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他克莫司每日一次和每日两次剂型在初发肾移植受者中的比较分析

A Comparative Analysis of Once-daily and Twice-daily Formulation of Tacrolimus in De Novo Kidney Transplant Recipients.

作者信息

Ferhatoglu Murat Ferhat, Kartal Abdulcabbar, Kivilcim Taner, Filiz Ali Ilker, Yildiz Gursel, Gurkan Alp

机构信息

Department of General Surgery, Istanbul Okan University, Faculty of Medicine, Istanbul, Turkey.

Department of Nephrology, Istanbul Okan University, Faculty of Medicine, Istanbul, Turkey.

出版信息

Sisli Etfal Hastan Tip Bul. 2021 Mar 17;55(1):62-67. doi: 10.14744/SEMB.2020.71235. eCollection 2021.

DOI:10.14744/SEMB.2020.71235
PMID:33935537
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8085452/
Abstract

OBJECTIVES

We aimed to compare the once-daily and twice-daily formulation of tacrolimus concerning the efficiency and effects on graft function in de novo kidney transplant patients.

METHODS

Twenty once-daily (TAC-OD) and twenty twice-daily (TAC-BID) tacrolimus administrated de novo kidney recipients who had received initial immunosuppressive therapy according to protocols at our institution (0.2 mg/kg of tacrolimus combined with 1000 milligrams of steroid taper plus 720 mg of mycophenolate and with 2.5mg/kg anti-thymocyte globulin) assessed concerning demographics, drug doses and blood concentration, and graft function.

RESULTS

The mean tacrolimus blood concentration measurements were higher in the TAC-OD group in the first sixty days after transplantation, and the TAC-OD group showed more blood concentration overshoots/fluctuations in the first 30 days of the treatment. The initial drug dose was significantly higher in the TAC-OD group than the TAC-BID group (p=0.04). There was no meaningful difference among groups according to graft function (creatinine measurements) (p>0.05).

CONCLUSION

Between de novo kidney recipients, the new TAC-OD formulation presents a similar short-term efficacy profile as TAC-BID. However, a higher daily dosage of TAC-OD is needed to achieve similar blood concentrations in the early postoperative period.

摘要

目的

我们旨在比较他克莫司每日一次和每日两次给药方案对初发肾移植患者移植物功能的有效性和影响。

方法

20名接受他克莫司每日一次（TAC-OD）给药和20名接受他克莫司每日两次（TAC-BID）给药的初发肾移植受者，这些患者在我们机构按照方案接受了初始免疫抑制治疗（0.2mg/kg他克莫司联合1000毫克类固醇逐渐减量加720毫克霉酚酸酯以及2.5mg/kg抗胸腺细胞球蛋白），评估了人口统计学、药物剂量和血药浓度以及移植物功能。

结果

移植后前60天，TAC-OD组的他克莫司平均血药浓度测量值更高，且TAC-OD组在治疗的前30天血药浓度超调/波动更多。TAC-OD组的初始药物剂量显著高于TAC-BID组（p = 0.04）。根据移植物功能（肌酐测量值），各组之间无显著差异（p>0.05）。

结论

在初发肾移植受者中，新的TAC-OD制剂与TAC-BID具有相似的短期疗效。然而，术后早期需要更高剂量的TAC-OD才能达到相似的血药浓度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/cd9d35b79074/MBSEH-55-62-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/7827ee277058/MBSEH-55-62-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/4003826bc2e5/MBSEH-55-62-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/846172300298/MBSEH-55-62-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/cd9d35b79074/MBSEH-55-62-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/7827ee277058/MBSEH-55-62-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/4003826bc2e5/MBSEH-55-62-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/846172300298/MBSEH-55-62-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8903/8085452/cd9d35b79074/MBSEH-55-62-g004.jpg

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