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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
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| 篇名： | 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 |
| TITLE： | Study of health state disutility value estimation of malignant tumor drugs-related adverse events ：a systematic review |
| 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、WebofScience、theCochraneLibrary3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。 |
| ABSTRACT： | OBJECTIVE To provide methodology re ference 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 include 4 key links of basic study design ， health status confirmation， utility estimation survey and survey data E-mail：luyuqiong96@foxmail.com statistics. The deficiencies of related studies are the lack of data based on the Chinese population ，the inconsistent type ofresult reporting ，and the incomplete report of measurement- related critical items. It is recommended to standardize the basic implementation path of disutility estimation ，formulate guidelines for health status utility value estimation ，and strengthen multidisciplinary cooperation so as to improve the quality of health status utility value estimation . |
| 期刊： | 2022年第33卷第14期 |
| 作者： | 卢钰琼，代展菁，路云，常峰 |
| AUTHORS： | LU Yuqiong ，DAI Zhanjing ，LU Yun，CHANG Feng |
| 关键字： | 恶性肿瘤；药物；不良事件；负效用；健康状态效用值；系统评价 |
| KEYWORDS： | malignant tumor ；drugs；adverse events ；disutility；health state utility value ；systematic review |
| 阅读数： | 231 次 |
| 本月下载数： | 9 次 |
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