Clinical investigation of effect of leflunomide on lupus nephritis

CUI Li-fang; LENG Wei-xue; CHEN Ying; GU Hai-dong

doi:10.3760/cma.j.issn.1673-4777.2011.03.022

Abstract：Objective To observe the effect of new immunosuppressant leflunomide (LEF) for treatment of lupus nephritis(LN). Methods Fifty-one patients were divided into two groups randomly on principle of openess:LEF group with 27 cases and cyclophosphamide( CTX ) group with 24 cases. Two groups both were combined with prednisone for treatment of LN. Then the effect of two groups were observed by monitoring level change of the accumulate points of systemic lupus erythematosus disease activity index ( SLEDAI ), 24 hour urine protein, renal function, plasma albumin, immune body ANA titer, anti-ds-DNA titer and complement C3 and treatment effect before and after the treatment 1 month, 3 months and 6 months. And the adverse reactions are recorded respectively. Results The results show that LEF group was similar to CTX group with regard to clinical efficacy (77.8% vs 62.5% ). The difference was not statistically significant ( P ＞ 0. 05 ). Compared with every observation indicators of group 2 before treatment, the accumulate points of SLEDAI, 24 h urine protein quota, the blood plasma albumin level, the blood myo-bitter wine, the urea nitrogen value and the immunology index were obviously improved. And the difference was statistically significant (all P ＜ 0.05 ). And the longer the treatment time was, the more obviously all kinds of detection indexes were improved. The rate of adverse reactions (disgusting vomit, liver function harm,white blood cell reduction, hair losing, skin rash, diarrhea and abnormal menstruation) of LEF group[18.5% (5 cases), 11.1%(3 cases), 7.4%(2 cases), 0.0%( 0 case), 3.7%(1 case), 3.7%(1 case), 25.9%(7 cases)] were much less than that of CTX group [62.5% ( 15 cases), 37.5% (9 cases), 45.8% ( 11 cases), 20.8%(5 cases), 12.5% (3 cases), 16.7% (4 cases), 37.5% (9 cases)]. The difference were statistically significant ( all P ＜ 0.05 ). Conclusions LEF is similar to CTX with regard to clinical efficacy of the treatment of LN. Moreover, it is safer than CTX.