Altieri Mario, Delaval Guillaume, Kimmoun Elisabeth, Allaire Manon, Salamé Ephrem, Dumortier Jérôme
>From the service d'Hépato-Gastroentérologie, Nutrition et Oncologie Digestive, Hôpital Côte de Nacre, Caen, France.
Exp Clin Transplant. 2018 Jun;16(3):321-325. doi: 10.6002/ect.2016.0328. Epub 2017 Jul 11.
After organ transplant, strategies to simplify the therapeutic regimen may improve adherence and prevent rejection and/or graft loss. The aim of the present study was to evaluate the safety of conversion from once-daily prolonged-release tacrolimus (Advagraf; Astellas Pharma Europe Limited, Middlesex, UK) to once-daily extended-release tacrolimus (Envarsus; Chiesi SAS, Nanterre, France) in stable adult liver transplant recipients.
This observational study inclu-ded 44 liver transplant patients (median age of 59 y; 63.6% men; median delay after transplant of 72.5 mo). Conversion was based on a 1:0.70 proportion.
Mean dose of tacrolimus was 2.65 ± 1.24 mg/day before conversion and 2.09 ± 1.68 mg/day after conversion (P < .05), with ratio of 1:0.79. Mean serum tacrolimus trough level increased after conversion (4.92 ± 1.65 vs 5.60 ± 2.89 ng/mL; P < .05), with ratio of 1:1.14. Six months after conversion, mean dose of tacrolimus was 1.65 ± 0.93 mg/day (ratio of 1:0.62) and mean serum tacrolimus trough level was 4.82 ± 1.85 ng/mL, similar to the initial level before conversion. At the end of follow-up, 2 patients had returned to once-daily prolonged-release tacrolimus because of adverse effects (allergy, digestive trouble), which resolved thereafter. The mean cost of tacrolimus therapy was 5.54 ± 2.29 Euros/patient/day before conversion and 4.11 ± 2.32 Euros/patient/day after conversion (P < .05).
Conversion from prolonged-release to extended-release tacrolimus in stable liver transplant patients is safe and cost-effective; however, initially, dose adaptations and careful monitoring are required.
器官移植后，简化治疗方案的策略可能会提高依从性并预防排斥反应和/或移植物丢失。本研究的目的是评估稳定的成年肝移植受者从每日一次的缓释他克莫司（Advagraf；阿斯利康制药欧洲有限公司，英国米德尔塞克斯）转换为每日一次的延长释放他克莫司（Envarsus；基耶西制药公司，法国楠泰尔）的安全性。
这项观察性研究纳入了44例肝移植患者（中位年龄59岁；63.6%为男性；移植后中位时间为72.5个月）。转换基于1:0.70的比例。
转换前他克莫司的平均剂量为2.65±1.24mg/天，转换后为2.09±1.68mg/天（P<.05），比例为1:0.79。转换后他克莫司的平均血清谷浓度升高（4.92±1.65对5.60±2.89ng/mL；P<.05），比例为1:1.14。转换6个月后，他克莫司的平均剂量为1.65±0.93mg/天（比例为1:0.62），平均血清他克莫司谷浓度为4.82±1.85ng/mL，与转换前的初始水平相似。随访结束时，2例患者因不良反应（过敏、消化系统问题）恢复使用每日一次的缓释他克莫司，此后症状缓解。转换前他克莫司治疗的平均费用为5.54±2.29欧元/患者/天，转换后为4.11±2.32欧元/患者/天（P<.05）。
在稳定的肝移植患者中，从缓释他克莫司转换为延长释放他克莫司是安全且具有成本效益的；然而，最初需要调整剂量并进行仔细监测。
