西北五省区调节血脂类药品临床综合评价研究  

Study on the clinical comprehensive evaluation of blood lipid-regulating drugs in five provinces and regions in Northwest China

作　　者：乔元 赵航[1,2,3,4,5] 杜嘉晰 满靖怡 许森 马方怡 胡书琛 彭晋 姜明欢 赵明月 方宇 QIAO Yuan;ZHAO Hang;DU Jiaxi;MAN Jingyi;XU Sen;MA Fangyi;HU Shuchen;PENG Jin;JIANG Minghuan;ZHAO Mingyue;FANG Yu(Dept.of Pharmacy Administration and Clinical Pharmacy,School of Pharmacy,Xi’an Jiaotong University,Xi’an 710061,China;Institute of Drug Safety and Monitoring,Academy of Pharmaceutical Science and Technology,Western China Scientific and Technological Innovation Harbor,Xi’an 710061,China;Center for Drug Safety and Policy Research,Xi’an Jiaotong University,Xi’an 710061,China;Northwest Medicine Clinical Comprehensive Evaluation Center,Xi’an 710061,China;Northwest China Chapter,International Society for Pharmacoeconomics and Outcomes Research,Xi’an 710061,China)

机构地区：[1]西安交通大学药学院药事管理与临床药学系,西安710061 [2]中国西部科技创新港药物科学与技术研究院药物安全与监控研究所,西安710061 [3]西安交通大学药品安全与政策研究中心,西安710061 [4]西北药品临床综合评价中心,西安710061 [5]国际药物经济与结果研究学会中国西北分会,西安710061

出　　处：《中国药房》2023年第10期1165-1171,共7页China Pharmacy

基　　金：陕西省重点研发计划项目(No.2020GXLH-Y-004)。

摘　　要：目的探索调节血脂类药品临床综合评价的标准化评价流程,并对不同作用机制的调节血脂类药品进行临床综合评价的快速评估,为医疗机构的药品目录遴选和合理用药提供依据。方法参照药品临床综合评价管理指南等指南和共识,采用文献研究法、专家访谈法、德尔菲专家咨询法等,围绕技术评价和政策评价两条主线,构建多维度、多准则的调节血脂类药品临床综合评价指标体系及量化评分表;依托西北五省区21家三级甲等医疗机构,对13个不同作用机制的调节血脂类药品进行评分,形成综合评价结果。结果构建了西北五省区调节血脂类药品临床综合评价指标体系及相应的快速评价量化评分表,其中技术性评价部分包括一级指标6个,二级指标13个,三级指标34个,共计110分;政策评价部分包括一级指标4个,二级指标6个,共计40分(部分药品总分为30分);总分为150分(或140分)。评分结果显示,得分最高的为阿托伐他汀,其次为瑞舒伐他汀和辛伐他汀。结论他汀类调节血脂药物仍为血脂异常患者药物治疗的基石。本研究所构建的快速评价量化评分表全面系统、可操作性强,评价流程可为探索药品临床综合评价的标准化路径及质量控制机制提供经验参考。OBJECTIVE To explore standardized evaluation process for clinical comprehensive evaluation of blood lipidregulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions.METHODS Referring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs,the methods such as literature research,expert interviews,and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation.Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result.RESULTS The clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions.The technical evaluation section included 6 primary indicators,13 secondary indicators,and 34 tertiary indicators,totaling 110 points.The policy evaluation section included 4 primary indicators and 6 secondary indicators,with a total score of 40 points(30 points for some drugs)and a total score of 150 points(or 140 points).The scoring results showed that the highest score was atorvastatin,followed by rosuvastatin and simvastatin.CONCLUSIONS Statins are still the cornerstone of drug therapy for patients with dyslipidemia;the rapid evaluation quantitative scoring table constructed in this study is comprehensive,systematic and operable.The evaluation process in this study can provide empirical references for other groups to exploring the standardized

关 键 词：药品临床综合评价 评价机制 质量控制 指标体系 快速评价 调节血脂药 

分 类 号：R972.6[医药卫生—药品]