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临床前研究包括动物实验及体外实验的药理、毒理、药代动力学等研究，是药品和医疗产品上市前的关键环节，对于探索中医药疗效机制、促进临床转化至关重要。中医药领域临床前研究系统评价和Meta分析可全面综合临床前研究证据、整合研究结果、评估纳入研究的质量与偏倚风险、提升研究利用度、减少资源浪费，促进中医药研究模型与评价指标的优化迭代。从定义研究问题、组建研究团队、撰写注册研究方案、系统全面检索、文献筛选、纳入研究的评价、数据提取、数据综合（Meta分析）和中医药临床前研究系统评价报告9个步骤，介绍中医药领域临床前研究系统评价和Meta分析的制作流程与方法，以期为开展中医药临床前研究系统评价和Meta分析提供方法学参考，促进中医药领域证据体系的建立与完善。
Abstract：Preclinical studies include pharmacology, toxicology, pharmacokinetics research of animal experiments and in vitro experiments, which are crucial steps in the pre-marketing drugs and medical products, and are essential for exploring the mechanisms of traditional Chinese Medicine(TCM) therapeutic mechanism and promoting clinical translation. Systematic reviews and meta-analyses of preclinical studies in the field of TCM can comprehensively integrate preclinical evidence, consolidate research findings, assess the quality and risk of bias of included studies, enhance the utilization of research results, reduce resource waste, and promote the iterative optimization of TCM research models and evaluation indicators. This article introduced the process and methodology of conducting systematic review and meta-analyses of preclinical studies in TCM from nine steps, defining the research question, forming a research team, writing and registering a study protocol, conducting a comprehensive search, screening literature, evaluating included studies, extracting data, synthesizing data(meta-analysis), and reporting systematic reviews. It aims to provide methodological references for conducting systematic reviews and meta-analyses of preclinical studies in TCM and to promote the establishment and improvement of the evidence system in the field of TCM.
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基本信息:
DOI：10.13288/j.11-2166/r.2025.13.006
中图分类号:R2-03
引用信息:
[1]王文雅,景城阳,施兰君等.中医药领域临床前研究系统评价和Meta分析的应用与制作要点[J].中医杂志,2025,66(13):1333-1339.DOI:10.13288/j.11-2166/r.2025.13.006.
基金信息:
中国中医科学院科技创新工程项目（CI2021A05503,CI2021A00701-3）; 中国中医药循证医学中心“业务研究室主任专项”（2020YJSZX-2）