OBJECTIVE: To investigate the effectiveness safety and tolerance of mycophenolate mofeil(MMF) in severe IgA nephropathy and evaluate the dosage adjustment and course for clinical treatment. METHODS:62 patients with IgA nephropathy diagnosed by renal biopsy as Lee's grade IV and V with urinary protein > 2.0 g/d were enrolled randomly in the trial. The initial dosage of MMF was 1.0 g/d (body weight < 50 kg) or 1.5 g/d (body weight > 50 kg). The dosage was reduced to 0.75 approximately 1.0 g/d after 6 months treatment, the maintaining dosage was 0.5 approximately 0.75 g/d after 12 months. The total course of treatment lasted at least 12 months. Another 31 patients matched with age gender and severity of renal damage were given prednisone orally (0.8mg(;)kg(;)d) (control group).Blood and urinary tests hepatic and renal function plasma albumin serum triglyceride and cholesterol24 h protein excretion urinary NAG enzyme, creatinine clearance(Ccr) were performed before and 3 6 12 18 months after treatments in both groups 5 patients in MMF group received repeated renal biopsy. RESULTS: (1) After 3 months treatment, decrease of urinary protein (1.9 g/24 h +/- 1.6 g/24 h vs 3.2 g/24 h +/- 1.7 g/24 h, P < 0.01) and improvement of plasma albumin (41 g/L +/- 6 g/L vs 37 g/L +/- 6 g/L, P < 0.01) were observed in MMF groups while in control group, no significant changes were found in uinary protein (2.3 g/24 h +/- 1.8 g/24 h vs 2.9 g/24 h +/- 1.5 g/24 h, P < 0.05) and plasma albumin (40 g/L +/- 6 g/L vs 37 g/L +/- 6 g/L, P < 0.05). After treatment for 6, 12 and 18 months, both group showed obvious alleviation of proteinuria and albumin. At the 12th and 18th month, the proteinuria in MMF group was significantly improved than that in control group (0.8 g/24 h +/- 0.8 g/24 h vs 1.4 g/24 h +/- 1.6 g/24 h and 0.6 g/24 h +/- 0.7 g/24 h vs 1.4 g/24 h +/- 1.3 g/24 h, P < 0.05 respectively). The remission rate and total effective rate of MMF group were higher than those of the control group (44.4% vs 19.1% and 88.9% vs 61.9%, P < 0.05 respectively). Patients were administered with MMF for 13.8 +/- 6.3 months (6 approximately 30 m). (2) Serum cholesterol and triglyceride were remarkably reduced after 6,12 and 18 months treatment in MMF group, no significant difference was found in control group(P < 0.05). (3) For the 6 patients with renal insufficiency in MMF group, MMF treatment was significantly effective in 1 patient, effective in 2 patients, not effective in 3 patients with an overall effective rate of 50%. For the 7 patients with renal insufficiency in control group, the treatment was significantly effective in 1 patient, effective in 1 patient, not effective in 5 patients and total effective rate is 28.6%. (4) 5 patients in MMF group received repeated renal biopsy after 7 approximately 12 months treatment (mean 9.8 +/- 2.3 m). The results showed that the interstitial lesions were alleviated. No special drug-induced renal damage was obtained. (5) Side effects: 3 patients in MMF group suffered from slight diarrhea, 1 patient herpes zoster, all of them got remission without drug withdrawal. 1 patient suffered nausea in the first weeks. No significant change was found in hepatic function (P > 0.05). CONCLUSIONS:MMF is more effective in reducing proteinuria and serum lipid than the currently widespread use of prednisone therapy in IgA nephropathy patients with Lee SMK's grade IV approximately V and urinary protein > 2.0 g/d. Treatment with MMF associates with less adverse effect and good tolerance.
RCT Entities:
OBJECTIVE: To investigate the effectiveness safety and tolerance of mycophenolate mofeil(MMF) in severe IgA nephropathy and evaluate the dosage adjustment and course for clinical treatment. METHODS: 62 patients with IgA nephropathy diagnosed by renal biopsy as Lee's grade IV and V with urinary protein > 2.0 g/d were enrolled randomly in the trial. The initial dosage of MMF was 1.0 g/d (body weight < 50 kg) or 1.5 g/d (body weight > 50 kg). The dosage was reduced to 0.75 approximately 1.0 g/d after 6 months treatment, the maintaining dosage was 0.5 approximately 0.75 g/d after 12 months. The total course of treatment lasted at least 12 months. Another 31 patients matched with age gender and severity of renal damage were given prednisone orally (0.8mg(;)kg(;)d) (control group).Blood and urinary tests hepatic and renal function plasma albumin serum triglyceride and cholesterol 24 h protein excretion urinary NAG enzyme, creatinine clearance(Ccr) were performed before and 3 6 12 18 months after treatments in both groups 5 patients in MMF group received repeated renal biopsy. RESULTS: (1) After 3 months treatment, decrease of urinary protein (1.9 g/24 h +/- 1.6 g/24 h vs 3.2 g/24 h +/- 1.7 g/24 h, P < 0.01) and improvement of plasma albumin (41 g/L +/- 6 g/L vs 37 g/L +/- 6 g/L, P < 0.01) were observed in MMF groups while in control group, no significant changes were found in uinary protein (2.3 g/24 h +/- 1.8 g/24 h vs 2.9 g/24 h +/- 1.5 g/24 h, P < 0.05) and plasma albumin (40 g/L +/- 6 g/L vs 37 g/L +/- 6 g/L, P < 0.05). After treatment for 6, 12 and 18 months, both group showed obvious alleviation of proteinuria and albumin. At the 12th and 18th month, the proteinuria in MMF group was significantly improved than that in control group (0.8 g/24 h +/- 0.8 g/24 h vs 1.4 g/24 h +/- 1.6 g/24 h and 0.6 g/24 h +/- 0.7 g/24 h vs 1.4 g/24 h +/- 1.3 g/24 h, P < 0.05 respectively). The remission rate and total effective rate of MMF group were higher than those of the control group (44.4% vs 19.1% and 88.9% vs 61.9%, P < 0.05 respectively). Patients were administered with MMF for 13.8 +/- 6.3 months (6 approximately 30 m). (2) Serum cholesterol and triglyceride were remarkably reduced after 6,12 and 18 months treatment in MMF group, no significant difference was found in control group(P < 0.05). (3) For the 6 patients with renal insufficiency in MMF group, MMF treatment was significantly effective in 1 patient, effective in 2 patients, not effective in 3 patients with an overall effective rate of 50%. For the 7 patients with renal insufficiency in control group, the treatment was significantly effective in 1 patient, effective in 1 patient, not effective in 5 patients and total effective rate is 28.6%. (4) 5 patients in MMF group received repeated renal biopsy after 7 approximately 12 months treatment (mean 9.8 +/- 2.3 m). The results showed that the interstitial lesions were alleviated. No special drug-induced renal damage was obtained. (5) Side effects: 3 patients in MMF group suffered from slight diarrhea, 1 patient herpes zoster, all of them got remission without drug withdrawal. 1 patient suffered nausea in the first weeks. No significant change was found in hepatic function (P > 0.05). CONCLUSIONS:MMF is more effective in reducing proteinuria and serum lipid than the currently widespread use of prednisone therapy in IgA nephropathypatients with Lee SMK's grade IV approximately V and urinary protein > 2.0 g/d. Treatment with MMF associates with less adverse effect and good tolerance.