Journal of Traditional Chinese Medicine >
Traditional Chinese herbal medicine Qingre Xiaozheng formula (清热消癥方) improves renal outcomes in patients with diabetic kidney disease: a retrospective study
Received date: 2024-04-22
Accepted date: 2024-11-25
Online published: 2025-07-25
Supported by
Capital Health Research and Development of Special(2016-1-4192);Beijing University of Chinese Medicine's 2022 Basic Research Business Fee Disclosure Leading Project(2022-JYB-JBZR-038)
OBJECTIVE: To assess the benefits of Qingre Xiaozheng formula (清热消癥方, QRXZF) as an adjunct to standard Western medical management on renal outcomes in patients with diabetic kidney disease (DKD).
METHODS: This retrospective study included patients with DKD who received the QRXZF between May 2017 and May 2021. A total of 144 patients with DKD, 24 h urinary total protein (24 h-UTP) ≥ 0.5 g, and estimated glomerular filtration rate (eGFR) ≥ 30 mL/min per 1.73 m2 were divided into the treatment group or the control group based on whether they received QRXZF treatment. The long-term renal outcomes of patients with DKD were analyzed to evaluate the effectiveness of the QRXZF. Differences in overall survival (OS) were assessed using Kaplan-Meier curve analysis. Cox proportional hazards regression analysis was used to determine the independent risk factors for renal endpoints.
RESULTS: The mean follow-up period was (28±15) months. Nine (12.5%) patients in the treatment group and 27 (37.5%) patients in the control group met the renal endpoints. Multivariate Cox regression analysis showed that 24 h-UTP ≥ 3.5 g [hazard ratio (HR) = 4.70, 95% confidence interval (CI) (1.83, 12.05), P = 0.001], combined coronary artery disease [HR = 3.39, 95% CI (1.65, 6.98), P = 0.001], total cholesterol [HR = 1.34, 95% CI (1.05, 1.70), P = 0.019] and low-density lipoprotein [HR = 1.65, 95% CI (1.111, 2.45), P = 0.013] were independent prognostic factors for renal endpoints in patients with DKD. Compared with the treatment group, the risk of renal endpoint events increased 2.68-fold in the control group [HR = 2.68, 95% CI (1.19, 6.02); P = 0.017]. We included 48 patients with 24 h-UTP ≥ 3.5 g in a further stratification analysis of patients with DKD. The independent risk factor for the renal endpoints in patients with 24h-UTP ≥ 3.5 g was smoking history [HR = 5.52, 95% CI (1.131, 26.92), P = 0.035]. Compared with the treatment group, the risk of renal endpoint events increased 3.01-fold in the control group [HR = 3.01, 95% CI (1.05, 8.67); P = 0.041].
CONCLUSIONS: The results show that QRXZF treatment improved renal outcomes and reduced proteinuria in patients with DKD. These results indicate that Traditional Chinese Medicine is likely to have a positive therapeutic effect on established and advanced DKD. Further well-designed clinical trials with longer follow-up periods are required.
Weiwei SUN , Jiale ZHANG , Hanwen YANG , Runze YAN , Shuwu WEI , Qiaoru WU , Zhaoli CUI , Huijuan ZHENG , Yaoxian WANG . Traditional Chinese herbal medicine Qingre Xiaozheng formula (清热消癥方) improves renal outcomes in patients with diabetic kidney disease: a retrospective study[J]. Journal of Traditional Chinese Medicine, 2025 , 45(4) : 873 -880 . DOI: 10.19852/j.cnki.jtcm.2025.04.017
| 1. | Zhang L, Long J, Jiang W, et al. Trends in chronic kidney disease in China. N Engl J Med 2016; 375: 905-6. |
| 2. | American Diabetes Association 11. Microvascular complications and foot care: standards of medical care in diabetes-2021. Diabetes care 2021; 44: S151-67. |
| 3. | M?ynarska E, Bu?awska D, Czarnik W, et al. Novel insights into diabetic kidney disease. Int J Mol Sci 2024; 25: 10222. |
| 4. | Miyamoto S, Heerspink HJL, de Zeeuw D, et al. A randomized, open-label, clinical trial examined the effects of canagliflozin on albuminuria and eGFR decline using an individual pre-intervention eGFR slope. Kidney Int 2024; 106: 972-84. |
| 5. | Fadini GP, Longato E, Morieri ML, et al. Comparative renal outcomes of matched cohorts of patients with type 2 diabetes receiving SGLT2 inhibitors or GLP-1 receptor agonists under routine care. Diabetologia 2024; 67: 2585-97. |
| 6. | McEwan P, Gabb PD, Davis JA, et al. The long-term effects of dapagliflozin in chronic kidney disease: a time-to-event analysis. Nephrol Dial Transplant 2024; 39: 2040-7.. |
| 7. | Green JB, Mottl AK, Bakris G, et al. Design of the combination effect of finerenone and empagliflozin in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE). Nephrol Dial Transplant 2023; 38: 894-903. |
| 8. | Zhang L, Miao R, Yu T, et al. Comparative effectiveness of Traditional Chinese Medicine and angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and sodium glucose cotransporter inhibitors in patients with diabetic kidney disease: a systematic review and network Meta-analysis. Pharmacol Res 2022; 177: 106111. |
