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·医药热点·

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 Δ

山东省医院协会药物经济学专业委员会

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中图分类号 R972 .6 文献标志码 A 文章编号 1001-0408（2022）15-1793-06
DOI 10.6039/j.issn.1001-0408.2022.15.01

摘 要 药物临床综合评价是促进药品回归临床价值的重要技术工具。在集中带量采购常态化制度化开展的背景下，积极组织
开展药物临床综合评价工作至关重要。截至2022年3月，已纳入国家和山东省集中带量采购的调脂药物共有5个。为积极推动
医疗机构规范开展调脂药物的临床综合评价，由山东第一医科大学附属省立医院牵头，以山东省医院协会为依托，山东省19家三
级甲等医院共同参与，运用德尔菲法，通过 3 轮专家意见调查及广泛讨论，制定了《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》。该共识采用百分制量化评估，从药学特性、有效性、安全性、经济性、适宜性、可及性、创新性、其他属性共8个维
度，对山东省集中带量采购涉及的15个调脂药物进行了临床综合评价，并根据分值形成不同的推荐级别。本共识的制定将有助
于医疗机构在集中带量采购背景下合理配备和使用调脂药物，从而更好地满足国家政策需求，不断提高药事服务质量。
关键词 集中带量采购；山东省；调脂药物；临床综合评价；专家共识

Expert consensus on the comprehensive clinical evaluation of lipid-lowering drugs under the centralized
drug volume-based procurement policy in Shandong Province
Pharmacoeconomics Committee of Shandong Hospital Association

ABSTRACT Comprehensive clinical evaluation of drugs is an important technical tool to promote the return of drugs to clinical
value. Under the background of normalization and institutionalization of centralized drug volume-based procurement，it is very
crucial to actively organize and carry out comprehensive clinical evaluation of drugs. As of March 2022，there are 5 lipid-lowing
drugs that have been included in the centralized drug volume-based procurement of the state and Shandong Province. In order to
actively promote the medical institutions to develop the comprehensive clinical evaluation of lipid-lowing drugs standardly，led by
the Shandong Provincial Hospital Affiliated to Shandong First Medical University，supported by Shandong Hospital Association，and
19 third grade class A hospitals in Shandong Province jointly participated，Using Delphi method，through three rounds of expert
opinion investigation and extensive discussion，Expert Consensus on the Comprehensive Clinical Evaluation of Lipid-lowering
Drugs under the Centralized Drug Volume-based Procurement Policy in Shandong Province was developed. The expert consensus
adopted the percentage system for quantitative evaluation. The comprehensive clinical evaluation on 15 lipid-lowing drugs involved
in centralized drug volume-based procurement in Shandong Province was implemented from eight dimensions including
pharmaceutical characteristics，effectiveness，safety，economy，suitability，accessibility，innovation and other attributes，and different
recommendation levels were formed according to the scores. The development of this consensus will help medical institutions to
reasonably allocate and use lipid-lowering drugs in the context of centralized drug volume-based procurement，so as to better satisfy
the national policy needs and continuously improve the quality of pharmaceutical services.
KEYWORDS centralized drug volume-based procurement；Shandong Province；lipid-lowering drugs；comprehensive clinical
evaluation；expert consensus

2021 年 1 月 22 日，国务院办公厅发布《关于推动药 决执行国家药品集中带量采购政策的同时，也积极开展
品集中带量采购工作常态化制度化开展的意见》，明确 省内药品的集中带量采购工作。为进一步贯彻落实党
推动药品集中带量采购工作常态化、制度化开展，促进 中央、国务院关于健全药品供应保障制度的决策部署，
医药行业健康发展，推动公立医疗机构改革，更好地保 促进药品回归临床价值，2021 年 7 月 21 日，国家卫生健
[1]
障人民群众病有所医 。截至 2022 年 3 月，我国已组织 康委办公厅发布《关于规范开展药品临床综合评价工作
开展5批药品集中带量采购，其采购重点主要为基本医 的通知》，鼓励医疗卫生机构自主或牵头搭建工作团队，
保目录内用量较大、采购金额较高的药品。山东省在坚 组织开展药品临床综合评价工作 。
[2]
Δ 基金项目 国家自然科学基金面上项目（No.82070819） 血脂异常是临床常见的慢性病，是动脉粥样硬化性

中国药房 2022年第33卷第15期 China Pharmacy 2022 Vol. 33 No. 15 ·1793 ·