Abstract:Objective To investigate the clinical efficacy of Huoxue Huayu Decoction combined with renin-angiotensin-aldosterone system（RAAS）inhibitors in the treatment of diabetic nephropathy（DN），and to observe its impact on oxidative stress-related indicators. Methods Eighty DN patients admitted to Lianyungang Hospital TCM Affiliated to Nanjing University of Chinese Medicine from June 2023 to March 2025 were selected and divided into two groups via random number table：the RAAS inhibitor group（n=40）was riven basic diabetes treatment and RAAS inhibitors，and the combined group（n=40）was given Huoxue Huayu Decoction on top of the treatment for the RAAS inhibitor group.The following indexes were compared between the two groups，including clinical efficacy，TCM syndrome scores，renal function indicators ［24-hour urinary protein quantification，urinary albumin/creatinine ratio （UACR），serum creatinine（Scr），blood urea nitrogen（BUN），glomerular filtration rate（GFR）］，and oxidative stress indicators［activities of superoxide dismutase（SOD）and glutathione peroxidase（GSH -Px），malondialdehyde（MDA）level］.Results The total effective rate of the combined group was higher than that of the RAAS inhibitor group（92.50% vs75.00%，χ2=4.501，P<0.05）. After treatment，the scores of primary and secondary syndromes in both groups were lower than those before treatment，and the scores in the Combined group were lower than those in the RAAS inhibitorgroup（P<0.05）. After treatment，the 24-hour urinary protein quantification，UACR，Scr，and BUN in both groups decreased compared with pre -treatment，while GFR increased，and the combined group had lower 24-hour urinaryprotein quantification，UACR，Scr，and BUN，and higher GFR than the RAAS inhibitor group，with statistically significant differences（P<0.05）. After treatment，the serum SOD and GSH-Px activities in both groups were higher than those before treatment，while the MDA level was lower，and the combined group had higher SOD and GSH-Pxactivities and lower MDA level than the RAAS inhibitor group，with statistically significant differences（P<0.05）.Conclusion Huoxue Huayu Decoction combined with RAAS inhibitors has a significant clinical effect in the treatment of DN，which can effectively improve patients renal function and reduce the level of oxidative stress.