PDF(Pubmed)
Abstract：
UNASSIGNED: Previous trials comparing cyclosporine and tacrolimus after liver transplantation (LT) showed conflicting results. Most used trough monitoring for cyclosporine (C0), leading to less accurate dosing than with 2-h monitoring (C2). Only one larger trial compared C2 with tacrolimus based on trough level (T0) after LT, with similar treated biopsy-proven acute rejection (tBPAR) and graft loss, while a smaller trial had less tBPAR with C2 compared to T0. Therefore, it is still unclear which calcineurin inhibitor is preferred after LT. We aimed to demonstrate superior efficacy (tBPAR), tolerability, and safety of C2 or T0 after first LT.
UNASSIGNED: Patients after first LT were randomized to C2 or T0. tBPAR, patient- and graft survival, safety and tolerability were the main endpoints, with analysis by Fisher test, Kaplan-Meier survival analysis and log-rank test.
UNASSIGNED: In intention-to-treat analysis 84 patients on C2 and 85 on T0 were included. Cumulative incidence of tBPAR C2 vs. T0 was 17.7% vs. 8.4% at 3 months (p=0.104), and 21.9% vs. 9.7% at 6 and 12 months (p=0.049). One-year cumulative mortality C2 vs. T0 was 15.5% vs. 5.9% (p=0.049) and graft loss 23.8% vs. 9.4% (p=0.015). Serum triglyceride and LDL-cholesterol was lower with T0 than with C2. Incidence of diarrhea in T0 vs, C2 was 64% vs. 31% (p≤0.001), with no other differences in safety and tolerability.
UNASSIGNED: In the first year after LT immunosuppression with T0 leads to less tBPAR and better patient-/re-transplant-free survival as compared to C2.
UNASSIGNED: Patients after first LT were randomized to C2 or T0. tBPAR, patient- and graft survival, safety and tolerability were the main endpoints, with analysis by Fisher test, Kaplan-Meier survival analysis and log-rank test.
UNASSIGNED: In intention-to-treat analysis 84 patients on C2 and 85 on T0 were included. Cumulative incidence of tBPAR C2 vs. T0 was 17.7% vs. 8.4% at 3 months (p=0.104), and 21.9% vs. 9.7% at 6 and 12 months (p=0.049). One-year cumulative mortality C2 vs. T0 was 15.5% vs. 5.9% (p=0.049) and graft loss 23.8% vs. 9.4% (p=0.015). Serum triglyceride and LDL-cholesterol was lower with T0 than with C2. Incidence of diarrhea in T0 vs, C2 was 64% vs. 31% (p≤0.001), with no other differences in safety and tolerability.
UNASSIGNED: In the first year after LT immunosuppression with T0 leads to less tBPAR and better patient-/re-transplant-free survival as compared to C2.
摘要：
■先前比较肝移植（LT）后环孢素和他克莫司的试验显示出相互矛盾的结果。大多数用于环孢菌素（C0）的波谷监测，导致不太准确的剂量比2小时监测（C2）。只有一个较大的试验比较C2和他克莫司基于LT后的波谷水平（T0），经类似治疗的活检证实的急性排斥反应（tBPAR）和移植物丢失，而与T0相比，较小的试验对C2的tBPAR较少。因此,目前尚不清楚LT后哪种钙调磷酸酶抑制剂是首选.我们的目标是证明卓越的疗效（tBPAR），耐受性,以及第一次LT后C2或T0的安全性。
■第一次LT后的患者被随机分为C2或T0。tBPAR,患者和移植物存活，安全性和耐受性是主要终点，通过费舍尔检验分析，Kaplan-Meier生存分析和对数秩检验。
■在意向治疗分析中，纳入了84例C2和85例T0患者。tBPARC2的累积发病率与T0为17.7%vs.3个月时为8.4%(p=0.104)，和21.9%与6个月和12个月时为9.7％（p=0.049）。一年累计死亡率C2vs.T0为15.5%vs.5.9％（p=0.049）和移植物损失23.8％9.4%(p=0.015)。T0的血清甘油三酯和LDL-胆固醇低于C2。T0的腹泻发生率vs，C2为64%vs.31%(p≤0.001)，在安全性和耐受性方面没有其他差异。
■在LT免疫抑制后的第一年，与C2相比，T0导致更少的tBPAR和更好的患者/再移植生存。
■第一次LT后的患者被随机分为C2或T0。tBPAR,患者和移植物存活，安全性和耐受性是主要终点，通过费舍尔检验分析，Kaplan-Meier生存分析和对数秩检验。
■在意向治疗分析中，纳入了84例C2和85例T0患者。tBPARC2的累积发病率与T0为17.7%vs.3个月时为8.4%(p=0.104)，和21.9%与6个月和12个月时为9.7％（p=0.049）。一年累计死亡率C2vs.T0为15.5%vs.5.9％（p=0.049）和移植物损失23.8％9.4%(p=0.015)。T0的血清甘油三酯和LDL-胆固醇低于C2。T0的腹泻发生率vs，C2为64%vs.31%(p≤0.001)，在安全性和耐受性方面没有其他差异。
■在LT免疫抑制后的第一年，与C2相比，T0导致更少的tBPAR和更好的患者/再移植生存。
