Objective  To observe the clinical efficacy of Yiqi Yangyin Tongluo Recipe in the treatment of patients with diabetic nephropathy (DN) in stage Ⅲ to Ⅳ differentiated as syndrome of deficiency of qi and yin complicated with blood stasis.

  Methods  Totally 80 patients with DN in stage Ⅲ to Ⅳ differentiated as syndrome of deficiency of qi and yin complicated with blood stasis were randomly divided into control group and observation group, with 40 cases in each group. Both groups were conducted with conventional treatment, the control group was treated with benazepril, and the observation group was treated with Yiqi Yangyin Tongluo Recipe. The TCM syndrome score, clinical efficacy, serum creatinine, urea nitrogen, 24 h urinary protein quantification, microalbuminuria, ratio of microalbuminuria to creatinine (ACR), serum tumor necrosis factor-α (TNF-α) and C reactive protein (CRP) were compared between the two groups before and after treatment.

  Results  After treatment, the TCM syndrome score of the observation group was (11.90±2.30) points, which was significantly lower than (16.70±6.30) points of the control group (P < 0.05). The total effective rate was 82.50% in the observation group, which was significantly higher than 40.00% in the control group (P < 0.05). After treatment, levels of 24 h urinary protein quantification, microalbuminuria, ACR, serum creatinine and urea nitrogen in the observation group were significantly lower than those in the control group (P < 0.05). After treatment, CRP and TNF-α in both groups were lower than those before treatment, and the CRP and TNF-α in the observation group were significantly lower than the control group (P < 0.05). There were no obvious adverse reactions during treatment in both groups.

  Conclusion  Yiqi Yangyin Tongluo Recipe can significantly improve the symptoms and signs of DN patients, reduce proteinuria, improve renal function, delay the progression of DN, and has no obvious adverse reactions.