Management And Safety Of Steroid Withdrawal In Patients With End-stage Diabetic Nephropathy After Simultaneous Pancreas-kidney Transplantation

Objective.To observe and summarize the clinical management experience and clinical efficacy of glucocorticoid withdrawal in patients with end-stage diabetic nephropathy(ESDN)after simultaneous pancreas-kidney(SPK)transplantation,and to evaluate the safety of postoperative steroid withdrawal.Methods.Retrospectively analyzed the clinical data of 81 recipients who underwent simultaneous pancreas-kidney transplantation for end-stage diabetic nephropathy at the Organ Transplantation Center of the Second Affiliated Hospital of Guangzhou Medical University from January 2020 to January 2022,and set 29 recipients who completed glucocorticoid withdrawal within 3 months after surgery as early withdrawal group,22 recipients who completed steroid withdrawal within 3-10 months after surgery as nonearly withdrawal group,and another 30 recipients who maintained long-term oral steroid immunosuppression regimen after surgery as maintenance group.Summarized the perioperative and follow-up immunosuppression regimen,complications and clinical management strategies of each group;compared the transplant kidney,transplant pancreas function indicators,complications of each group,and evaluated the safety of steroid withdrawal.Results.All recipients received triple immunosuppression regimen(tacrolimus +mycophenolate mofetil + prednisone)after surgery.After strict clinical management,glucocorticoid withdrawal was completed without increasing the dose of tacrolimus and mycophenolate mofetil;there was no statistical difference in tacrolimus blood concentration among the three groups.There was no statistical difference in the incidence of complications among the groups within 3 months after surgery,and the complications did not further lead to recipient death or graft loss after treatment.In terms of clinical efficacy and safety,all patients completely got rid of exogenous insulin dependence after surgery.At the end point of this study,the fasting blood glucose levels of early withdrawal group,non-early withdrawal group and maintenance group were(5.62±0.81)mmol/L,(5.72±0.87)mmol/L and(5.79±0.65)mmol/L(P=0.311),respectively.There was no statistical difference in hemoglobin A1 c,fasting C-peptide level,plasma insulin level,blood amylase and urine amylase among the three groups.The estimated glomerular filtration rate at 12 months after surgery was(95.95±32.10)m L/min,(98.41±24.64)m L/min and(94.90±24.75)m L/min(P=0.596)for early withdrawal group,non-early withdrawal group and maintenance group respectively.The serum creatinine levels at 12 months after surgery were(124.09±22.29)μmol/L,(125.31±28.43)μmol/L and(122.09±23.87)μmol/L(P=0.118)for the three groups respectively.Urinary protein positive was 1 case(3.4%)in early withdrawal group,2cases(9.1%)in non-early withdrawal group and 2 cases(6.7%)in maintenance group(P=0.848).After 3 months postoperatively,the infection rates of early withdrawal group,non-early withdrawal group and maintenance group were 6.9%,15.4% and 16.7%(P=0.378),respectively;the rejection rates were 6.9%,4.5% and 13.3%(P=0.613),respectively.After steroid withdrawal,early withdrawal group had one case of transplant pancreas rejection reaction and one case of transplant kidney rejection reaction,which were reversed after treatment and graft function was stable during follow-up period.Conclusion.Under strict clinical management,steroid withdrawal after simultaneous pancreas-kidney transplantation for end-stage diabetic nephropathy patients can maintain graft function stability without increasing anti-rejection drug dose.After completing steroid withdrawal,it does not affect the survival rate of recipients and grafts,has no effect on transplant pancreas and transplant kidney function,does not increase the incidence of adverse reactions,individualized steroid withdrawal is safe and feasible.