中老年肾移植患者早期撤除激素的免疫抑制方案研究

目的 评价中老年肾移植患者早期撤除激素的安全性及有效性. 方法 80例中老年肾移植患者随机分为撤激素组39例和常规治疗组41例.所有患者开始均采用环孢素A(CsA)+吗替麦考酚酯(MMF)+泼尼松(Pred)三联免疫抑制方案,Pred开始剂量为20 mg/d,撤激素组Pred逐渐减量(每周减量5 mg),术后1个月停用;常规治疗组Pred 3个月后减量为10 mg/d,6个月后减为5 mg/d维持.MMF、CsA起始用量相同.随访观察患者急性排斥反应(AR)发生率、移植肾功能、人存活率、肾存活率,感染情况、血糖、血压、体质量、血脂等指标. 结果 撤激素组、常规治疗组AR发生率相似(分别为23.1%和19.5%,χ~2=0.15,P>0.05).两组患者1、2、3年人存活率分别为97.4%、94.8%、88.0 0A和97.6%、97.6%、87.8%,差异无统计学意义(χ~2=0.1 7,P>0.05);肾存活率分别为94.9%、88.6%、83.7%和95.1%、91.5%、79.5%,差异无统计学意义(χ~2=0.07,P>0.05). 结论 老年肾移植患者早期撤除激素是可行的.

A randomized prospective study of early steroid withdrawal in middle aged and elderly renal transplant patients

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 Then prednisone (Pred) 20 mg daily was gradually tapered and withdrawn after postoperative day 30.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.