Abstract:

Objective: Diabetes mellitus is increasing in prevalaence worldwide, and diabetic nephropathy is the most common cause of end-stage renal disease. Because the proteinuria of diabetic patients is an independent risk factor for progression, so the treatment goal is to reduce proteinuria as much as possible. To date, some clinical trials had shown that Angiotensin II Receptor Blockers (ARB) was effective in reducing proteinuria in diabetic nephropathy, but its effects were not satisfactory. So we designed this clinical trial to evaluate the clinical effects of Tripterygium wilfordii (TW) treatment for patients with type 2 diabetic nephropathy (DN) who have heavy proteinuria. Methodology: Sixty-five patients with DN whose proteinuria more than 2.5g/24hr, serum creatinine less than 3mg/dl, younger than 70 years old and have no cardiovascular event in the past six months, were enrolled in this study. They were randomized divided into two groups, TW treatment group:34 patients, TW 120mg/d for 3 months, and then tapered to maintenance dose of 60mg/d for 3 months; ARB control group:31 patients, Valsartan 160mg/d for 6 months. At the end point, we evaluate the decrease of proteinuria, the increasement of Serum creatinine and the side effects of TW. We also observed the clinical and pathological factors which influence the therapeutic effect. Results: At the treatment endpoint, the proteinuria was dramaticly decreased in TW group compared with baseline(4.99±2.25g/24h vs 2.99 ±1.81g/24h，P<0.01),and the percentage of the decrease at month 1 ,3 ,6 was 32.9%,38.8%,34.3% respectively. But the proteinuria of ARB group was not decreased significantly, the percentage of the decrease were 1.05%,10.1%,-11.7% respectively. The increase ratio of Scr in ARB group was significantly higher than TW group(36.9% vs 20.3%，P<0.05）and the decrease ratio of eGFR in ARB group was significantly higher than ARB group（24.6% vs 13.7%，P<0.05）. No statistics difference of side effects were observed between the two groups. Conclusion: Tripterygium wilfordii was a novel effective and safe drug for treatment of DN patients with heavy proteinuria.