Objective
A clinical control study was conducted to evaluate the efficacy and safety of gamma globulin pulse therapy combined with steroids and cyclophosphamide (CTX) in idiopathic membranous nephropathy (IMN) patients manifesting as nephrotic syndrome.
Methods
IMN patients retrospectively collected in our hospital from July 2008 to June 2012, were diagnosed according to urinary protein over 3.5 g/24 h, renal biopsy, and clinical features. The initial treatment was pulse gamma globulin[0.4 g / (kg·d) × 3 d] followed by enough prednisone [1 mg/(kg·d), maximum dose 80 mg/d] plus pulse CTX (0. 75 g/m2 BSA, 1 time / month × 6 times). After 2 months of enough dose therapy,prednisone was regularly reduced. These patients entered the gamma globulin group of 19 cases. the The control group also contained nineteen IMN patients matched by age, gender, and urinary protein level, who were treated with only oral prednisone plus pulse CTX. The whole course of treatment lasted 6 months in each group, and then the efficacy and safety were evaluated. The test data were analyzed with SPSS 16.0 statistical software. As for quantitative data expressed as mean ±standard deviation, differences between the two groups were compared with t test, while for count data expressed as number of cases (percentage),differences between the two groups were compared with the chi-square test. The endpoint result of follow-up after treatment was partial remission, which was expressed with Kaplan-Meier survival curve, and differences between the two groups were compared with log-rank test. A difference was considered statistically significant when P value was less than 0.05.
Results
After 6 months of treatment, the gamma globulin group showed complete remission in 4 cases (4/19,21.1%), and partial remission in 9 cases (9/19,47.4%), with an effective rate of 68.5% (13/19), while the control group showed complete remission in 3 cases (3/19,15.8%), and partial remission in 8 cases (8/19,42.1%),with an effective rate of 57.9% (11/19). The gamma globulin group achieved the partial remission in an average time less than the control group[(2.54 ± 1.39) months vs (3.73 ±1.50) months], which was statistically significant (χ2 =4.378,P＜0.05). No severe adverse events were observed during the treatment. The incidence of infection was significantly lower in gamma globulin group than in control group (χ2 =4.378,P ＜0.05).
Conclusions
The treatment of gamma globulin therapy combined with steroids and CTX was effective in reducing proteinuria of most IMN patients, and was with few infectious complications.