实验动物与比较医学 ›› 2025, Vol. 45 ›› Issue (4): 496-507.DOI: 10.12300/j.issn.1674-5817.2025.017

• 比较医学研究与报告规范 • 上一篇    下一篇

动物实验系统评价与Meta分析报告的规范撰写建议

郑卿勇1,2,3(), 杨冬华1,2,3,4(), 马智超5, 周姿余5, 陆洋6, 王晶宇1,7, 邢丽娜1,2,3, 康迎英1,2,3, 杜莉8, 赵春香9, 狄宝山10,11, 田金徽1,2,3()()   

  1. 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.中国医学科学院循证评价与指南研究创新单元, 兰州大学基础医学院, 兰州 730000
    4.青海大学附属医院公共卫生和医院感染管理部, 西宁 810001
    5.兰州大学第二临床医学院, 兰州 730000
    6.江苏省中西医结合医院骨伤科, 南京 210028
    7.病理生理学教研室, 兰州大学基础医学院, 兰州 730000
    8.兰州市第三人民医院, 兰州 730050
    9.兰州市第一人民医院, 兰州 730050
    10.甘肃中医药大学第一临床医学院, 兰州 730000
    11.深圳市龙岗中心医院急诊科, 深圳 518116
  • 收稿日期:2025-02-05 修回日期:2025-04-22 出版日期:2025-08-25 发布日期:2025-09-01
  • 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;
    杨冬华(1989—),女,博士研究生,研究方向:循证医学与传染病防控。E-mail:354052891@qq.com。ORCID:0009-0004-7719-6643
  • 基金资助:
    甘肃省科技重大专项计划“甘肃中药材种植技术研究及新药新产品开发与应用”(24ZD17FA003)-子课题“基于大模型和证据生态系统的药食同源决策平台构建与转化”

Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments

ZHENG Qingyong1,2,3(), YANG Donghua1,2,3,4(), MA Zhichao5, ZHOU Ziyu5, LU Yang6, WANG Jingyu1,7, XING Lina1,2,3, KANG Yingying1,2,3, DU Li8, ZHAO Chunxiang9, DI Baoshan10,11, TIAN Jinhui1,2,3()()   

  1. 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 730000, China
    3.Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
    4.Department of Public Health and Healthcare-associated Infection Management, Qinghai University Affiliated Hospital, Xining 810001, China
    5.The Second Clinical Medical College of Lanzhou University, Lanzhou 730000, China
    6.Department of Orthopedics and Traumatology, Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine, Nanjing 210028, China
    7.Department of Pathophysiology, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
    8.The Third People's Hospital of Lanzhou, Lanzhou 730050, China
    9.The First People's Hospital of Lanzhou City, Lanzhou 730050, China
    10.First School of Clinical Medical, Gansu University of Chinese Medicine, Lanzhou 730000, China
    11.Department of Emergency, Shenzhen Longgang Central Hospital, Shenzhen 518116, China
  • Received:2025-02-05 Revised:2025-04-22 Published:2025-08-25 Online:2025-09-01
  • Contact: TIAN Jinhui (ORCID: 0000-0002-3859-9587), E-mail: tjh996@163.com

摘要:

动物实验是生命科学与医学研究的重要环节,但单一动物实验研究因样本量小、设计异质性高、重复性差等固有局限,其结果的外推性与可靠性常受到质疑,从而影响了研究成果向临床的有效转化。系统评价(systematic reviews,SR)和Meta分析(meta-analysis)是整合现有研究证据、提升结论稳健性的关键方法。然而,目前应用于动物实验领域的SR和Meta分析在实施过程与报告撰写上尚缺乏统一规范,导致其研究质量参差不齐,在一定程度上削弱了其证据价值。为解决此问题,本文系统梳理了动物实验SR与Meta分析的报告撰写流程,并提出一套兼顾科学性与实用性的规范化建议。文章内容覆盖了从研究前期准备[包括构建PICO(population, intervention, comparison and outcome)问题、评估可行性与方案预注册]到报告主体各部分的撰写要点。在核心的方法学章节,本文详细论述了如何基于PRISMA(Preferred Reporting Items for Systematic Reviews and Meta-analysis)声明,并结合ARRIVE指南(Animal Research: Reporting of in Vivo Experiments)、SYRCLE(Systematic Review Centre for Laboratory Animal Experimentation)动物实验风险评估工具等相关指南与工具,具体实施文献检索、纳入和排除标准制定、数据提取与偏倚风险评估等环节。对于结果呈现,文章提出了借助流程图与特征表进行清晰、透明化展示的策略。在讨论部分,本文重点探讨了如何科学解读合并效应、深入分析异质性来源和评估发表偏倚影响,并审慎论述动物实验结果向临床外推的有效性与局限性。此外,本文还建议引入GRADE(Grading of Recommendations Assessment, Development and Evaluation)方法对最终的证据质量进行综合分级。本文对报告撰写全流程进行了模块化解析,期望为相关领域研究者提供一份清晰、可行的实践指南,以促进动物实验SR和Meta分析的规范化发展,提升其在科研决策与转化医学中的应用价值。

关键词: 动物实验, 系统评价, Meta分析, 循证医学, 撰写规范

Abstract:

Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.

Key words: Animal experiment, Systematic review, Meta-analysis, Evidence-based medicine, Reporting standards

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