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他克莫司缓释胶囊在肾移植术后的早期应用

邹志宇, 陈松, 昌盛, 等. 他克莫司缓释胶囊在肾移植术后的早期应用[J]. 器官移植, 2023, 14(2): 257-264. doi: 10.3969/j.issn.1674-7445.2023.02.012
引用本文: 邹志宇, 陈松, 昌盛, 等. 他克莫司缓释胶囊在肾移植术后的早期应用[J]. 器官移植, 2023, 14(2): 257-264. doi: 10.3969/j.issn.1674-7445.2023.02.012
Zou Zhiyu, Chen Song, Chang Sheng, et al. Early application of tacrolimus extended-release capsule after kidney transplantation[J]. ORGAN TRANSPLANTATION, 2023, 14(2): 257-264. doi: 10.3969/j.issn.1674-7445.2023.02.012
Citation: Zou Zhiyu, Chen Song, Chang Sheng, et al. Early application of tacrolimus extended-release capsule after kidney transplantation[J]. ORGAN TRANSPLANTATION, 2023, 14(2): 257-264. doi: 10.3969/j.issn.1674-7445.2023.02.012

他克莫司缓释胶囊在肾移植术后的早期应用

doi: 10.3969/j.issn.1674-7445.2023.02.012
基金项目: 

中国器官移植发展基金会“移植领创计划2021” YZLC-2021-005

详细信息
    作者简介:
    通讯作者:

    张伟杰,教授,主任医师,博士研究生导师,研究方向为器官移植与免疫,Email:wjzhangtj@126.com

  • 中图分类号: R617, R979.5

Early application of tacrolimus extended-release capsule after kidney transplantation

More Information
  • 摘要:   目的  探讨肾移植术后早期应用他克莫司缓释胶囊(Tac-ER)的有效性及安全性。  方法  回顾性分析接受34对供肾所行肾移植的68例受者临床资料,接受同一供者两侧肾脏的2例受者术后分别采用Tac-ER(Tac-ER组)和他克莫司胶囊(Tac-IR)(Tac-IR组)作为基础免疫抑制药之一。比较两组他克莫司剂量及血药浓度变化、药物浓度个体内变异度(IPV)、肾功能、急性排斥反应发生率、受者和移植物存活率、不良事件发生情况。  结果  Tac-ER组的平均他克莫司日剂量高于Tac-IR组(F=8.386,P=0.005)。Tac-ER组术后4 d平均谷浓度未达目标浓度,为(6.14±4.04)ng/mL,低于Tac-IR组的(9.41±5.47)ng/mL(F=7.854,P=0.007)。Tac-ER组术后1个月内他克莫司谷浓度IPV高于Tac-IR组(0.44±0.15比0.36±0.12,P=0.032)。术后第6个月时,Tac-ER组和Tac-IR组肾功能比较差异无统计学意义[血清肌酐为(126±26)μmol/L比(120±28)μmol/L,估算肾小球滤过率为(56±13)mL/(min·1.73 m2)比(60±15)mL/(min·1.73 m2),均为P > 0.05]。两组移植物和受者存活率均为100%。Tac-ER组和Tac-IR组急性排斥反应均于术后1个月内发生,发生率分别为18%和3%,差异无统计学意义(P > 0.05)。Tac-ER组和Tac-IR组不良事件总发生率分别为94%和97%,差异无统计学意义(P > 0.05)。  结论  Tac-ER的有效性和安全性与Tac-IR相似,但需要口服更高剂量才能达到与Tac-IR相似的血药浓度。初始应用Tac-ER应在术前提前口服或以负荷剂量作为首剂量,以提高术后早期他克莫司的全身暴露量,预防暴露不足导致的急性排斥反应。

     

  • 图  1  两组受者他克莫司日剂量及谷浓度水平

    注:与Tac-IR组比较,aP < 0.05。

    Figure  1.  Daily dose and trough concentration of tacrolimus of recipients in two groups

    图  2  快代谢型受者他克莫司日剂量及谷浓度水平

    注:与Tac-IR组比较,aP < 0.05。

    Figure  2.  Daily dose and trough concentration level of tacrolimus in fast metabolizing recipients

    图  3  慢代谢型受者他克莫司日剂量及谷浓度水平

    注:与Tac-IR组比较,aP < 0.05。

    Figure  3.  Daily dose and trough concentration level of tacrolimus in slow metabolizing recipients

    图  4  两组受者血清肌酐和eGFR水平比较

    Figure  4.  Comparison of serum creatinine and eGFR levels of recipients between two groups

    表  1  两组受者他克莫司谷浓度IPV比较

    Table  1.   Comparison of the IPV of tacrolimus trough concentration in recipients between two groups (x±s)

    变量 Tac-ER组(n=34) Tac-IR组(n=34) P
    IPV
      术后1个月 0.44±0.15 0.36±0.12 0.032
      术后1~6个月 0.18±0.02 0.26±0.15 0.055
    快代谢型IPV
      术后1个月 0.43±0.15 0.32±0.10 0.015
      术后1~6个月 0.11±0.07 0.24±0.10 0.007
    慢代谢型IPV
      术后1个月 0.45±0.15 0.39±0.13 0.307
      术后1~6个月 0.19±0.08 0.27±0.15 0.190
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  • 收稿日期:  2022-10-13
  • 网络出版日期:  2023-03-15
  • 刊出日期:  2023-03-15

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