Comparison Of Clinical Efficacy And Safety Of Cyclosporine A And Tacrolimus In The Treatment Of Children With Frequently Relapsing Or Steroid-Dependent Nephrotic Syndrome

Steroid-sensitive nephrotic syndrome(SSNS)accounts for the majority of primary nephrotic syndrome(PNS)in childhood,about half of them developed steroid-dependent nephrotic syndrome(SDNS)or frequently relapsing nephrotic syndrome(FRNS).For these children,the use of glucocorticoid alone is not effective,and once associated with adverse hormone reactions,drugs need to be changed.Currently,immunosuppressive drugs are commonly used in clinical treatment.This study aimed to compare the clinical efficacy and safety of cyclosporin A(CsA)and tacrolimus(TAC)in the treatment of children with FRNS/SDNS through retrospective analysis.Objective:To investigate the clinical efficacy and safety of cyclosporine A and tacrolimus in the treatment of FRNS/SDNS in children.Methods:We retrospective analyzed 71 children with FRNS/SDNS who were visited the pediatric outpatient clinic of the Affiliated Hospital of Chengde Medical College from September 2018 to September 2022.According to the choice of CsA or TAC treatment,they were divided into CsA group(36 cases)and TAC group(35 cases).Data were collected for the two groups:steroid dose before treatment and 12 months;the levels of serum albumin(Alb),serum cholesterol(TC),blood urea(Urea),24-hour urine protein quantification(UPRO)before treatment,3 months,6 months,and 12 months;the estimated glomerular filtration rate(e GFR)before treatment,6 months,12 months;the complete remission rates and the average efficacy at 3months,6 months,and 12 months of treatment between groups;the complete remission rates and the average efficacy between groups with different pathological types were treated at 3 months,6 months,and 12 months.Observe the occurrence of adverse reactions such as infection in the two groups during treatment.Kaplan-Meier survival analysis was used to compare the maintenance complete remission rates of the two groups of NS children,and the survival curve was plotted.P<0.05 was statistically significant.Results:1.General data of the two groups were compared:there were no significant differences between groups in age,age of onset,gender composition,course of disease,initial steroid dose,e GFR,Alb,TG,TC,Urea,and UPRO(P>0.05).2.At 12 months follow-up,the steroid dose of CsA group and TAC group was significantly reduced,the difference was statistically significant(P<0.001),and there was no statistically significant between the two groups(P>0.05).3.Compared with the clinical data of the two groups:at 3 months of treatment,the level of Alb was significantly higher than before,and the level of TC and UPRO were significantly reduced compared with before treatment(P<0.001),and there was no significant difference between groups(P>0.05),and there was no significant change in Urea,and the difference was not statistically significant(P>0.05).At 6 months of treatment,Alb in TAC group was significantly higher than that in CsA group,and UPRO level was significantly lower than that in CsA group(P<0.05),the levels of TC and Urea between the two groups were not statistically significant(P>0.05);and at 12 months of treatment,the indicators of Alb,Urea,TC and UPRO were no significantly different between the two groups(P>0.05).4.At the 6 month of treatment,the complete remission rate and average efficacy in the TAC group were significantly higher than those in the CsA group,and there was significant difference between the two groups(P<0.05).At 12 months of treatment,there were no significant differences in complete remission rate and average efficacy between the two groups(P>0.05).Kaplan-Meier survival analysis showed that there was no significant difference between the two groups for maintaining complete response rate(Log-rank?~2=0.524,P=0.469).At 12 months of treatment,there was no significant difference in e GFR between the two groups(P>0.05).5.The incidence of hirsutism in the CsA group was significantly higher than that in the TAC group,the difference was statistically significant(P<0.05),there was no significant difference in the incidence of nine adverse reactions include infection(P>0.05).Conclusions:For children with FRNS/SDNS,CsA and TAC have good efficacy,but TAC has better short-term(6 months)efficacy than CsA,and CsA and TAC have similar efficacy in adjuvant steroid dose reduction and maintenance of remission,but it is still necessary to pay close attention to the occurrence of adverse drug reactions of CsA and TAC.