This study aimed to assess the clinical efficacy and safety of the treatment of refractory nephrotic syndrome with integrated traditional Chinese and western medicine.

The study was a prospective, randomized, double-blind, 2∶1 basic-control, multi-center clinical trial, with 120 patients recruited from 7 hospitals in China. The test group was administered with traditional Chinese medicine (TCM) particles on the base of prednisone and cyclophosphamide treatment for 3 months, while the control group was administered with placebo using the same method. The 24-hour urinary protein, serum albumin, serum creatinine, TCM syndrome score and adverse reactions were monitored timely. SPSS 20.0 software was used for data analysis.

At 3 months, the total effective rate was 89.39% and 63.64% for the test and the control, respectively, the difference of which was of statistical significance (χ²=7.824, P=0.005). The total effective rate of TCM syndromes was 93.94% and 72.73% for the test and the control, respectively, the difference of which was also of statistical significance (χ²=6.918, P=0.009). The incidence of Cushing′s syndrome, digestive tract reactions, and infections in the test group were lower than in the control group, the difference of which was of statistical significance (χ²=7.666, P=0.006; χ²=5.088, P=0.024; χ²=5.227, P=0.022).

Treatment with integrated traditional Chinese and western medicine effectively improved the clinical efficacy of refractory nephrotic syndrome, improved the clinical symptoms, and reduced the side effects of immunosuppressive agents.