Objective
To observe the safety and efficacy of Jianpibushentongluo granules plus prednisone in treating immunoglobulin A nephropathy (IgAN) patients staging Lee Ⅲ and above(Pishenyangxu pattern).
Methods
A randomized, controlled, and double-blind multicentre clinical trial was conducted. From January 2011 to February 2012, a total of 120 IgAN patients (Lee Ⅲand above) from 4 hospitals in Shanghai were recruited. All of the patients presented with Pishenyangxu syndrome. The patients were randomly divided into two groups: test group (Jianpibushentongluo granules plus prednisone)and control group (placebo granules plus prednisone). According to the patient's weight and renal function,the starting dose of oral prednisone was 40-60 mg/d for a total of 8 to 12 weeks; Thereafter, the oral prednisone dose was reduced by 5 mg every two weeks until the dose reached 30 mg/d, and then by 5 mg every month. Oral prednisone was stopped after 9 months of treatment. The Jianpibushentongluo granules were made from astragalus,sealwort,eucommia,prunella,fried caltrop,epimedium,poria,fried silkworm,and salvia, which were administered to patients for 48 weeks. Follow-up was performed at the 0,4,12,24,36, and 48 week, monitoring estimated glomerular filtration rate (eGFR), symptoms of traditional Chinese medicine, serum creatinine, and 24-hour urinary protein excretion. Mixed model was used for analysis of repeated measuring data to compare efficacy difference between the two groups. P value less than 0.05 was considered statistically significant.
Results
103 patients (test group 55 cases, control group 48 cases)completed the study. eGFR in both test and control group showed an increasing trend compared with baseline(t=4.84,2.37;P＜0.05); eGFR level became higher at 24-week of treatment (P＜0.05), and increased more from baseline in test group than in control group at 48-week of treatment (F=14.39, P＜0.05). The syndrome scoring and 24 h urinary protein in both groups were lower than baseline (t= -12.1,-8.6;P＜0.05). The syndrome scoring decreased more in test group than in control group (F=106.76, P＜0.05),but the 24 h urinary protein decreased more in control group than in test group (F =46.24,P ＜0.05).Serum creatinine level decreased significantly than baseline in test group (t= -4.34,P＜0.05),but not in control group (t = -1.12,P >0.05). The total effective rate of syndromes treatment was higher in test group (83.33%,50/60) than in control group (63.33%, 38/60) (χ2 =17.85, P ＜0.05). Adverse events occurred in 14 cases: test group 5 cases (5/60, 8.3%), and control group 9 cases (9/60,15%)with no statistically significant difference between the two groups (χ2 =1.294, P=0.255).
Conclusion
For IgAN patients staging Lee Ⅲand above (Pishenyangxu pattern), Jianpibushentongluo granules plus prednisone showed better efficacy and safety than prednisone alone in improving renal function and reducing clinical symptoms.