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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。
Abstract:Traditional Chinese medicine(TCM) has unique advantages in alleviating the symptoms of diabetic kidney disease(DKD) and slowing its progression. However, traditional clinical trials often use the occurrence of end-stage renal disease as the end point, requiring long-term follow-up, which increases trial complexity and costs, thereby limiting the feasibility of TCM clinical studies. This paper suggested that in clinical trials of TCM for DKD, both the estimated glomerular filtration rate(eGFR) change rate (≥30%) and eGFR slope can serve as potential surrogate outcome measures. If the intervention course is short(<1 year), the eGFR change rate (≥30%) is recommended as a surrogate outcome measure, whereas in long-term interventional studies (≥1 year), the eGFR slope may be more appropriate. Furthermore, based on biochemical indicators such as eGFR slope and urinary albumin-tocreatinine ratio(UACR) change rate, integrating TCM symptom evaluation, TCM syndrome evaluation, and quality of life scales can help develop internationally recognized patient-reported outcome measures(PROMs) for TCM clinical trials, which will be a key step in enhancing the evaluation system for the effectiveness of TCM in treating DKD.
[1]THOMAS MC, COOPER ME, ZIMMET P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease[J]. Nat Rev Nephrol, 2016, 12(2):73-81.
[2]FU H, LIU S, BASTACKY SI, et al. Diabetic kidney diseases revisited:a new perspective for a new era[J]. Mol Metab, 2019, 30(12):250-263.
[3]LI H, LU W, WANG A, et al. Changing epidemiology of chronic kidney disease as a result of type 2 diabetes mellitus from 1990 to 2017:estimates from global burden of disease2017[J]. J Diabetes Investig, 2021, 12(3):346-356.
[4]CHEN H, GUO J, ZHAO X, et al. Retrospective analysis of the overt proteinuria diabetic kidney disease in the treatment of modified Shenzhuo formula for 2 years[J].Medicine(United States), 2017, 96(12):e6349.
[5]CHEN HY, PAN HC, CHEN YC, et al. Traditional Chinese medicine use is associated with lower end-stage renal disease and mortality rates among patients with diabetic nephropathy:a population-based cohort study[J].BMC Complement Altern Med, 2019, 19(81):1-13.
[6]JUN M, TURIN TC, WOODWARD M, et al. Assessing the validity of surrogate outcomes for ESRD:a meta-analysis[J]. J Am Soc Nephrol, 2015, 26(9):2289-2302.
[7]LEVEY AS, GANSEVOORT RT, CORESH J, et al.Change in albuminuria and GFR as end points for clinical trials in early stages of CKD:a scientific workshop sponsored by the national kidney foundation in collaboration with the US Food and Drug Administration and European Medicines Agency[J]. Am J Kidney Dis, 2020, 75(1):84-104.
[8]蒋一佳,韦茂英,张文华,等.中医药治疗糖尿病肾脏病随机对照试验结局指标的现状分析[J].中国中药杂志,2024,49(24):6813-6824.
[9]王一帆,王希茜,申世雨,等.中药治疗糖尿病肾脏疾病随机对照试验结局指标的现状分析[J].中国实验方剂学杂志,2023,29(15):119-130.
[10]ZHANG L, YANG L, SHERGIS J, et al. Chinese herbal medicine for diabetic kidney disease:a systematic review and meta-analysis of randomised placebo-controlled trials[J]. BMJ Open, 2019, 9(4):e025653.
[11]Kidney Disease:Improving Global Outcomes(KDIGO)CKD Work Group. KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease[J]. Kidney Int, 2024,105(4S):S117-S314.
[12]CHAN KW, KWONG ASK, TSUI PN, et al. Add-on astragalus in type 2 diabetes and chronic kidney disease:a multi-center, assessor-blind, randomized controlled trial[J]. Phytomedicine,2024, 130:155457. doi:10. 1016/j. phymed. 2024. 155457.
