Page 39 - 《中国药房》2023年11期

抗肺癌药品临床综合评价指标体系的构建及实证研究

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林思思 ，陈丽萍 ，江绮云 ，宣建伟 ，张 群 （1.南方医科大学第三附属医院药物临床试验机构办公室，
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广州 510630；2.中山大学药学院医药经济研究所，广州 510006）
中图分类号 R979.1 文献标志码 A 文章编号 1001-0408（2023）11-1313-07
DOI 10.6039/j.issn.1001-0408.2023.11.06

摘 要 目的 构建抗肺癌药品临床综合评价指标体系，为药品遴选和临床合理用药提供依据。方法 遵循《药品临床综合评价管
理指南（2021年版试行）》相关规定，通过文献分析法初步拟定评价指标体系框架及指标预选池，基于德尔菲法对评价指标进行筛
选和修改，运用专家直接打分法及相关计算得到各个指标的权重，从而制定抗肺癌药品临床综合评价指标体系；参考《中国医疗机
构药品评价与遴选快速指南》制定抗肺癌药品临床综合评价指标评分细则。使用所建临床综合评价指标体系和评分细则对抗肺
癌药品帕博利珠单抗开展实证评价。结果 所构建的抗肺癌药品临床综合评价指标体系包括6个一级指标、15个二级指标，其中
一级指标的权重分别为安全性18、有效性38、经济性15、创新性9、适宜性10、可及性10。初步构建了抗肺癌药品临床综合评价指
标评分细则。实证评价结果显示，帕博利珠单抗联合化疗方案的综合评分（61分）高于单纯化疗方案（56分），前者的有效性、创新
性、适宜性均优于后者，而后者的安全性、经济性均优于前者。结论 所构建的抗肺癌药品临床综合评价指标体系具有可推广落地
性，可为临床合理用药提供参考依据。
关键词 药品临床综合评价；肺癌；抗肿瘤药物；指标体系；指标评分细则

Construction of clinical comprehensive evaluation index system of anti-lung cancer drugs and empirical
study
LIN Sisi ，CHEN Liping ，JIANG Qiyun ，XUAN Jianwei ，ZHANG Qun （1. Office of Drug Clinical Trial
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Institution， the Third Affiliated Hospital of Southern Medical University， Guangzhou 510630， China；2. Health
Economics Research Institute， School of Pharmaceutical Sciences， Sun Yat-Sen University， Guangzhou 510006，
China）
ABSTRACT OBJECTIVE To construct a comprehensive evaluation index system for anti-lung cancer drugs， and to provide a
basis for drug selection and rational clinical use. METHODS Based on the Guidelines for the Management of Comprehensive
Clinical Evaluation of Drugs （2021 edition for trial use）， a preliminary evaluation index system framework and an index
preselection pool were initially formulated through literature analysis. The evaluation indices were then selected and modified by
using the Delphi method. The weights of each index were determined through expert scoring and relevant calculations， thereby
establishing a comprehensive evaluation index system for anti-lung cancer drugs. Referred to Quick Guideline for Drug Evaluation
and Selection in Chinese Medical Institutions， scoring detailed rules for clinical comprehensive evaluation indexes of anti-lung
cancer drugs were formulated. The constructed comprehensive evaluation index system and scoring detailed rules were applied to
conduct empirical evaluation of the anti-lung cancer drug pembrolizumab. RESULTS The constructed comprehensive evaluation
index system for anti-lung cancer drugs included 6 primary indicators and 15 secondary indicators. The weights of the primary
indicators were as follows： safety （18）， efficacy （38）， economy （15）， innovation （9）， suitability （10）， and accessibility （10）.
The scoring detailed rules for the comprehensive evaluation index system for anti-lung cancer drugs had been preliminarily
established. The results of empirical evaluation showed that the comprehensive evaluation score （61 points） of pembrolizumab
combined with chemotherapy regimen was higher than that of the monotherapy chemotherapy regimen （56 points）. The former
demonstrated superior efficacy， innovation and suitability compared to the latter， while the latter exhibited better safety and
economy. CONCLUSIONS The constructed comprehensive evaluation index system for anti-lung cancer drugs has the potential for
generalizability and practical application， providing a reference
＊第一作者 硕士研究生。研究方向：药物经济学。E-mail：
basis for rational clinical drug use.
lss916cc@i.smu.edu.cn KEYWORDS clinical comprehensive evaluation of drugs；
#a 通信作者 教授，硕士生导师，博士。研究方向：卫生政策、卫生
经济学。E-mail：jwx02467@jmail.com lung cancer； antineoplastic drugs； index system； indicator
#b 通信作者 副主任药师，硕士生导师，博士。研究方向：中药学、 scoring detailed rules
药学、医学教育与医学边缘学科。E-mail：zq1979@smu.edu.cn

中国药房 2023年第34卷第11期 China Pharmacy 2023 Vol. 34 No. 11 · 1313 ·