动物实验评价指标体系标准化问题与核心指标集构建策略思考

doi:10.12300/j.issn.1674-5817.2025.056

实验动物与比较医学 ›› 2026, Vol. 46 ›› Issue (1): 138-148.DOI: 10.12300/j.issn.1674-5817.2025.056

• 比较医学研究与报告规范 • 上一篇

动物实验评价指标体系标准化问题与核心指标集构建策略思考

郑卿勇¹^,²(), 周泳佳¹^,²(), 李腾飞³, 许建国¹^,², 田晨²^,⁴^,⁵^,⁶, 刘辉¹^,², 田敏¹^,²^,⁷, 周姿余⁸, 徐彩花¹^,², 崔雅婷¹^,², 王俊斐¹^,², 田金徽¹^,²^,⁹()()

^1.兰州大学循证医学中心, 兰州大学基础医学院, 兰州 730000
^2.甘肃省循证医学重点实验室, 兰州 730000
^3.中国医学科学院北京协和医学院护理学院, 北京 100730
^4.兰州大学公共卫生学院卫生政策与管理学系, 兰州 730000
^5.兰州大学循证社会科学交叉创新实验室, 兰州 730000
^6.兰州大学卫生管理与健康发展研究中心, 兰州 730000
^7.甘肃省人民医院药剂科, 兰州 730000
^8.兰州大学第二临床医学院, 兰州 730030
^9.中国医学科学院循证评价与指南研究创新单元, 兰州 730000

收稿日期:2025-04-23 修回日期:2025-08-20 出版日期:2026-02-25 发布日期:2026-02-14
通讯作者: 田金徽（1978—），男，博士，教授，研究方向：网状Meta分析与卫生技术评估。E-mail： tjh996@163.com。ORCID： 0000-0002-3859-9587
作者简介:郑卿勇（1998—），男，博士研究生，研究方向：循证医学与医学信息学。E-mail： easonzz@foxmail.com。ORCID： 0000-0002-9480-0169；
周泳佳（2000—），女，博士研究生，研究方向：循证医学与医学信息学。E-mail： zhouyongjia0416@163.com。ORCID： 0009-0000-6225-7176
田金徽，教授，博士生导师。兰州大学基础医学院副院长、甘肃省循证医学重点实验室副主任，兼任中国康复医学会循证康复医学工作委员会第二届委员会副主任委员、全国医学文献检索教研会第九届理事会常务理事等。主要从事循证医学方法学研究、医学文献与数据挖掘、循证医学证据转化与利用等工作，并将网状Meta分析方法首次引入到中医药、动物实验和诊断试验中。相关研究成果被评为甘肃省科学技术进步奖一等奖1项、二等奖2项、三等奖1项，以及中国药学会科学技术一等奖、中华中医药学会科学技术奖一等奖等，个人获第九届甘肃省青年科技奖。以第一作者或通信作者发表SCI论文50余篇，入选2023年和2024年全球前2%顶尖科学家榜单。主编、副主编和参编教材及著作22部，获首届全国教材建设奖全国优秀教材二等奖1项、国家教学成果二等奖1项，甘肃省教学成果一等奖1项，甘肃省高校青年教师成才奖，以及兰州大学隆基教学新秀奖、骨干奖和创新奖等。（1978—），男，博士，教授，研究方向：网状Meta分析与卫生技术评估。E-mail： tjh996@163.com。ORCID： 0000-0002-3859-9587
TIAN Jinhui (ORCID: 0000-0002-3859-9587), E-mail: tjh996@163.com
基金资助:
甘肃海智计划项目“‘丝路慧医·智享甘肃’：循证健康科普国际人才与技术交流平台”(KPZX-011030)

Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies

ZHENG Qingyong¹^,²(), ZHOU Yongjia¹^,²(), LI Tengfei³, XU Jianguo¹^,², TIAN Chen²^,⁴^,⁵^,⁶, LIU Hui¹^,², TIAN Min¹^,²^,⁷, ZHOU Ziyu⁸, XU Caihua¹^,², CUI Yating¹^,², WANG Junfei¹^,², TIAN Jinhui¹^,²^,⁹()()

^1.Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
^2.Key Laboratory of Evidence-Based Medicine of Gansu Province, Lanzhou University, Lanzhou 730000, China
^3.School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
^4.Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou 730000, China
^5.Laboratory of Cross-Innovation for Evidence-based Social Sciences, Lanzhou University, Lanzhou 730000, China
^6.Research Centre for Health Management and Health Development, Lanzhou University, Lanzhou 730000, China
^7.Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730000, China
^8.The Second Clinical Medical School, Lanzhou University, Lanzhou 730030, China
^9.Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, Lanzhou 730000, China

Received:2025-04-23 Revised:2025-08-20 Published:2026-02-25 Online:2026-02-14

摘要/Abstract

摘要：

动物实验作为连接基础研究与临床应用的关键环节，其研究质量与转化效率至关重要。近年来，尽管动物实验在操作规程与伦理规范上已取得长足的进步，但其结局评价指标体系的标准化制定却相对滞后，具体表现为同类研究间评价指标选择的高度异质性、实验方法学报告的不完整和结果解读标准的差异，这已成为制约生物医学研究质量与证据整合的关键瓶颈，严重削弱了研究结果的可比性与证据综合。为解决此问题，本文系统性地引入临床研究领域的成熟方法学工具——核心指标集（core outcome set，COS），深入探讨了COS在动物实验领域的构建策略与应用潜力。鉴于动物实验的高度多样性，COS的构建应采取“聚焦关键领域、分步试点、逐步推广”的策略，优先为研究体量大、转化需求迫切且拥有公认模型的特定疾病领域研制专属的COS。本文详细阐述了一套包含“系统文献检索、方法学审评、专家共识”的多源整合构建路径，并探讨了借助AI技术提升构建效率的可行性。构建与推广针对特定动物实验领域的COS，并非旨在限制科学探索，而是倡导形成“核心指标+推荐指标+探索性指标”的分层级评价新范式，这不仅能通过规范化手段提升研究质量、践行“3R”原则，更能加速高质量证据的累积，为高级别证据体系提供坚实基础，从而促进基础研究成果向临床实践的高效转化，为相关学科的科学发展提供关键的方法学支撑。

关键词: 动物实验, 核心结局指标集, 标准化, 证据整合, 研究方法学

Abstract:

Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.

Key words: Animal experimentation, Core outcome set, Standardization, Evidence integration, Research methodology

中图分类号:

Q95-33

郑卿勇,周泳佳,李腾飞,等. 动物实验评价指标体系标准化问题与核心指标集构建策略思考[J]. 实验动物与比较医学, 2026, 46(1): 138-148. DOI: 10.12300/j.issn.1674-5817.2025.056.

ZHENG Qingyong,ZHOU Yongjia,LI Tengfei,et al. Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies[J]. Laboratory Animal and Comparative Medicine, 2026, 46(1): 138-148. DOI: 10.12300/j.issn.1674-5817.2025.056.

图/表 1

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动物实验评价指标体系标准化问题与核心指标集构建策略思考

Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies

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