Abstract:Objective To observe the clinical efficacy and safety of Qiling HushenFormula on proteinuria and renal function in patients with type 2 diabetic kidney disease（T2DKD）of dampness-stasis obstructing collaterals syndrome. Methods A total of 380 T2DKD patients admitted to the Department of Endocrinology, Jiangsu Provincial Hospital of Chinese Medicine from August 2022 to August 2025 were enrolled. They were divided into the Chinese medicine group and the control group according to whether Qiling Hushen Formula was taken, with 190 cases in each group. The control group was given simple basic western medicine treatment, while the Chinese medicine group was given Qiling Hushen Formula on the basis of control group. The course of treatment for both groups was 12 weeks. Changes in urinary albumin-to -creatinine ratio（UACR）, estimated glomerular filtration rate（eGFR）, glucose and lipid metabolism indicators including fasting blood glucose（FBG）, glycosylated hemoglobin（HbA_1C）, total cholesterol（TC）, low-density lipoprotein cholesterol（LDL - C）and total score of Chinese medicine syndromes were observed in the two groups of T2DKDpatients before and after treatment, and the occurrence of adverse event reactions and conduct statistics were recorded. Results During the clinical study, 25 patients in the Chinese medicine group dropped out or were excluded and 165cases completed the trial. In the control group, 26 patients dropped out or were excluded and 164 cases completed the trial. After treatment, the UACR level of T2DKD patients in both groups was significantly lower than that before treatment（P＜0.05）, and the decreasing range in the Chinese medicine group was significantly better than that in the control group（P＜0.01）. There was no significant difference in UACR of patients in stage A2 of the control group before and after treatment（P＞0.05）, while the UACR of patients in stage A2 of the Chinese medicine group was significantly decreased after treatment compared to before treatment（P＜0.01）. After treatment, the UACR of patients in stage A3 of both groups was significantly lower than that before treatment（P＜0.05）, and the decreasing range in the Chinese medicine group was still significantly better than that in the control group（P＜0.01）. According to the subgroup analysis of eGFR level by GA stage, there was no significant difference in eGFR between before and after treatment and between the two groups in both the control group and the Chinese medicine group（P＞0.05）. After treatment, HbA_1C in both groups was lower than that before treatment（P＜0.05）；TC and LDL-C in the Chinese medicine group after treatment were lower than those before treatment（P＜0.05）, while there was no statistically significant difference between the two groups（P＞0.05）. The total score of Chinese medicine syndromes in both groups decreased after treatment, and the total score in the Chinese medicine group was significantly lower than that in the control group（11.6±3.6 vs 17.2±6.2, t=9.991, P＜0.01）.The total incidence of adverse reactions was 5.45%（9/165）in the Chinese medicine group and 3.05%（5/164）in the control group, and there was no statistically significant difference between the two groups（χ²=1.168, P=0.280）.Conclusion Compared with simple basic western medicine treatment, Qiling Hushen Formula combined with basic western medicine treatment was confirmed to significantly reduce the UACR level proteinuria of T2DKD patients and effectively improve clinical symptoms with good safety.