移植前药代动力学分析和移植后他克莫司的需求。

Pre-transplant pharmacokinetic profiling and tacrolimus requirements post-transplant.

机构信息

Department of Renal Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia.

出版信息

Nephrology (Carlton). 2010 Oct;15(7):714-9. doi: 10.1111/j.1440-1797.2010.01351.x.

DOI:10.1111/j.1440-1797.2010.01351.x

PMID:21040167

Abstract

AIM

To determine the proportion of patients achieving tacrolimus whole-blood concentrations of ≥10 ng/mL within 3 days of kidney transplantation, after randomization either to standard dosing (control group) or post-transplantation dosing guided by a 2-hour (C(2) ) level following a preoperative tacrolimus dose (T2 group).

METHODS

The first postoperative tacrolimus dose was given either according to standard care (control group) or 0.15 mg/kg b.d. if the pre-transplant C(2) level was ≤20 ng/mL, 0.1 mg/kg b.d. if the C(2) level was 21-59 ng/mL or 0.05 mg/kg b.d. if the C(2) level was ≥60 ng/mL (T2 group). Subsequent dosing in both groups was based upon tacrolimus trough level monitoring. Participants received concomitant mycophenolate mofetil and steroids.

RESULTS

Ninety patients were recruited, of which 84 were included in the analysis (control group n=43; T2 group n=41). There was no difference in the proportion of subjects achieving tacrolimus trough levels ≥10 ng/mL (82.9% Control vs 93.0% T2; P=0.19) or between 10 and 15 ng/mL (41.5% Control vs 41.9% T2; P=0.97) at day 3 post transplant. The T2 group achieved tacrolimus trough levels of ≥10 ng/mL significantly faster than the control group (100% achievement in 14 days (Control) versus 4 days (T2); P=0.01).

CONCLUSION

Performing a pre-transplant tacrolimus C(2) does not significantly increase the high proportion of subjects achieving 10 ng/mL tacrolimus concentrations by day 3 using routine protocols. However, compared with standard care, performing a pre-transplant tacrolimus C(2) does lead to patients achieving a whole-blood concentration of ≥10 ng/mL sooner.

摘要

目的

确定肾移植后 3 天内，随机分为标准剂量组（对照组）或术后根据 2 小时浓度（C2）调整剂量组（T2 组）后，患者血中环孢素浓度达到≥10ng/ml 的比例。

方法

术后首次给予环孢素剂量，标准剂量组（对照组）给予常规剂量，T2 组根据术前 C2 水平调整剂量，C2 水平≤20ng/ml 时给予 0.15mg/kg，b.d.；C2 水平为 21-59ng/ml 时给予 0.1mg/kg，b.d.；C2 水平≥60ng/ml 时给予 0.05mg/kg，b.d.。两组后续剂量均根据环孢素谷浓度监测结果调整。所有患者均接受吗替麦考酚酯和皮质类固醇治疗。

结果

共纳入 90 例患者，其中 84 例纳入分析（对照组 43 例，T2 组 41 例）。T2 组达到环孢素谷浓度≥10ng/ml 的患者比例（82.9% 对照组 vs 93.0% T2；P=0.19）和达到 10-15ng/ml 的患者比例（41.5% 对照组 vs 41.9% T2；P=0.97）均无显著差异。T2 组达到环孢素谷浓度≥10ng/ml 的速度显著快于对照组（对照组 100%在 14 天内，T2 组为 4 天；P=0.01）。