| Background: Henoch-Schonleinpurpura nephritis is a common secondary glomerulonephritiscaused by allergic purpura.HSPN is often manifested as hematuria,proteinuria.partial patients may be accompanied by hypertension and renal insufficiency.HSPN patients classified in type III-V according to International Study of Kidney Disease in Children(ISKDC)had a worse outcomewhen compared to type I-II.However,if HSPN patients of type III-V are treated properly,it may delay the deterioration of renal function.Treatment for HSPNhas not yet reached a consensus.There aremany small-scale clinical studies about treatment effect on HSPN with glucocorticoid combined with tacrolimus(TAC)and Mycophenolatemofetil(MMF).The efficacy and side effects were different.Since the kidney transplantation are carrying outin our department,we have a long history of use for these two immunosuppressive agents.According to the mechanism of the medicine and foreign studies,we also have used glucocorticoid combined with these two kinds of immunosuppressive for treatment of HSPN and the outcome are sati sfactory especially in patients showing poor response to conventional immunosuppressive drugs,or serious drug side effects.However,the efficacy and safety of glucocorticoid combined with two special immunosuppressive agents for thetreatment of HSPN is no t reported yet.Therefore,we retrospectively compared the efficacy and safety of glucocorticoid combined with TAC or MMF for the treatment of III-V type HSPN,aiming at provide theoretical basis for which immunosuppressive regimen should be choosed for th e treatment of HSPN.Due to the difficulty to monitor the MMF blood concentration in the clinical and the lack of data on the area under the MMF plasma concentration curve,we can not study the relationship between MMF plasma concentration and adverse reac tions.In order to analyze the toxic side effects in TACtrough concentration of blood,we will study the relationship between TAC blood trough concentration and adverse reaction in renal transplant patients who is treated with higher doses and have higher blood trough concentration than HSPN.Objectives:1.To compare the efficacy of glucocorticoid combined with TAC or MMFfor the treatment of type HSPN III-V.2.To compare the safety of glucocorticoid combined with TAC or MMF for the treatment of type HSPN III-V.To compare the safety of TAC between low blood trough concentration and the high blood trough concentration.3.To provide a theoretical basis for clinical treatment options.MethodsAccording to inclusion criteria and exclusion criteria,we totally screened out 58 samples of pathological type of III-V of HSPN in our hospital from January 2012 to November 2015.Patients were divided into two groups,one groupof full-dose hormone combined with TAC,the other group of full-dose hormone combined with MMF.Hormone combined with TAC group of 30 cases were treated with prednisone in dose of 1mg/(kg·d)-1and1.5mg/(kg·d)-1for children with TAC in dose of 0.05~0.1mg/(kg·d)-1twice daily.TAC blood trough concentration were controlled in 4-8ng/ml.Weaslo named it as TAC high blood trough concentration group.Hormone combined with MMF group of 28 caseswere treated with prednisone in dose of 1mg/(kg·d)-1and1.5mg/(kg·d)-1for children with MMF in dose of 0.75 ~ 1.0 g/d twicedaily.We retrospectively collected the clinical data before and after treatment:(1)general situation: fever,rash,abdominal pain,joint pain et al;(2)auxiliary examination results: serum creatinine(Scr),proteinuria,serumalbumin(Alb),red blood cell count of urinary sedimentundermicroscopicexamination,estimated glomerular filtration rate(e GFR)et al;(3)remission rate,the average remission time,the incidence of adverse reactions;(4)results of repeated renal biopsy.We retrospectively collected 29 patients with kidney transplantation from Decembe r 2013 to January 2017 in our hospital.We regard it as the third group and named as TAC high blood trough concentration group.All patients with renal transplantation weretreatedwiththree kinds of immunosuppressive regimens: TAC,MMF and hormones.All patients received oral TAC 0.08-0.15mg/Kg/d twice a day.The dose of oral TAC in the patients with kidney transplantation was 4 mg / d higher than that in the HSPN group and the blood concentration of TAC was controlled at 8-12 ng / ml.We retrospectively collected the relationship between TAC plasma concentration and adverse reactions : bone marrow suppression,liver damage,hyperlipidemia,New-onset diabetes after transplantation(NODAT),gastrointestinal reactions,neurological toxicity and nephrotoxicity.We compared the incidence of adverse reaction of TAC in different blood concentrationResults:1.Comparison of curative effect between two groups in HSPN patients.There was significant difference between the two groups(P<0.05)after the treatment in the urine protein quantitation,Alb,urinary sediment microscopic examination,but no significant difference in each group(P>0.05).And there were no significant difference in Scr and e GFR between the two groups or in each group before and after treatment(P>0.05).It had no significant difference in remission rate and remission time between sufficient hormone combined with TAC group and sufficient hormone combined with MMF group(P>0.05).2.Comparison of adverse reactions of TAC and MMF in HSPN.In HSPN,there were 7 cases of adverse reaction in 30 cases treated with adequate hormone combined with TAC,and the incidence was 23.3%.Of the 7 patients,High blood glucoseoccured in 3 cases,tremor in 2 cases,alopecia and headache in 1 case.In the group of adequate hormone combined with MMF,there were 5 cases of cough,3 cases of insomnia,2 cases of hypercholesterolemiaand 1 case of hypertension,pulmonary infection,dyspepsia,nausea and vomiting respective.And the incidence rate of adverse reaction was 50%.There was significant difference between the two groups(x2 =4.459,P=0.035).3 Adverse reactions of TAC in renal transplantation patientsIn 29 cases of renal transplant recipients,23 cases had adverse reactions.15 cases only had 1 kind of adverse reactions,in which hyperlipidemia had occured in 10 cases,NODAT in 3 cases,each of the diarrhea and liver function damage in 1 case.7 cases had 2 kinds of adverse reactions,in which renal toxicity,bone marrow suppression or tremor complicated with hyperlipidemia had occured in 1 case respectively.2 cases occurred concurrently with hyperlipidemia and diarrhea,tremor combined with nephrotoxicity in 1 case.There is 1 case occurred with renal toxicity,NODAT and diarrhea at the same time.The totally incidence of adverse events was 79.2%,higher than the incidence of HSPN(P = 0.000).Conclusion1.Glucocorticoid combined with TAC is non-inferior to glucocorticoid combined with MMF for therapy of henoch-schonleinpurpura nephritis(pathological type ?-?).2.In HSPN,Glucocorticoid combined with TAC group had lower incidence of adverse reactions than glucocorticoid combined with MMF group.In patients with kidney transplantation,the blood concentration of TAC and the incidence of adversereactions were higher than HSPN group.3.The incidence of side effects is relatively low for monitoring TAC plasma concentration.While it's difficult to monitor the blood concentration curve area of MMF,there may be more adverse reactions in MMF group.We think thatglucocorticoid combined with TAC is more superior than glucocorticoid combined with MMF for treatment of HSPN(pathological type III-V). |
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