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将他克莫司制剂由每日两次给药改为每日一次在小儿肝移植受者中的应用:一项长期前瞻性研究。

Conversion from twice-daily to once-daily tacrolimus formulation in pediatric liver transplant recipients - a long-term prospective study.

机构信息

Pediatric Hepatology and Liver Transplant Unit, Hospital Universitari de la Vall d'Hebron, Universitat Atònoma de Barcelona, 08036, Barcelona, Spain.

Hepatology and Liver Transplant Unit, Hospital Universitari de la Vall d'Hebron, Universitat Atònoma de Barcelona, 08036, Barcelona, Spain.

出版信息

Transpl Int. 2018 Jan;31(1):38-44. doi: 10.1111/tri.13037. Epub 2017 Sep 27.

DOI:10.1111/tri.13037
PMID:28833714
Abstract

To assess the safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus in pediatric liver transplant recipients. Conversion from twice-daily to once-daily tacrolimus was made in stable pediatric liver transplant recipients. Doses and serum levels of tacrolimus, liver, and renal function were recorded on the day before the conversion and at days 5, 30, 90, and 180 postconversion. Patients were controlled every 2-3 months thereafter. Fifty-five patients were enrolled in the study. The mean age at conversion was 10.2 ± 3.6 years. The mean tacrolimus trough level was 4.7 ± 1.9 ng/dl preconversion, followed by a significant decline to 4.2 ± 1.7 30 days after the switch (P < 0.004). Mean daily tacrolimus dose was 0.09 ± 0.046 mg/Kg preconversion with a significant increase to 0.11 ± 0.060 3 months postconversion (P < 0.001). Fifteen patients with calculated glomerular filtration rate between 60 to 80 ml/min/m preconversion showed a significant improvement one and 3 years after the switch (73 ± 4.1, 83 ± 4.3 and 90.3 ± 7.3 ml/min/m , respectively (P < 0.001). The mean follow-up was 5.2 ± 2.4 years. Conversion to once-daily tacrolimus is safe and effective in a cohort of stable pediatric liver transplant patients.

摘要

评估将每日两次的他克莫司转换为每日一次在小儿肝移植受者中的安全性和疗效。在稳定的小儿肝移植受者中进行从每日两次到每日一次的他克莫司转换。在转换前一天和转换后第 5、30、90 和 180 天记录他克莫司的剂量和血清水平、肝肾功能。此后每 2-3 个月对患者进行一次控制。共有 55 名患者入组研究。转换时的平均年龄为 10.2 ± 3.6 岁。转换前他克莫司谷浓度的平均值为 4.7 ± 1.9ng/dl,转换后 30 天显著下降至 4.2 ± 1.7ng/dl(P < 0.004)。转换前平均每日他克莫司剂量为 0.09 ± 0.046mg/Kg,转换后 3 个月显著增加至 0.11 ± 0.060mg/Kg(P < 0.001)。转换前肾小球滤过率(GFR)在 60-80ml/min/m 之间的 15 名患者在转换后 1 年和 3 年时显示出显著改善(分别为 73 ± 4.1、83 ± 4.3 和 90.3 ± 7.3ml/min/m,P < 0.001)。平均随访时间为 5.2 ± 2.4 年。在稳定的小儿肝移植患者队列中,将他克莫司转换为每日一次是安全有效的。

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引用本文的文献

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Tacrolimus and Sirolimus Once Daily Monotherapy Regimen as a Safe and Effective Long-Term Maintenance Immunosuppressive Therapy in Pediatric Liver Transplantation.他克莫司和西罗莫司每日一次单药治疗方案作为小儿肝移植安全有效的长期维持免疫抑制疗法
Int J Organ Transplant Med. 2020;11(4):177-184.
2
Efficacy and safety of prolonged-release tacrolimus in stable pediatric allograft recipients converted from immediate-release tacrolimus - a Phase 2, open-label, single-arm, one-way crossover study.延长释放型他克莫司在由即时释放型他克莫司转换而来的稳定儿科移植受者中的疗效和安全性 - 一项 2 期、开放标签、单臂、单向交叉研究。
Transpl Int. 2019 Nov;32(11):1182-1193. doi: 10.1111/tri.13479. Epub 2019 Aug 27.