| 9. | Wang B (Tang dynasty). Huang Di Nei Jing Su Wen. Beijing: People's Health Publishing House, 1963: 145. |
| 10. | Wang M, Wang Z, Zhou J, et al. Effects of traditional Chinese herbal medicine in patients with diabetic kidney disease: study protocol for a randomized controlled trial. Trials 2018; 19: 389. |
| 11. | Wang YX. Thirteen forms of treatment based on pathogenesis differentiation. Beijing: Chinese Press of Traditional Chinese Medicine, 2024: 219-29. |
| 12. | Gao YB, Guo J, Miao RP, et al. Wang Yaoxian's experience in the treatment of diabetic nephropathy by clearing heat and eliminating mass. Beijing Zhong Yi Yao 2020; 39: 152-4. |
| 13. | Wang XN, Wang YX, Yan RZ, Yang HW, Sun WW, Zhou JW. Clinical observation on the treatment of middle stage diabetic kidney disease with clearing heat and dispersing mass therapy. Zhong Hua Zhong Yi Yao 2020; 35: 5873-6. |
| 14. | Wang MD, Liu MC, Zhao WJ, Zhou JW, Wang YX. Improvement of proteinuria and effects on serum sTNFR1 and sTNFR2 in patients with diabetic kidney disease by Qingre Xiaozheng formula. Zhong Hua Zhong Yi Yao 2022; 37: 6183-8. |
| 15. | Wang YJ, Wang J, Zhou JW. Effect of Qingre Xiaozheng formula on improving renal injury in a rat model of diabetic kidney disease. Zhong Guo Quan Ke Yi Xue 2022; 25: 3678-85. |
| 16. | Wu Q, Yan R, Yang H, et al. Qing-Re-Xiao-Zheng-Yi-Qi formula relieves kidney damage and activates mitophagy in diabetic kidney disease. Front Pharmacol 2022; 13: 992597. |
| 17. | Chinese Diabetes Society. The consensus for prevention and treatment of diabetic kidney disease 2014. Zhong Hua Tang Niao Bing 2014; 6: 792-801. |
| 18. | Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease Kidney Int Suppl 2013; 31: 1-150. |
| 19. | Mogensen CE. Early renal involvement and nephropathy. Can treatment modalities be predicted from identification of risk factors in diabetics? Toxicol Lett 1989; 46: 213-26. |
| 20. | Mogensen CE, Schmitz A, Christensen CK. Comparative renal pathophysiology relevant to IDDM and NIDDM patients. Diabetes Metab Rev 1988; 4: 453-83. |
| 21. | The Diabetic Kidney Disease Group of Endocrine Committee of Chinese Association of Integrative Medicine and Chinese Medicine and Microcirculation Committee of the Chinese Society of Microcirculation. Expert consensus on the prevention and treatment of diabetic kidney disease with the integrated traditional Chinese and Western medicine (2023 edition). Zhong Hua Tang Niao Bing 2023; 15: 690-702. |
| 22. | Chen DQ, Wu J, Li P. Therapeutic mechanism and clinical application of Chinese herbal medicine against diabetic kidney disease. Front Pharmacol 2022; 13: 1055296. |
| 23. | 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. BMC Complement Altern Med 2019; 19: 81. |
| 24. | Guo JC, Pan HC, Yeh BY, et al. Associations between using Chinese herbal medicine and long-term outcome among pre-dialysis diabetic nephropathy patients: a retrospective population-based cohort study. Front Pharmacol 2021; 12: 616522. |
| 25. | Liu J, Zhang X, Xu G. Clinical efficacy, safety, and cost of nine Chinese patent medicines combined with ACEI/ARB in the treatment of early diabetic kidney disease: a network meta-analysis. Front Pharmacol 2022; 13: 939488. |
| 26. | Zhang W, Zhou J, Wang C, et al. Efficacy and safety of Keluoxin capsule in combination with Western Medicine for diabetic kidney disease: a systematic review and Meta-analysis. Front Pharmacol 2023; 13: 1052852. |
| 27. | Li W, Xia P, Sun W, et al. Effects of the Huangkui capsule on chronic kidney disease: a systematic review and Meta-analysis. J Tradit Chin Med 2023; 43: 6-13. |
| 28. | Wu C, Tang H, Cui X, et al. A single-cell profile reveals the transcriptional regulation responded for Abelmoschus manihot (L.) treatment in diabetic kidney disease. Phytomedicine 2024; 130: 155642. |
| 29. | 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. Phytomedicine 2024; 130: 155457. |
| 30. | Gao Y, Su X, Xue T, Zhang N. The beneficial effects of astragaloside IV on ameliorating diabetic kidney disease. Biomed Pharmacother 2023; 163: 114598. |
| 31. | Zhong Y, Lee K, Deng Y, et al. Arctigenin attenuates diabetic kidney disease through the activation of PP2A in podocytes. Nat Commun 2019; 10: 4523. |
| 32. | Zhang J, Li Y, Zhang F, et al. Hirudin delays the progression of diabetic kidney disease by inhibiting glomerular endothelial cell migration and abnormal angiogenesis. Biomed Pharmacother 2024; 179: 117300. |
| 33. | Long C, Zhang C, Xie Y. Study on the mechanism of hirudin multi target delaying renal function decline in chronic kidney disease based on the "gut-kidney axis" theory. Naunyn Schmiedebergs Arch Pharmacol 2024; 397: 7951-62. |
/
| 〈 |
|
〉 |