Page 13 - 《中国药房》2022年11期

国内外抗肿瘤药物临床价值评估体系比较 Δ

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郎驿天 ，柴青青 ，廖雅慧 ，刘晓琰 ，胡元佳 （1.上海交通大学医学院附属第九人民医院黄浦分院药剂科，
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上海 200011；2. 澳门大学中华医药研究院中药质量研究国家重点实验室，澳门 999078）
中图分类号 R979.1 文献标志码 A 文章编号 1001-0408（2022）11-1287-08
DOI 10.6039/j.issn.1001-0408.2022.11.02

摘 要 目的 介绍国内外主要的抗肿瘤药物临床价值评估体系，为我国以临床价值为导向的抗肿瘤药物研发指导原则的不断完
善提供参考。方法 查阅国外抗肿瘤药物价值评估体系的相关资料和国内抗肿瘤药物研发和管理政策，对其维度、视角、目标受
众、应用范围、优缺点等进行梳理与对比分析，提出完善我国抗肿瘤药物临床价值评估体系的建议。结果与结论 7个国外价值评
估体系（美国临床肿瘤学会价值框架、欧洲临床肿瘤学学会临床效益量表、美国临床和经济评估研究所价值评估框架等）各有特
点，在不同的设定下有其独特的优势；几种价值评估体系因侧重的研究视角和受众群体不同，评判价值的标准存在一定程度的差
异。而价值维度在不断地顺应科学价值和社会需求动态变化，不仅包括安全性、有效性和经济性，还包括创新性、公平性、生命质
量等多个高价值属性；部分评估体系在展现形式以及评估模式上采用了比较方便且顺应信息时代趋势的价值评估工具，促进了医
患共享决策。我国可以综合国外价值评估体系的特点并结合我国抗肿瘤药物研发和应用现状，对药品的有效性、安全性、生命质
量、研发成本以及定价进行综合考虑，使其定位合理，真正从药品研发、临床应用以及药品可及性和公平性等角度解决患者需求。
关键词 抗肿瘤药物；临床价值；价值评估体系

Comparison of evaluation system for clinical value of antineoplastic agents at home and abroad
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LANG Yitian ，CHAI Qingqing ，LIAO Yahui ，LIU Xiaoyan ，HU Yuanjia（1. Dept. of Pharmacy，Huangpu
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Branch，Shanghai Ninth People’s Hospital，Shanghai Jiaotong University School of Medicine，Shanghai
200011，China；2. State Key Laboratory of Quality Research in Chinese Medicine，University of Macau，
Macau 999078，China）
ABSTRACT OBJECTIVE To introduce the evaluation system for clinical value of antineoplastic agents at home and abroad，and
to provide reference for continuous improvement of clinical value-oriented antineoplastic agents development and research guideline
in China. METHODS The suggestions were put forward to improve the evaluation system for clinical value of antineoplastic agents
in China by consulting the relevant data of evaluation system for clinical value of antineoplastic agents at home and abroad and
domestic antineoplastic agents R&D and management policies， sort outing and analyzing comparatively their dimensions，
perspectives，target audiences，application scope，advantages and disadvantages. RESULTS & CONCLUSIONS Seven foreign
value evaluation systems （value assessment framework of American Society of Clinical Oncology，clinical benefit scale of
European Society of Clinical Oncology，value evaluation framework of American Institute of Clinical and Economic Evaluation，
etc.）had their own characteristics and unique advantages under different settings；several value evaluation systems differed in the
criteria for defining value，depending on the perspective and population they focus on. The value dimensions were constantly
changing dynamically in response to scientific values and social needs，including not only safety，efficacy and cost-effectiveness，
but also innovation，fairness，quality of life attributes. Some evaluation systems adopted value assessment tools that followed the
trend of the information age in the presentation form and assessment mode，which promoted shared decision-making between
doctors and patients. Combining the characteristics of foreign value evaluation system and the current situation of development and
application of antineoplastic agents in China，we can have a deeper understanding of drug efficacy，safety，quality of life，research
and development cost and pricing in the future. Antineoplastic
Δ 基金项目：吴阶平医学基金会临床科研专项（No.320.6750.
2021-10-28） agents will have a more reasonable position to solve the unmet
＊药师，硕士。研究方向：循证药学、药物经济学、医药政策。电 needs of patients from the perspectives of drug research and
话：021-23308787。E-mail：etonla@163.com development， clinical application， drug accessibility and
#a 通信作者：主任药师，博士。研究方向：临床药学。E-mail：
fairness.
liuxiaoyanrj@sjtu.edu.cn
KEYWORDS antineoplastic agents； clinical value； value
#b通信作者：副教授，博士。研究方向：医药市场分析、医药知识
evaluation system
与创新管理。E-mail：yuanjiahu@um.edu.mo

中国药房 2022年第33卷第11期 China Pharmacy 2022 Vol. 33 No. 11 ·1287 ·