中国中西医结合杂志2025，Vol.45Issue(9)：1029-1033,5.DOI:10.7661/j.cjim.20250515.254
中医药临床试验亚组分析设计和报告建议
Subgroup Analysis in Chinese Medicine Clinical Trials:Design and Reporting Recommendations
摘要
Abstract
Chinese Medicine(CM),with its emphasis on syndrome differentiation and individualized treatment,highlights the need to tailor therapeutic strategies to patients with distinct syndromes and constitutions.Subgroup analysis in clinical research plays a critical role in exploring the interactions between treatment efficacy and various influencing factors.Subgroup analysis in CM clinical trials is conducive to exploring the differences in therapeutic effects among patients with different characteristics,thereby providing clinical evidence for precise treatment.Authors introduced the concept and role of subgroup analysis,and provided recommendations for conducting high-quality subgroup analysis in CM clinical trials from the perspectives of its design,analysis,reporting,and interpretation.Despite its potential,subgroup analysis remains underutilized and insufficiently standardized in the CM field.There is a pressing need for the establishment of comprehensive guidelines or standards to enhance the quality and reliability of CM clinical trial design and data analysis.关键词
中医药/亚组分析/临床试验/研究设计/报告Key words
Chinese medicine/subgroup analysis/clinical trial/study design/report引用本文复制引用
李宇飞,张文倩,张颖,刘建平..中医药临床试验亚组分析设计和报告建议[J].中国中西医结合杂志,2025,45(9):1029-1033,5.基金项目
北京中医药大学横向科研项目(No.2023-HXFZJJ-025) （No.2023-HXFZJJ-025）
