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接受他克莫司从每日两次给药转换为每日一次缓释剂型给药的肾移植受者的他克莫司剂量和血药浓度变异性

Tacrolimus dose and blood concentration variability in kidney transplant recipients undergoing conversion from twice daily to once daily modified release tacrolimus.

作者信息

Kurnatowska I, Krawczyk J, Oleksik T, Nowicki M

机构信息

Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Łódź, Łódź, Poland.

出版信息

Transplant Proc. 2011 Oct;43(8):2954-6. doi: 10.1016/j.transproceed.2011.08.021.

Abstract

INTRODUCTION

Maintenance of the target blood levels of immunosuppressive drugs is one of the main factors determining transplant function. The aim of this study was to assess the effect of the conversion of tacrolimus from twice daily (Tc) to the prolonged release form administered once daily (Tc-pr) including the variability of blood concentrations and glomerular filtration rates in kidney transplantation patients.

MATERIALS AND METHODS

This retrospective analysis evaluated 52 patients including 23 females, and 29 males with established grafts who underwent a scheduled change of treatment from Tc to Tc-pr. We examined data from six consecutive visits before and six visits after conversion.

RESULTS

The average daily dose of Tc was 3.8±2.6 mg/24 h, whereas mean coefficient of variation (CoV) calculated from the visits before conversion was 68%. After the conversion, the mean total daily dose of Tc-pr was not significantly lower (3.2±1.8 mg), as was the mean CoV at six subsequent visits 57% (P=ns). Blood concentrations in both analyzed periods remained in the target range (Tc-pr 6.7±2.9 ng/mL versus Tc-pr 5.0±1.11) with a lower CoV in the case of Tc-pr compared to Tc (22% versus 44%; P<.001). There was no difference in graft function in the analyzed periods. After conversion, lower blood glucose levels were observed: 103.4±28.3 mg/dL versus 95±25.9 mg/dL (P<.03).

CONCLUSIONS

The slow-release form of tacrolimus provided greater stability of drug blood concentrations compared with the standard form administered twice daily. The change of the tacrolimus treatment from Tc to Tc-pr dosing did not effect organ function but seemed to improve glycemic control.

摘要

引言

维持免疫抑制药物的目标血药浓度是决定移植功能的主要因素之一。本研究的目的是评估将他克莫司从每日两次给药(Tc)转换为每日一次给药的缓释剂型(Tc-pr)的效果,包括肾移植患者血药浓度和肾小球滤过率的变异性。

材料与方法

这项回顾性分析评估了52例患者,其中包括23名女性和29名男性,这些患者已接受移植且正在进行从Tc到Tc-pr的预定治疗方案变更。我们检查了转换前连续6次就诊的数据以及转换后6次就诊的数据。

结果

Tc的平均每日剂量为3.8±2.6mg/24小时,而转换前就诊计算得出的平均变异系数(CoV)为68%。转换后,Tc-pr的平均每日总剂量没有显著降低(3.2±1.8mg),随后6次就诊的平均CoV为57%(P=无显著性差异)。两个分析时间段的血药浓度均保持在目标范围内(Tc-pr为6.7±2.9ng/mL,而Tc为5.0±1.11),与Tc相比,Tc-pr的CoV较低(22%对44%;P<0.001)。分析时间段内移植功能没有差异。转换后,观察到血糖水平较低:103.4±28.3mg/dL对95±25.9mg/dL(P<0.03)。

结论

与每日两次给药的标准剂型相比,他克莫司缓释剂型可使药物血药浓度更稳定。他克莫司治疗从Tc改为Tc-pr给药并未影响器官功能,但似乎改善了血糖控制。

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