[13]LEVEY AS, INKER LA, MATSUSHITA K, et al. GFR decline as an end point for clinical trials in CKD:a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration[J]. Am J Kidney Dis, 2014, 64(6):821-835.
[14]GREENE T, YING J, VONESH EF, et al. Performance of GFR slope as a surrogate end point for kidney disease progression in clinical trials:a statistical simulation[J].J Am Soc Nephrol, 2019, 30(9):1756-1769.
[15]QU YL, DONG ZY, CHENG HM, et al. Evaluation of renal impairment in patients with diabetic kidney disease by integrated Chinese and western medicine[J]. Chin J Integr Med, 2023, 29(4):308-315.
[16]曹灿,苏涛,尹新鑫,等.黄芪当归合剂治疗慢性肾脏病的中医疗效靶标研究[J].中国中西医结合肾病杂志,2021,22(11):968-971.
[17]LI P, CHEN Y, LIU J, et al. Efficacy and safety of tangshen formula on patients with type 2 diabetic kidney disease:a multicenter double-blinded randomized placebocontrolled trial[J]. PLoS One,2015,10(5):e0126027.
[18]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002.
[19]YANG H, XIA S, CONG Y, et al. Effects of Qidan Tangshen Granule on diabetic kidney disease in patients with type 2 diabetes[J]. Diabetes Res Clin Pract, 2024,209:111128. doi:10. 1016/j. diabres. 2024. 111128.
[20]ZHAO J, TOSTIVINT I, XU L, et al. Efficacy of combined abelmoschus manihot and irbesartan for reduction of albuminuria in patients with type 2 diabetes and diabetic kidney disease:a multicenter randomized double-blind parallel controlled clinical trial[J]. Diabetes Care,2022, 45(7):e113-e115.
[21]吴大嵘,郭新峰,赖世隆.生存质量评测及其在中医药疗效评价中的应用[J].广州中医药大学学报,2002,19(4):256-260.
[22]胡学军,商洪才,张伯礼,等.生存质量及其量表在中医药疗效评价中的应用[J].天津中医药,2004,21(3):191-193.
[23]周鑫,赵进喜,王世东,等.中医药综合治疗方案对糖尿病肾病患者生存质量的影响[J].中医杂志,2014,55(6):473-477.
[24]王娜,李杰静,唐崇淇,等.肾脏病治疗药物疗效评价指标的思考[J].中国药学杂志,2024,59(14):1283-1287.
[25]于东林,张启明,张磊,等.中医病机的内涵探讨[J].中医杂志,2014,55(6):537-538.
[26]卞立群,唐健元,訾明杰,等.功能性胃肠病临床疗效评价中症状学评价的若干问题[J].世界科学技术-中医药现代化,2020,22(10):3636-3639.
[27]张晓雨,田思超,尤良震,等.大数据时代中医症状疗效评价存在的问题与解决对策[J].中医杂志,2024,65(8):792-795.
[28]LO CT, SHESHADRI A, EDMONSON L, et al. Patientreported outcomes to achieve person-centered care for aging people with kidney disease[J]. Semin Nephrol,2024,44(3/4):151548.
[29]徐敏杰,董兴鲁,马亚男,等.《卒中后失语患者报告结局量表》第1版第1轮临床验证[J].中华中医药杂志,2021,36(11):6441-6446.
[30]张蕾,武志娟,张建伟.不孕症中医患者结局报告量表的研制与考评[J].中华中医药杂志,2022,37(9):5314-5318.
[31]卫梦雨,王佳佳,张莹莹,等.阻塞性睡眠呼吸暂停患者报告结局测评工具研究现状分析[J].中国全科医学,2023,26(30):3725-3733.
[32]罗建峰,侯江涛,侯政昆,等.基于中医理论构建炎症性肠病患者报告结局量表及条目筛选研究[J].中国全科医学,2022,25(29):3672-3677.
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)