Exploration on Surrogate Outcome Measures in Clinical Trials of Traditional Chinese Medicine for Diabetic Kidney Disease
10.13288/j.11-2166/r.2025.08.006
- VernacularTitle: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
- Author:
Can CAO
1
;
Weiwei SUN
1
;
Tong MA
1
;
Yaoxian WANG
2
Author Information
1. Dongzhimen Hospital， Beijing University of Chinese Medicine （Tongzhou Branch），Beijing，101121
2. Dongzhimen Hospital，Beijing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
diabetic kidney disease;
outcome measures;
surrogate measures;
patient-reported outcomes;
quality of life;
traditional Chinese medicine symptoms
- From:
Journal of Traditional Chinese Medicine
2025;66(8):790-794
- CountryChina
- Language:Chinese
-
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-to-creatinine 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.
