他克莫司在移植肾功能延迟恢复患者中的临床应用

A pilot clinical study of tacrolimus(FK506) in cadavaric renal transplant recipients with delayed graft function and early acute rejection

目的 :探讨他克莫司 (FK5 0 6 )在移植肾功能延迟恢复 (DGF)患者中的临床应用价值与合理用药方案。 方法 :17例DGF患者临床结合移植肾病理确立诊断。肾移植术后早期均接受三联 (FK5 0 6 +MMF +Pred)免疫抑制药物治疗至少 3个月。不用任何生物制剂诱导治疗 ,观察临床疗效及副作用。 结果 :17例患者无一例死亡或摘除移植肾。 15例在术后第 2～ 3天开始血液透析 (HD) /连续性血液净化 (CBP)治疗 ,2例在术后第 5天开始HD/CBP。HD/CBP治疗 2～ 15次后 ,10例在术后 7天内停止 ,7例在术后 7天后仍需CBP治疗 ,最长 1例在术后第 18天停止透析。FK5 0 6治疗后 8～ 17天患者尿量开始明显增多 ,SCr开始明显下降。 17例患者诊断DGF时SCr水平在4 89～ 10 2 8μmol/L ,14例在治疗后 8～ 17天降至 <2 0 0 μmol/L ,另 3例中 2例SCr分别在术后第 2 4天 ,2 8天降至 <2 0 0 μmol/L。副作用主要是腹泻 (3例 ) ,血糖升高 (1例 )及手颤 ,肢体麻木 (4例 ) ,但未出现CMV等严重感染病例。 结论 :FK5 0 6 +MMF +Pred三联免疫抑制治疗方案治疗肾移植DGF安全有效 。

Objective:To investigate the clinical effects of the FK506+MMF+Pred regimen [Tacrolimus (FK506) in combination with mycophenolate mofetil (MMF) and prednisone] in patients with delayed graft functioning(DGF) and early acute rejection after allograft transplantation. Methodology:Seventeen patients with DGF and early acute rejection after cadaver kidney transplantation were reviewed in this study. They were 14 males and 3 females aged 24-50 years. DGF was diagnosed with clinical and laboratory data, and pathohistologic findings in allograft biopsy. DGF was defined by serum creatinine (SCr) over 400 μmol/L, needing renal replacement therapy [routine hemodialysis or continous blood purification(CBP)] for more than 1 time within 1 week after receiving the transplants. The causes for DGF included acute tubular necrosis (ATN) in 2 cases, ATN and early acute rejection in 15 cases. All of those patients received the immunosppresive regime: FK506(0.15 mg/(Kg·d) combined with MMF(1.5-2.0 g/d)and prednisone, while ATG,ALG,OKT3 or IL-2 recipte antagonium were not prescribed in any of the patients. The effects of this immunosuppressive regimen were observed prospectively for more than 3 months. Results:There was no death observed in these 17 recipients, nor severe allograft dysfunctioning needing removement of the allograft.In 10 of the recipients, HD/CBP was needed for 7 days; while in the other 7 recipients, HD/CBP was needed for 8-18 days. Increment of urine volume and marked decrement of SCr were observed after 8-17 days'FK506 treatment. Within 8-17 days, SCr decreased to a level below 200 μmol/L in 14 cases with a pretreatment level of SCr between 480-1028 μmol/L. No reoccurrence of allograft dysfunction and acute rejection observed during the treatment. The trough level of blood concerntration of FK506 varied between 3.7-13.6 ng/ml (averaged )within the first 2 weeks, 3.2-14 ng/ml (averaged 6.8 ng/ml) in the following 2 months, 4.6 ng/ml (3.6-8.5 ng/ml) in the third month after transplantation. Diarrhea and increased the level of blood sugar were observed as the side-effects, while no severe infections observed. Conclusion: FK506 combined with MMF and Prednisone (FK506+MMF+Pred) is effective and safe in the management of patients with DGF after cadaveric renal allograft transplantation.