A Study Of Low-dose Cyclophosphamide Combined With Mycophenolate Mofetil For Induction Therapy Of Lupus Nephritis

Objective:TO investigate the clinical efficiency and safety of induction therapy of low-dose Cyclophosphamide combined with low-dose Mycophenolate mofetil(CTX+MMF) on patients with Lupus Nephritis(class III, IV, V, V+III and V+IV),compared to Cyclophosphamide (CTX) therapy and Mycophenolate mofetil (MMF) therapyMethods:137patients were randomized to the CTX Group (n=48), MMF group (n=43) and low-dose CTX+MMF group (n=46), The induction course of treatment was set to6months, the patients who with lupus crisis received intravenous methylprednisolone pulse therapy0.5g/day, for3days at the beginning. All patients were treated with Oral prednisone tablets0.8-1.0mg/(kg.d), and gradually reduced the dose after4-8weeks. MMF group was given MMF1.5-2g/d, divided into2times, CTX group was given CTX monthly0.8-1.0g, the low-dose CTX+MMF group was given MMF1.0g/d, divided into2times and intravenous CTX0.6g/month. We evaluated the remission rates by detecting the24-hour urinary protein excretion, serum albumin, Serum creatinine, and compared the changes of ESR, C3, ds-DNA of the immunological indicators.Results:(1) Remission rates:After6months of treatment, the the complete remission rates of the CTX group, MMF group and the low-dose CTX+MMF was46.5%,46.3%,56.5%, the CTX+MMF is higher than the other two groups, the total remission rates (complete remission rates+partial remission rates) of three groups was:74.4%,80.4%,82.6%, the difference among such groups was not statistically significant (P>0.05).(2)Immunological indicators:after six months the positive rates of ant-ds-DNA was32.6%,36.6%,30.4%,the difference between groups was not statistically significant (P>0.05), C3and ESR was statistically significant (p<0.05) compared with before, no statistically significant difference among the groups.(3) Pathological types:The CTX+MMF had a good efficacy on every types of Lupus Nephritis, the complete remission rate of Class IV was60.8%, higher than the CTX group and the MMF group, but no statistical significance (P>0.05).(4) Adverse Events:5patients discontinued treatment in MMF group:3cases due to infection,2cases due to amenorrhea, and2patients discontinued treatment in MMF group due to infenction. The main adverse envents of CTX+MMF include: gastrointestinal disorders, infections, compared with the CTX group and the MMF group, the difference was statistically significant (P<0.05). there was no serious infections and deaths.Conclution:1. Compare the immunosuppressive therapy of lupus nephritis, the complete remission rate of low-dose CTX+MMF induction therapy higher than CTX or MMF.2. the Adverse Events of Low-dose CTX+MMF induction therapy for lupus nephritis was less than CTX and MMF,and well tolerated.