Comparison of efficacy of tacrolimus and cyclophosphamide in the treatment of frequently relapsing and steroid-dependent nephrotic syndrome in children

JIANG Luo; YU Li; YU Sheng-you; HAO Zhi-hong

Abstract：Objective To compare the clinical efficacy and safety of tacrolimus ( FK506) and cyclophosphamide ( CTX) in the treatment of steroid-dependent and frequently relapsing nephrotic syndrome ( SDNS/FRNS) in children. Methods The analysis of 38 cases of SDNS/FRNS, whom were assigned into FK506 group ( n=21 ) and CTX group (n=17), was conducted.On the basis of oral prednisolone, the patients were given with oral tacrolimus 0.1-0.15 mg/( kg· d) in FK506 group, and intravenous cyclophosphamide 8-10 mg/( kg· d) in CTX group.The total course were at least 1 year.The frequency of recurrence, the steroid dose changes and the biochemical indicators 6 and 12 mouths after treatment were compared, and the adverse reactions were recorded.Results In FK506 group, the relapse frequency from was significantly reduced from ( 5.7 ±2.8 ) times/year to ( 1.2 ±0.7 ) times/year, as the steroid dose from ( 37.9 ± 15.3) mg/d to (14.6 ±8.3) mg/d (P<0.01).In CTX group, the relapse frequency was significantly reduced from 4.8 ±2.5 times/year to (1.0 ±0.6) times/year (P<0.01), as the steroid dose from (35.3 ±14.2) mg/d to (12.4 ± 7.8) mg/d ( P<0.01).After treatment, the biochemical indicators were significantly improved than baseline ( P <0.05), while there was no significant difference between the two groups (P>0.05).Gastrointestinal reactions were re-ported in 2 patients in FK506 group, while gastrointestinal reactions, peripheral blood hypoleukcytosis and transaminase elevation were reported in 4, 1 and 1 patients, respectively, in CTX group, whom were improved after symptomatic treat-ment.No serious infection was reported.Conclusion Both tacrolimus and cyclophosphamide can achieve similar results in the treatment of SDNS/FRNS, including reduction in relapse frequency and steroid use.In view of the good therapeutic effect, fewer side effects and no damage to the gonads in FK506, especially in children with puberty stage, FK506 is ad-vocated for replacement of CTX in the treatment.