evaluated as grade B.Considering its moderate price among similar drugs and good affordability and availability,it is evaluated as grade B.Diemailing^(■)Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction,and this medicine belongs to ethnic medicine.Large-sample active monitoring research has been conducted with rich experience in human use.Therefore,the characteristics of traditional Chinese medicine are evaluated as grade A.The comprehensive clinical evaluation of Diemailing^(■)Kudiezi Injection is class A.We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.
作者
刘福梅
谢雁鸣
王志飞
张强
崔鑫
LIU Fu-mei;XIE Yan-ming;WANG Zhi-fei;ZHANG Qiang;CUI Xin(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第23期6105-6113,共9页
China Journal of Chinese Materia Medica
基金
中国中医科学院科技创新工程重大攻关项目(CI2021A00702)
国家重点研发计划项目(2018YFC1707400)。
关键词
碟脉灵^(■)苦碟子注射液
脑梗死
临床证据
价值评估
多准则决策分析
Diemailing^(■)Kudiezi Injection
cerebral infarction
clinical evidence
value evaluation
multi-criteria decision analysis(MCDA)
