A randomized prospective study of early steroid withdrawal in middle aged and elderly renal transplant patients / 中华老年医学杂志

ABSTRACT

Objective To evaluate the safety and validity of an early steroid withdrawal protocol including cyclosporine (CsA) and mycophenolate mofetil (MMF) in middle aged and elderly renal transplant patients. Methods Between September 2000 and April 2008, the prospective, randomized study design was used in 80 middle aged and elderly renal transplant patients. Steroid withdrawal group (n=39) with primary cadaveric kidney transplants received a protocol consisting of CsA 4～6 mg·kg~(-1)·d~(-1) beginning at postoperative day 3, MMF 0. 75 g twice a day from the next postoperative day, and methylprednisolone (MP) 500 mg daily from day 0 to 3. Then prednisone (Pred) 20 mg daily was gradually tapered and withdrawn after postoperative day 30. Conventional steroid treatment group (control group, n=41) received a regimen consisting of CsA, MMF and MP, and Pred 20 mg daily. Pred was tapered to 5 mg daily over a period of 6 months, then maintained thereafter. Outcome parameters were patient and graft survival rates, renal function, acute rejection ( AR), arterial hypertension, hyperlipidemia or diabetes mellitus, weight gain and infection. Results The incidence of AR in the steroid withdrawal group was similar to the control group (23. 1% vs. 19. 5%, χ~2=0. 15,P>0. 05). Patient survival rates at 12, 24, 36 months were 97. 4%, 94. 8% and 88.0% in the steroid withdrawal group and were 97.6%, 97.6 and 87.8% in the control group, respectively (χ~2=0. 17, P>0. 05). And graft survival rates were 94. 9%, 88. 6% and 83. 7% in the steroid withdrawal group and were 95. 1%, 91. 5% and 79. 5% in control group, respectively (χ~2 = 0.07, P>0. 05). Conclusions In middle aged and elderly renal transplant patients, early steroid withdrawal is feasible and may not significantly increase the risk of acute rejection episodes.