| Objective:In order to study the efficacy and safety of tacrolimus(FK506)in the treatment of refractory nephrosis syndrome,we do a clinical observationof tacrolimus treating RNS by eigthteen children.Methods:Eigthteen children with refractory nephrosis syndrome enrolledfrom September2008to September2011into this retrospective longitudinalstudy in the pediatric nephrology of the first hospital Bethune jilin university.All children take in the treatment of tacrolimus combined with glucocorticoid,in which the tacrolimus initial dose is0.10to0.15mg/kg per day and onceevery12hours.If it is effective to oral tacrolimus after three months,and theycan continue to oral the quantity dose to six months, then according to the ruleto reduce gradually.The specific is reducing1/4of the initial dose each3mo-nths to drug withdrawal,and the total course of treatment is12to24months. Ifit is invalid after3months,then stop to oral other immunosuppressive agents.At the same time,they take orally prednisone1.0to1.5mg/kg qod,and reduceby the way of reducing2.5mg each2weeks and maintaining when it ireduce to0.5mg/kg qod.During the treatment period,we should observe the changes suchas24hours Urine protein,creatinine (SCr), albumin (Alb), cholesterol (Chol),triglycerides (TG),fasting blood glucose,liver enzymes, routine blood and urinewhen the patients take the medicine1st week,2nd week,3rd week,4rd week,8thweek,10th week,12th week,16th week,20th week and24th week.Meanwhile,weshould detect the concentration of the FK506and tune-up the concentrationaccording to the result and sustain it range from5-12ng/L.To analyze and eva-luate the efficacy and safety of tacrolimus in the treatment of refractory nephr- osis syndrome in children.All of them signed written informed consent form,ready to participate in this study before treatment.Results:(1) General situation: We choosed the18patients,among of them，eigth are male,the others are female,age from3to15years old,and the averageage (6.67±3.29) year old;course of disease from1.5month to27months,andthe average course of disease (9.58±7.14) month;eigth are simple type NS,theothers are nephritic type NS;nine are hormone drug-resistant nephrotic syndr-ome,four are hormone dependence on nephritic syndrome,and another arefrequency recurrence nephrotic syndrome.Nine patients received renal biopsy,of whom5revealed mesangial proliferative glomerulonephritis,2revealed min-imal change nephropathy;other1children with IgA nephropathy and1focalsegmental glomerulosclerosis.Among ten nephritic type NS children,9areaccompanied by hematuria and5are hypertension.Twelven children areexamined the T cell subgroup,10CD8+advances and the other CD4+markup.Among eighteen patients,15cases showed complete remission,2cases had par-tial remission,another is out of service.And the total effectiveness is94.4%.After applicating by FK506,the time of patients’median of urinary proteinnegative is31(2~182) days.Nine children received the treatment of Cycloph-osphamide pulse were invalid,and get good efficacy after oraling FK506,inwhich7showed complete remission,1cases had partial remission and1isinvalid,and the total effectiveness is88.9%.(2)Relationship between clinicalclassification and efficacy:after statistical analysis,there is no difference inefficacy of between tacrolimus in treatment simple and nephritis NS,and amongSRNS,FRNS and SDNS simultaneously.(3)Changes of urinary protein: comp-ared to before treatment,the quantifications of urinary proteinthe are signific-antly decreased after4th weeks,8th weeks,12th weeks and24th weeks, and allof P are less than0.01.(4)Changes of blood biochemical index: compared tobefore treatment,the albumin level significantly increased (P＜0.01),cholesterol and triglyceride decline(P＜0.05),serum creatinine and eGFR are notsignificantly changed (P＞0.05).after4th weeks,8th weeks,12th weeks and24thweeks.(5)Relationship between T cell subsets and efficacy:there is no differe-nces between FK506in treatment of CD8+advances and the other CD4+markup in children(P＞0.05).(6)Efficacy of different Pathological type NS inchildren:there is no differences among tacrolimus in treatment of variouspathological type NS(P＞0.05).(7)18children receive effective blood drugconcentration of tacrolimus is (7.74+1.63)ug/L, which is controlled at the rangeof5~12ng/L,and it can maintain a good healing efficacy.(8)Among18children,2cases occur adverse reaction,and2patients the disease relapsed3times remaining18cases were followed up from6months to30months.Conclusion:(1)FK506combined with glucocorticoid in treatment refract-tory nephrosis is effective, save time and improve the alleviate rate.(2) There isno difference in efficacy of between tacrolimus combined with glucocorticoidin treatment simple and nephritis NS, and among SRNS,FRNS and SDNSsimultaneously.(3)FK506combined with glucocorticoidin treatment of refract-ory nephrosis has the very good security.(4)There is no differences betweenFK506combined with glucocorticoid in treatment of CD8+advances and theother CD4+markup in children. |
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