Ogura Yasuhiro, Imai Hisashi, Kamei Hideya, Hori Tomohide, Kurata Nobuhiko, Onishi Yasuharu
Department of Transplantation Surgery, Nagoya University Hospital, Nagoya, Japan.
Ann Transplant. 2016 Jul 19;21:448-55. doi: 10.12659/aot.898604.
BACKGROUND Prolonged-release tacrolimus (Tac QD) is widely used in organ transplantation. However, the conversion from twice-daily tacrolimus (Tac BID) to Tac QD in Japan is usually done in stable patients months or years after liver transplantation. The aim of this study was to assess the early conversion of Tac QD during liver transplant hospital stay. MATERIAL AND METHODS Eighteen liver transplants (excluding pediatric) were performed during 2014-2015. All cases except 2 early-expired patients were enrolled. Our standard immunosuppression is oral Tac BID and steroid taper, and we add mycophenolate mofetil if indicated. Conversion criteria from Tac BID to Tac QD were: 1) relatively stable liver function with stable trough level by oral Tac BID, and 2) good general condition (no or well-controlled complications). We did not fix the exact conversion date because each patient's recovery was different. Dose conversion rate from Tac BID to Tac QD was set at 1:1. RESULTS The median number of conversion days after liver transplant was 27 days. Sixty-two percent of patients were converted within 4 weeks after liver transplant, and 56% were discharged from the hospital within 2 weeks after conversion. The comparison of the last week of Tac BID and the first week of Tac QD revealed that the mean tacrolimus trough level declined by 30.4%, resulting in the 26.2% tacrolimus dose increase during the first 2 weeks after conversion. Adverse events after conversion were limited, and all patients show normal liver function to date. CONCLUSIONS Early Tac QD conversion is safe and feasible, but its long-term effects need further investigation.
背景 缓释他克莫司（他克莫司每日一次）广泛应用于器官移植。然而，在日本，从每日两次他克莫司（他克莫司每日两次）转换为他克莫司每日一次通常是在肝移植数月或数年的稳定患者中进行。本研究的目的是评估肝移植住院期间他克莫司每日一次的早期转换情况。 材料与方法 2014年至2015年期间进行了18例肝移植（不包括儿科）。除2例早期死亡患者外，所有病例均纳入研究。我们的标准免疫抑制方案是口服他克莫司每日两次和逐渐减量的类固醇，如果有指征则加用霉酚酸酯。从他克莫司每日两次转换为他克莫司每日一次的标准为：1）口服他克莫司每日两次时肝功能相对稳定且谷浓度稳定，2）一般状况良好（无并发症或并发症得到良好控制）。由于每个患者的恢复情况不同，我们没有确定确切的转换日期。从他克莫司每日两次到他克莫司每日一次的剂量转换率设定为1:1。 结果 肝移植后转换的中位天数为27天。62%的患者在肝移植后4周内完成转换，56%的患者在转换后2周内出院。他克莫司每日两次的最后一周与他克莫司每日一次的第一周比较显示，他克莫司平均谷浓度下降了30.4%，导致转换后前2周他克莫司剂量增加了26.2%。转换后的不良事件有限，所有患者目前肝功能均正常。 结论 早期转换为他克莫司每日一次是安全可行的，但其长期影响需要进一步研究。
