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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
Published:30 May 2023,
Received:11 October 2022,
Revised:31 March 2023,
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乔元,赵航,杜嘉晰等.西北五省区调节血脂类药品临床综合评价研究 Δ[J].中国药房,2023,34(10):1165-1171.
QIAO Yuan,ZHAO Hang,DU Jiaxi,et al.Study on the clinical comprehensive evaluation of blood lipid-regulating drugs in five provinces and regions in Northwest China[J].ZHONGGUO YAOFANG,2023,34(10):1165-1171.
乔元,赵航,杜嘉晰等.西北五省区调节血脂类药品临床综合评价研究 Δ[J].中国药房,2023,34(10):1165-1171. DOI: 10.6039/j.issn.1001-0408.2023.10.03.
QIAO Yuan,ZHAO Hang,DU Jiaxi,et al.Study on the clinical comprehensive evaluation of blood lipid-regulating drugs in five provinces and regions in Northwest China[J].ZHONGGUO YAOFANG,2023,34(10):1165-1171. DOI: 10.6039/j.issn.1001-0408.2023.10.03.
目的
2
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
2
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
2
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
2
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
2
To explore standardized evaluation process for clinical comprehensive evaluation of blood lipid-regulating 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
2
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
2
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
2
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 path and quality control mechanism of clinical comprehensive evaluation of drugs.
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
evaluation mechanismquality controlindex systemrapid evaluationblood lipid-regulating drugs
国家卫生健康委. 关于开展药品使用监测和临床综合评价工作的通知:国卫药政函〔2019〕80号[EB/OL].(2019-04-09)[2022-09-24]. http://www.nhc.gov.cn/yaozs/pqt/201904/31149bb1845e4c019a04f30c0d69c2c9.shtml?from= timeline&isappinstalled=0http://www.nhc.gov.cn/yaozs/pqt/201904/31149bb1845e4c019a04f30c0d69c2c9.shtml?from=timeline&isappinstalled=0.
赵瑞玲,黄亚云,张夏丽,等. 儿童退热药布洛芬制剂临床综合评价指标体系的构建[J]. 中国医院药学杂志,2022,42(7):758-761.
石秀园,赵锐,李璠,等. 构建我国药品临床综合评价工作机制的思考[J]. 中国药房,2020,31(23):2828-2833.
王海银,符雨嫣,覃肖潇,等. 药品临床综合评价:保障临床基本用药合理使用[J]. 中国卫生,2021(8):72-73.
赵锐,石秀园,胡若飞,等. 省域药品临床综合评价工作的关键环节探讨[J]. 卫生经济研究,2022,39(5):17-20.
赵锐,石秀园,刘春平,等. 基于因子分析法的药品临床综合评价决策转化影响因素分析[J]. 中国卫生经济,2021,40(5):61-64.
诸骏仁,高润霖,赵水平,等. 中国成人血脂异常防治指南:2016年修订版[J]. 中国循环杂志,2016,31(10):937-953.
国家卫生健康委卫生发展研究中心. 心血管病药品临床综合评价技术指南:2021年版 [EB/OL].(2021-12-31)[2022-07-19]. http://www.nhei.cn/nhei/znfb/202112/9e35-0a54d2ea4c3ab9a0237ee4eab9f0.shtmlhttp://www.nhei.cn/nhei/znfb/202112/9e35-0a54d2ea4c3ab9a0237ee4eab9f0.shtml.
山东省医院协会药物经济学专业委员会. 集中带量采购政策下山东省调脂药物临床综合评价专家共识[J]. 中国药房,2022,33(15):1793-1798.
赵志刚,董占军,刘建平. 中国医疗机构药品评价与遴选快速指南[J]. 医药导报,2020,39(11):1457-1465.
国家卫生健康委员会. 药品临床综合评价管理指南:2021年版试行[EB/OL].(2021-07-28). [2022-07-19]. http://www.nhc.gov.cn/yaozs/s2908/202107/532e20800a-47415d84adf3797b0f4869.shtmlhttp://www.nhc.gov.cn/yaozs/s2908/202107/532e20800a-47415d84adf3797b0f4869.shtml.
刘昭,申丽君,张帆,等. 不同价格场景下二线抗结核药品疗程费用及总费用测算[J]. 中国药物经济学,2019,14(8):13-18,51.
《中国医疗机构药品临床综合评价质量控制体系共识》专家组,胡锦芳,吕燕妮,等. 中国医疗机构药品临床综合评价质量控制体系共识[J].中国药业,2022,31(15):1-9.
赵锐,胡若飞,石秀园,等. 我国药品临床综合评价全面质量管理体系的构建[J]. 中国药房,2022,33(12):1409-1414,1429.
张晶晶,李洪超,朱建国,等. 江苏省药品临床综合评价项目质量控制指南[J]. 中国药学杂志,2022,57(10):862-866.
国家药品监督管理局. 药物警戒快讯:2012年第12期(总第116期)[EB/OL].(2012-12-27)[2022-09-24]. https:// www.nmpa.gov.cn/xxgk/yjjsh/ywjjkx/201212271200018-60.htmlhttps://www.nmpa.gov.cn/xxgk/yjjsh/ywjjkx/201212271200018-60.html.
国家药品监督管理局. 药物警戒快讯:2008年第5期(总第54期)[EB/OL].(2008-06-18)[2022-09-24]. https://www.nmpa.gov.cn/xxgk/yjjsh/ywjjkx/200806181200019-76.htmlhttps://www.nmpa.gov.cn/xxgk/yjjsh/ywjjkx/200806181200019-76.html.
国家药品监督管理局. 药物警戒快讯:2010年第13期(总第90期)[EB/OL].(2010-11-11)[2022-09-24]. https://www.nmpa.gov.cn/xxgk/yjjsh/ywjjkx/201011111200013-28.htmlhttps://www.nmpa.gov.cn/xxgk/yjjsh/ywjjkx/201011111200013-28.html.
GIUGLIANO R P,SABATINE M S. Are PCSK9 inhibitors the next breakthrough in the cardiovascular field?[J]. J Am Coll Cardiol,2015,65(24):2638-2651.
WHO. Measuring medicine prices,availability,affordabi-lity and price components,2nd edition [EB/OL].[2022-09-24]. http://www.haiweb.org/medicineprices/manual/documents.htmlhttp://www.haiweb.org/medicineprices/manual/documents.html.
崔林. 积极履行药品临床综合评价职能 江苏探索构建“大评价+小评价”模式[J]. 中国卫生,2022(2):108-109.
江苏:药品临床综合评价路径需标准化[J]. 中国卫生,2021(6):83.
SCHMALZ U,SPINLER S,RINGBECK J. Lessons learned from a two-round delphi-based scenario study[J]. MethodsX,2021,8:101179.
ZHAO Z G,CHENG J Q,XU S L,et al. A quality assessment index framework for public health services:a Delphi study[J]. Public Health,2015,129(1):43-51.
石磊,母东煜,龚杰,等. 应用德尔菲法初步完善特殊医学用途配方食品综合评价指标体系:以2型糖尿病为例[J]. 中国循证医学杂志,2020,20(9):1012-1019.
陈磊,姚伟召,郭全魁,等. 效能评估理论、方法及应用[M]. 北京:北京邮电大学出版社,2015:13-22.
曹旺,尉耘翠,赵立波,等. 真实世界研究在儿童药品评价及决策应用中的机遇与挑战[J]. 医药导报,2022,41(1):35-38.
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