To explore the clinical efficacy of Tongxuan Qishen formula (clearing Xuan and activating kidney Therapy) in treating diabetic nephropathy (DN) patients with spleen and kidney deficiency, blood stasis and water stagnation syndrome.

A total of 85 patients with diabetic nephropathy who met the criteria of spleen and kidney deficiency, blood stasis and water stagnation syndrome, admitted to Wangjing Hospital of China Academy of Chinese Medical Sciences from January 2022 to April 2024, were randomly divided into a control group (receiving basic treatment) and an treatment group (receiving basic treatment + clearing Xuan and activating kidney Therapy). The treatment group consisted of 43 patients, and the control group had 42 patients. The clinical symptoms, FIB-4 index, glucose and lipid metabolism-related indicators [glycated hemoglobin (HbA1c), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)], renal function indicators [24-hour urine total protein (24h UTP), estimated glomerular filtration rate (eGFR), serum creatinine (Scr), blood urea nitrogen (BUN), and uric acid (UA)], and safety indicators were observed and compared between the two groups before and after treatment.

After 12 weeks of intervention, the clinical treatment effective rate in the treatment group was 90.7% (39/43), significantly higher than the 64.3% (27/42) in the control group (P < 0.01). The Traditional Chinese Medicine (TCM) syndrome scores in the observation group decreased significantly (P <0.01), while in the control group, although there was a reduction in scores, the difference was not statistically significant (P > 0.05). Following treatment, the FIB-4 index decreased in both groups, but the improvement in the treatment group was significantly better than that in the control group (P < 0.05, P < 0.01). The lipid profile improvement in the treatment group was significantly better than that in the control group(P < 0.05). Specifically, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the treatment group decreased significantly (P <0.01), triglycerides (TG) decreased markedly (P <0.05), and high-density lipoprotein cholesterol (HDL-C) showed slight improvement but the difference was not statistically significant (P >0.05). In the control group, TC decreased significantly (P < 0.05), but the reductions in TG, HDL-C, and LDL-C were not statistically significant (P >0.05). The HbA1c levels in the treatment group decreased significantly (P <0.05), while no significant improvement was observed in the HbA1c levels of the control group (P >0.05). The estimated glomerular filtration rate (eGFR) in the treatment group increased significantly (P < 0.05), while 24-hour urine total protein (24h UTP), serum creatinine (Scr) and uric acid (UA) decreased significantly (P < 0.05). No significant improvement was observed in blood urea nitrogen (BUN) (P > 0.05). In the control group, although there were improvements in 24h UTP, eGFR, Scr, BUN, and UA, the differences were not statistically significant (P > 0.05).

Tongxuan Qishen formula can significantly improve the FIB-4 index, renal function, and metabolism-related clinical indicators in DN patients with spleen-kidney deficiency, blood stasis and water stagnation syndrome. It reduces the accumulation of metabolic products in the human body and plays an important role in reducing the risk of liver fibrosis, improving renal function, and delaying disease progression.