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| 中药治疗糖尿病肾病随机对照试验的结局指标现状分析：基于核心指标集视角 |
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谭可轩1, 生晓迪2, 宁涵1, 龙海伦1, 郭泽慧3, 胡佳慧4, 张欣宇1, 郭利平2
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1.天津中医药大学研究生院, 天津 301617;2.天津市中医药研究院附属医院, 天津 300120;3.天津市中医药研究院, 天津 300120;4.长春中医药大学针灸推拿学院, 长春 130117
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| 摘要: |
| [目的] 系统分析中药治疗糖尿病肾病（DN）随机对照试验（RCT）结局指标的报告现状，明确当前中药治疗DN 的 RCT 中各类结局指标的使用频率、分布特征及存在的主要问题，为核心指标集（COS）的构建提供证据参考。[方法] 检索中国知网、万方知识服务平台、维普数据库、中国生物医学文献服务系统、PubMed、Cochrane Library、Embase 及 ChiCTR、ClinicalTrials.gov 中 2020 年 1 月 1 日—2024 年 12 月 31 日发表或注册的中药治疗 DN RCT，采用Cochrane 偏倚风险评估工具（RoB 1）评价方法学质量，对结局指标进行归类并作描述性统计。[结果] 共纳入 218 项RCT。RoB 1 评估显示，随机序列产生、分配隐藏、结果评价者盲法、受试者盲法、结果数据完整性、选择性报告及其他偏倚维度的低偏倚风险占比分别为 70.64%、1.38%、27.06%、1.38%、93.58%、99.08% 和 0.92%，提示分配隐藏和盲法实施尤为不足。共涉及 88 种结局指标，累计应用 3 160 次，其中理化检测类 3 014 次（95.38%），安全性类 78 次（2.47%），中医症状/证候类 46 次（1.46%），症状体征类和生活质量类各 10 次（0.32%），远期预后类仅 2 次（0.06%）。[结论] 当前中药治疗 DN 的 RCT 结局指标选择与报告缺乏统一规范，未来需构建核心指标集，提升方案预设与报告质量。 |
| 关键词: 糖尿病肾病 结局指标 核心指标集 中医药 随机对照试验 |
| DOI：10.11656/j.issn.1672-1519.2026.10.07 |
| 分类号:R587.2 |
| 基金项目:河北省中医药管理局科研计划项目（T2025052）；天津市中医药研究院附属医院“强力科技人才培养计划”项目（津中研附院人字〔2024〕55号）。 |
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| Current status of outcome indicators in randomized controlled trials of traditional Chinese medicine for diabetic nephropathy：A core outcome set perspective |
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TAN Kexuan1, SHENG Xiaodi2, NING Han1, LONG Hailun1, GUO Zehui3, HU Jiahui4, ZHANG Xinyu1, GUO Liping2
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1.Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine, Tianjin 300120, China;3.Tianjin Academy of Traditional Chinese Medicine, Tianjin 300120, China;4.School of Acupuncture-Moxibustion and Tuina, Changchun University of Chinese Medicine, Changchun 130117, China
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| Abstract: |
| [Objective] To systematically analyze the reporting status of outcome indicators in randomized controlled trials（RCTs）of traditional Chinese medicine（TCM）for diabetic nephropathy（DN），clarify the frequency of use，distribution characteristics and main existing problems of various outcome indicators in current RCTs of TCM for DN，and provide evidence reference for the construction of a core outcome set（COS）. [Methods] RCTs of TCM for DN published or registered from January 1，2020 to December 31，2024 were retrieved from CNKI，Wanfang Database，VIP，SinoMed，PubMed，Cochrane Library，Embase，ChiCTR and ClinicalTrials. gov. The Cochrane Risk of Bias Assessment Tool（RoB 1）was used to evaluate the methodological quality，and the outcome indicators were classified and descriptive statistics were performed. [Results] A total of 218 RCTs were included. RoB 1 assessment showed that the proportions of low bias risk in the dimensions of random sequence generation，allocation concealment，outcome assessor blinding， participant blinding，completeness of outcome data，selective reporting and other biases were 70.64%，1.38%，27.06%，1.38%， 93.58%，99.08% and 0.92%，respectively，indicating that the implementation of allocation concealment and blinding was particularly insufficient. A total of 88 types of outcome indicators were involved，with a cumulative application of 3 160 times，including 3 014 times （95.38%）for physicochemical detection indicators，78 times（2.47%）for safety indicators，46 times（1.46%）for TCM symptom/syndrome indicators，10 times（0.32%）each for symptom and sign indicators and quality of life indicators，and only 2 times（0.06%）for long-term prognosis indicators. [Conclusion] At present，the selection and reporting of outcome indicators in RCTs of TCM for DN lack unified standards. In the future，it is necessary to construct a core outcome set to improve the quality of protocol prespecification and reporting. |
| Key words: diabetic nephropathy outcome indicator core outcome set traditional Chinese medicine randomized controlled trial |
