Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Division of Liver Transplantation and Hepatobiliary Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Transplant Proc. 2021 Dec;53(10):3000-3006. doi: 10.1016/j.transproceed.2021.09.043. Epub 2021 Nov 11.
Simplifying immunosuppressive therapy after liver transplant may improve patient compliance, thereby preventing acute rejection and graft loss. This phase 4, open-label, single-center study was conducted to evaluate the efficacy and safety of twice-daily to once-daily tacrolimus conversion in stable liver transplant recipients.
Between May 2017 and January 2019, twice-daily tacrolimus was converted to once-daily tacrolimus in 101 stable recipients at least 12 months post-liver transplant in Asan Medical Center. The doses of both drugs was converted to 1:1, and the target trough level was 5 to 10 ng/mL. We prospectively analyzed graft function, drug compliance, and adverse reactions after switching regimen for 24 weeks.
There was no acute rejection confirmed histologically within 24 weeks, which was the primary endpoint, and there was no chronic rejection, fatal deterioration of liver function, or death in any patient during this period. After conversion, the trough level of tacrolimus decreased, and the mean ± standard deviation differences between the trough level and baseline level were 1.46 (±2.41) ng/mL, 0.43 (±2.08) ng/mL, and 0.07 (±2.73) ng/mL at 3, 12, and 24 weeks after conversion, respectively. Despite transient fluctuations of the trough level, there was no evidence of rejection or graft dysfunction. There were 37 adverse reactions after conversion; most of them were mild, and thrombocytopenia developed in 1 patient as an adverse drug response. Drug compliance improved after conversion according to questionnaire responses.
The conversion to once-daily tacrolimus in stable liver transplant recipients is an effective and safe therapeutic strategy improving drug compliance.
简化肝移植后的免疫抑制治疗可能会提高患者的依从性，从而预防急性排斥反应和移植物丢失。本 4 期、开放标签、单中心研究旨在评估稳定肝移植受者由每日两次给予他克莫司转换为每日一次的疗效和安全性。
2017 年 5 月至 2019 年 1 月，101 例肝移植后至少 12 个月的稳定受者在 Asan 医疗中心将每日两次给予他克莫司转换为每日一次给予他克莫司。两种药物的剂量均转换为 1:1，目标谷浓度为 5 至 10ng/ml。我们前瞻性分析了转换方案后 24 周时的移植物功能、药物依从性和不良反应。
在 24 周内没有确认组织学上的急性排斥反应，这是主要终点，在此期间没有发生慢性排斥反应、肝功能致命恶化或死亡。转换后，他克莫司的谷浓度降低，转换后 3、12 和 24 周时谷浓度与基线水平的平均差异（±标准偏差）分别为 1.46（±2.41）ng/ml、0.43（±2.08）ng/ml 和 0.07（±2.73）ng/ml。尽管谷浓度存在短暂波动，但没有排斥或移植物功能障碍的证据。转换后有 37 例不良反应；大多数为轻度，1 例患者出现血小板减少症作为药物不良反应。根据问卷调查，转换后药物依从性提高。
在稳定的肝移植受者中转换为每日一次给予他克莫司是一种有效且安全的治疗策略，可提高药物依从性。
