北京中医药大学东直门医院通州院区;北京中医药大学东直门医院;北京中医药大学;河南中医药大学;
中医药在缓解糖尿病肾病（DKD）症状和延缓病程方面具有独特优势，但传统临床试验中以终末期肾病的发生作为终点指标，需长时间随访，增加了试验的复杂性和成本，限制了中医药临床试验的可行性。认为在中医药治疗DKD的临床试验中，肾小球滤过率（eGFR）变化率（≥30%）和eGFR斜率均可作为潜在的替代结局指标，若干预周期较短（<1年），建议使用eGFR变化率（≥30%）作为替代结局指标；而在长期（≥1年）干预的研究中，eGFR斜率则可能更优。在理化指标如eGFR斜率、尿白蛋白/肌酐比值（UACR）变化率的基础上，结合中医症状学评价、中医证候评价与生活质量量表，开发可被国际认可的中医患者报告结局指标，将是提升中医药治疗DKD疗效评估体系的关键步骤。
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基本信息:
DOI：10.13288/j.11-2166/r.2025.08.006
中图分类号:R259;R277.5
引用信息:
[1]曹灿,孙卫卫,马彤等.中医药治疗糖尿病肾病临床试验替代结局指标的探索与思考[J].中医杂志,2025,66(08):790-794.DOI:10.13288/j.11-2166/r.2025.08.006.
基金信息:
北京中医药大学东直门医院临床研究和成果转化能力提升试点项目（DZMG-TZZX-24010）; 2022年度基本科研业务费揭榜挂帅项目（2022-JYB-JBZR-038）; 国家中医药管理局中医药传承与创新“百千万”人才工程（岐黄学者）（国中医药人教发[2018]12号）