Three-Month Experience With Tacrolimus Once-Daily Regimen in Stable Renal Allografts
Three-Month Experience With Tacrolimus Once-Daily Regimen in Stable Renal Allografts
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DOI：
10.1016/j.transproceed.2009.06.048
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发表时间：
2009-07-01
影响因子：
0.9
通讯作者：
Gomez Huertas, E.
中科院分区：
文献类型：
--
作者：
Diez Ojea, B.;Alonso Alvarez, M.;Gomez Huertas, E.
导论. MR-4是他克莫司的新口服制剂，允许每日一次给药，可能会改善患者的依从性。本研究的目的是评估一组稳定的移植肾转MR-4后的安全性和有效性参数。我们招募了82名稳定的肾移植受者，他们在43.9 +/- 38.3个月前接受了移植。他们的平均年龄为56 - 12岁，包括70.7%的男性。66例患者从每日总剂量中按毫克转换;其余患者由医生酌情转换。3例患者被排除：1例因腹痛，2例因给药错误。在入组时和第7、30和90天评价他克莫司谷浓度和肾功能检查。仅5例（7.6%）转换患者需要后期剂量调整。在61例不需要调整的患者中，他克莫司平均谷浓度在第一周内下降（6.8 +/- 1.7至5.8 +/- 2.0; P < .000）。38例患者完成了3个月的随访。他们的他克莫司谷浓度、血清肌酐水平和蛋白尿保持稳定。转换为MR-4后，每例患者所需的胶囊数量较低（3.9 +/- 1.6 vs 2.9 +/- 1.0; P <0.000）。无急性排斥反应发生。根据毫克对毫克的转换，只有7.6%的患者需要调整剂量。随着这种转换，在第7天记录到他克莫司谷浓度的初始降低，其保持稳定至研究结束。患者需要的胶囊数量较少。这些结果支持MR-4的安全性。
Introduction. MR-4, the new oral formulation of tacrolimus that allows once-daily dosing, may improve patient compliance. The purpose of this study was to evaluate the safety and efficacy parameters among a group of stable renal allografts after conversion to MR-4.Methods. We enrolled 82 stable kidney recipients, who had received their grafts 43.9 +/- 38.3 months prior. They were of mean age 56 12 years and included 70.7% men. Sixty-six patients were converted on a milligram-for-milligram basis from their total daily dose; the remaining patients were converted at the physician's discretion. Three patients were excluded: 1 because of the development of abdominal pain, and 2 because of dosing errors. Tacrolimus trough levels and renal function tests were evaluated at entry and on days 7, 30, and 90.Results. Only 5 (7.6%) converted patients required a later dose adjustment. In the group of 61 patients who did not require this adjustment, the mean tacrolimus trough levels decreased during the first week (6.8 +/- 1.7 to 5.8 +/- 2.0; P < .000). Thirty-eight patients completed 3 months of follow-up. Their tacrolimus trough levels, serum creatinine levels, and proteinuria remained stable. The number of capsules per patient needed after the conversion to MR-4 was lower (3.9 +/- 1.6 versus 2.9 +/- 1.0; P < .000). There were no cases of acute rejection episodes.Conclusion. Based on a milligram-for-milligram conversion, only 7.6% of our patients required a dose adjustment. With this conversion, an initial decrease in tacrolimus trough levels was documented at day 7, which remained stable to the end of the study. The patients needed a lower number of capsules. These results supported the safety of MR-4.