提高动物实验系统评价/Meta分析的证据确定性：GRADE方法的实证研究

doi:10.12300/j.issn.1674-5817.2024.109

实验动物与比较医学 ›› 2025, Vol. 45 ›› Issue (1): 101-111.DOI: 10.12300/j.issn.1674-5817.2024.109

• 比较医学研究与报告规范 • 上一篇下一篇

提高动物实验系统评价/Meta分析的证据确定性：GRADE方法的实证研究

李腾飞¹^,²^,³()(), 郑卿勇¹^,²()(), 许建国¹^,², 李艺羿¹^,²^,³, 周泳佳¹^,²^,³, 徐彩花¹^,², 张明悦¹^,², 田杰祥⁴, 王钢⁴(), 田金徽¹^,²()()

^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.甘肃中医药大学护理学院, 兰州 730000
^4.甘肃中医药大学附属医院风湿免疫科, 兰州 730000

收稿日期:2024-07-26 修回日期:2024-12-03 出版日期:2025-03-12 发布日期:2025-02-25
通讯作者: 王钢（1965—），男，博士，主任医师，博士生导师，研究方向：中西医结合治疗自身免疫性疾病的临床与实验研究。E-mail： 1256935844@qq.com；<br/>
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-
作者简介:李腾飞（1998—），男，硕士研究生，研究方向：循证医学与医学信息学。E-mail： ltf980102@163.com。ORCID： 0009-0005-1168-3075；
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
基金资助:
2023年中央财政转移支付地方项目“中医药循证能力提升建设”(2101704)

Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method

LI Tengfei¹^,²^,³()(), ZHENG Qingyong¹^,²()(), XU Jianguo¹^,², LI Yiyi¹^,²^,³, ZHOU Yongjia¹^,²^,³, XU Caihua¹^,², ZHANG Mingyue¹^,², TIAN Jiexiang⁴, WANG Gang⁴(), TIAN Jinhui¹^,²()()

^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.School of Nursing, Gansu University of Chinese Medicine, Lanzhou 730000, China
^4.Department of Rheumatology, The Affiliated Hospital of Gansu University of Chinese Medicine, Lanzhou 730000, China

Received:2024-07-26 Revised:2024-12-03 Published:2025-02-25 Online:2025-03-12
Contact: WANG Gang, E-mail: 1256935844@qq.com;
TIAN Jinhui (ORCID: 0000-0002-3859-9587), E-mail: tjh996@163.com

摘要/Abstract

摘要：

动物实验是生物医学研究中的重要手段，是连接基础研究与临床试验的桥梁。动物实验的系统评价/Meta分析（systematic review/meta-analysis，SRs/MAs）是整合动物实验证据的重要手段，能够促进成果向临床研究转化，降低转化风险，并推动基础研究的资源整合。随着证据推荐分级的评估、制订与评价（grading of recommendations assessment，development and evaluation，GRADE）方法的不断发展，其在动物实验SRs/MAs中的应用受到了越来越多的关注。本文首先阐述了GRADE方法在动物实验SRs/MAs中的应用原理及具体应用类型，包括定性描述的系统评价、Meta分析及网状Meta分析；接着深入分析了GRADE方法在实际应用中的误用情况，主要包括未正确进行证据体分级、证据体分级不当、误用于定性系统评价、升降级过程记录与结果不一致，以及误用于提供推荐意见；此外，还全面探讨了GRADE方法在动物实验SRs/MAs中的证据确信度升降级因素，包括偏倚风险、间接性、不一致性、不精确性和发表偏倚对证据降级的影响，以及大效应量和跨物种一致性对证据升级的作用；最后，针对上述问题提出了改进策略，包括进一步研究与优化GRADE方法在动物实验SRs/MAs中的应用细节、制定符合动物实验研究特点的SRs/MAs报告规范，以及加强研究人员在GRADE方法上的专业培训等。本文旨在通过提升动物实验SRs/MAs的证据质量，增强其在临床决策中的可靠性，促进动物实验研究成果更高效地转化为临床实践。

关键词: 动物实验, 系统评价, Meta分析, 推荐分级的评估、制订与评价, 证据确信度, 证据分级

Abstract:

Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.

Key words: Animal experiment, Systematic reviews, Meta-analyses, Grading of recommendations assessment, development and evaluation, Certainty of evidence, Evidence grading

中图分类号:

Q95-33

李腾飞,郑卿勇,许建国,等. 提高动物实验系统评价/Meta分析的证据确定性：GRADE方法的实证研究[J]. 实验动物与比较医学, 2025, 45(1): 101-111. DOI: 10.12300/j.issn.1674-5817.2024.109.

LI Tengfei,ZHENG Qingyong,XU Jianguo,et al. Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method[J]. Laboratory Animal and Comparative Medicine, 2025, 45(1): 101-111. DOI: 10.12300/j.issn.1674-5817.2024.109.

图/表 3

图1 使用GRADE方法进行证据体确信度分级

Figure 1 Using the GRADE methodology to grade the certainty of evidence

图2 不同数据分析方法的GRADE分级注：CERQual，定性系统评价证据可信度；GRADE，推荐分级的评估、制订与评价。

Figure 2 GRADE for different data analysis methodsNote：CERQual， confidence in the evidence from reviews of qualitative research； GRADE， grading of recommendations assessment， development and evaluation.

图3 研究对象间接性的特殊情况考虑

Figure 3 Special considerations for indirectness in the study population

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提高动物实验系统评价/Meta分析的证据确定性：GRADE方法的实证研究

Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method

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