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恶性肿瘤药物治疗相关不良事件健康状态负效用测量研究的

系统评价 Δ

＊
卢钰琼 ，代展菁，路 云，常 峰（中国药科大学国际医药商学院，南京 211198）
#
中图分类号 R956 文献标志码 A 文章编号 1001-0408（2022）14-1748-06
DOI 10.6039/j.issn.1001-0408.2022.14.15

摘 要 目的 为我国开展健康状态负效用测量研究、计算药物经济学评价中的健康产出提供方法学参考。方法 计算机检索中国
知网、万方数据、维普网3个中文数据库和PubMed、Web of Science、the Cochrane Library 3个英文数据库中有关恶性肿瘤药物治疗
相关不良事件负效用测量的文献，检索时限均为各数据库建库起至2021年7月。由2名研究者独立筛选文献并提取资料后进行
定性分析，采用改良后的英国国家卫生与临床优化研究所决策技术支持文件进行质量评估，总结健康状态负效用测量的实践情况
和存在问题并提出建议。结果 共纳入相关文献77篇。首篇文献发表于1991年，之后发表数量呈波动式上升。77篇文献共涉及
120种不良事件，以效用研究（49篇，63.64％）为主，仅有3篇（3.90％）的调查国家/地区涉及中国。35篇文献（45.45％）未说明研究
设计类型；48篇（62.34％）未说明健康状态开发方法；52篇（67.53％）未说明健康状态验证方法；46篇（59.74％）设定并说明了基础
健康状态；20 篇（25.97％）进行了健康状态排名；应用的效用测量工具主要为标准博弈法和欧洲五维健康量表（各 23 篇，各占
29.87％）；45篇（58.44％）的调研对象为患者人群；63篇（81.82％）未说明人群代表性检验；效用报告类型包括负值、非负值以及合
并基础状态的非负值3种类型；45篇（58.44％）未说明效用统计方法。纳入研究的整体质量评价得分为0.683分。结论 现有负效
用测量包括基础研究设计、健康状态确定、效用测量调研和调研数据统计4个关键环节，相关研究存在中国人群数据缺乏、结果报
告类型不一致、测量重点事项报告不完整等问题。建议今后应进一步规范负效用测量基本实施路径，制订健康状态效用值测量指
南，加强多学科合作，以提高健康状态效用测量的研究质量。
关键词 恶性肿瘤；药物；不良事件；负效用；健康状态效用值；系统评价

Study of health state disutility value estimation of malignant tumor drugs-related adverse events：a
systematic review
LU Yuqiong，DAI Zhanjing，LU Yun，CHANG Feng（School of International Pharmaceutical Business，China
Pharmaceutical University，Nanjing 211198，China）

ABSTRACT OBJECTIVE To provide methodology reference for conducting health state disutility estimation and calculating
health output in pharmacoeconomic evaluation. METHODS Literatures about health state disutility estimation of malignant tumor
drugs-related adverse events were retrieved from 3 Chinese databases such as CNKI，Wanfang database and VIP and 3 English
database such as PubMed，Web of Science and the Cochrane Library from inception to July 2021. After 2 researchers independently
screened the literature and extracted the data，qualitative analysis was conducted. The modified decision-making technical support
documents of the National Institute for Health and Care Excellence were used for quality evaluation. The practice and existing
problems of health state disutility measurement were summarized to put forward some suggestions. RESULTS A total of 77
literatures were included. The first literature was published in 1991，and the number of publications increased in a fluctuating
manner. 77 literatures involved 120 kinds of adverse events，mainly utility studies （49，63.64％），only 3 （3.90％） were
investigated in China. A total of 35 literatures（45.45％）had no statement of study design type，48（62.34％）had no statement of
health status development method，52（67.53％）had no statement of health status verification method，46（59.74％）set and
explained the basic health status，and 20（25.97％）were ranked for the health status. The utility measurement tools used were
mainly the standard game method and the European five-dimensional health scale（23 literatures each，accounting for 29.87％）.
The research objects of 45 literatures（58.44％）were patients，and 63（81.82％）did not specify the representative test of the
population. Utility report types included negative value，non-negative value and non-negative value of consolidated basic status. A
total of 45 literatures（58.44％）had no statement of statistical method of utility. Overall quality score of included studies was
0.683. CONCLUSIONS The current disutility estimation
Δ 基金项目 抗肿瘤药物临床药物政策研究项目（No.校合 2021-
include 4 key links of basic study design， health status
商065）
confirmation， utility estimation survey and survey data
＊第一作者 博士研究生。研究方向：药物经济学、卫生政策。
E-mail：luyuqiong96@foxmail.com statistics. The deficiencies of related studies are the lack of
# 通信作者 教授，博士生导师，博士。研究方向：药物经济学、卫 data based on the Chinese population，the inconsistent type of
生政策。E-mail：cpucf@163.com result reporting，and the incomplete report of measurement-

·1748 · China Pharmacy 2022 Vol. 33 No. 14 中国药房 2022年第33卷第14期