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他克莫司每日一次剂型:血浆水平、移植物功能及心血管危险因素的监测。

Once daily tacrolimus formulation: monitoring of plasma levels, graft function, and cardiovascular risk factors.

作者信息

Meçule A, Poli L, Nofroni I, Bachetoni A, Tinti F, Umbro I, Barile M, Berloco P B, Mitterhofer A P

机构信息

DAI Nefro-Urologico, Specialità Chirurgiche e Trapianti d'Organo Paride Stefanini, Roma, Italy.

出版信息

Transplant Proc. 2010 May;42(4):1317-9. doi: 10.1016/j.transproceed.2010.03.123.

DOI:10.1016/j.transproceed.2010.03.123
PMID:20534290
Abstract

BACKGROUND

Advagraf, an extended release formulation of tacrolimus, is administered once daily during the morning fast. Tacrolimus can be safely converted from the twice daily formulation (Prograf) to the same dose (1 mg:1 mg) of once daily dosing tacrolimus (m-Tac). The adverse effects of tacrolimus play important roles in posttransplant cardiovascular risk factors (CVR): hyperglycemia, posttransplant diabetes mellitus, dyslipidemia and hypertension. It has been suggested that avoiding high tacrolimus peak levels minimizes its diabetogenic effects leading to better glycemic control. The aim of our study was to observe the effects of conversion to m-Tac therapy on graft function and CVR among stable transplant kidney recipients.

METHODS

We selected 2 groups of 20 patients with stable kidney transplantation, who had been treated with Prograf for >6 months with a triple regimen. Group 1 were converted to once daily tacrolimus at the same dose (1 mg:1 mg); whereas in group 2, the therapy was maintained as a twice daily regimen. Blood pressure, creatinine and glomerular filtration rate levels evaluated by the Modification of Diet in Renal Disease formula, as well as urea, total, high- and low-density lipoprotein remained stable between the 2 groups as well as inside group 1 before and after conversion.

RESULTS

After conversion, glycemia and triglyceride values showed significant reductions in group 1 and between the 2 groups. These results were significant, as they may be associated with better long-term graft and patient survivals.

摘要

背景

他克莫司缓释制剂Advagraf需在早晨禁食期间每日服用一次。他克莫司可从每日两次给药制剂(普乐可复)安全转换为相同剂量(1毫克:1毫克)的每日一次给药他克莫司(m-Tac)。他克莫司的不良反应在移植后心血管危险因素(CVR)中起重要作用,包括高血糖、移植后糖尿病、血脂异常和高血压。有人提出,避免他克莫司出现高血药峰浓度可将其致糖尿病作用降至最低,从而实现更好的血糖控制。我们研究的目的是观察转换为m-Tac治疗对稳定的肾移植受者移植肾功能和CVR的影响。

方法

我们选择了两组各20例稳定肾移植患者,他们接受普乐可复三联疗法治疗超过6个月。第1组转换为相同剂量(1毫克:1毫克)的每日一次他克莫司治疗;而第2组维持每日两次给药方案。通过肾病饮食改良公式评估的血压、肌酐和肾小球滤过率水平,以及尿素、总胆固醇、高密度脂蛋白和低密度脂蛋白在两组之间以及第1组转换前后均保持稳定。

结果

转换后,第1组以及两组之间的血糖和甘油三酯值均显著降低。这些结果很显著,因为它们可能与更好的长期移植肾存活和患者存活相关。

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