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将稳定的肾移植受者转换为长效他克莫司制剂。

Conversion to prolonged release tacrolimus formulation in stable kidney transplant recipients.

机构信息

The School of Medicine, Chung Shan Medical University, Taichung, Taiwan;

出版信息

Swiss Med Wkly. 2013 Aug 27;143:w13850. doi: 10.4414/smw.2013.13850. eCollection 2013.

Abstract

PRINCIPLES

The once-daily tacrolimus formulation (Advagraf®), with the potential for improving medical adherence, has been advocated to improve long-term kidney allograft outcomes. However, experience with late conversion from the twice-daily tacrolimus formulation (Prograf®) to Advagraf in the daily care of stable kidney transplant recipients has been limited.

METHODS

The aim of this study was to observe the efficacy and safety of conversion from Prograf to Advagraf in chronic stable kidney transplant recipients in routine clinical practice. The recruited patients had postconversion follow-up at least once monthly for a total of six months, unless they had discontinued the use of Advagraf, had been lost the follow-up or had lost the graft.

RESULTS

The mean age of the 199 patients was 51.5 ± 10.4 years (60.8% male). The mean time from transplantation to the conversion to Advagraf was 8.3 ± 3.2 years and the mean tacrolimus trough level at conversion was 4.2 ± 1.4 ng/ml. After conversion, 147 patients (73.8 %) had a reduced trough level at one month and the mean change in trough level postconversion was -13.5%. The mean serum creatinine level between conversion and six months postconversion was not significantly different (1.12 ± 0.36 vs 1.10 ± 0.42 mg/dl). Thirty-four patients (17%) discontinued the treatment with Advagraf and two (1%) developed biopsy-proved acute rejection.

CONCLUSIONS

In conclusion, frequent conversion caused by a high discontinuation rate may further raise the potential risk of allograft rejection and increase unnecessary cost. In view of this, the policy of converting to Advagraf with the purpose of improving medical adherence should be individualised in routine clinical practice.

摘要

原则

具有改善医疗依从性潜力的他克莫司每日制剂(Advagraf®),已被提倡用于改善长期肾移植的结果。然而,在日常稳定的肾移植受者的护理中,从每日两次的他克莫司制剂(Prograf®)转换为 Advagraf 的经验有限。

方法

本研究的目的是观察在常规临床实践中,将慢性稳定的肾移植受者从 Prograf 转换为 Advagraf 的疗效和安全性。招募的患者在转换后至少每月随访一次,总共随访六个月,除非他们停止使用 Advagraf、失去随访或移植肾失功。

结果

199 例患者的平均年龄为 51.5 ± 10.4 岁(60.8%为男性)。从移植到转换为 Advagraf 的平均时间为 8.3 ± 3.2 年,转换时的他克莫司谷浓度为 4.2 ± 1.4ng/ml。转换后,147 例(73.8%)患者在一个月时的谷浓度降低,转换后谷浓度的平均变化为-13.5%。转换与六个月后血清肌酐水平无显著差异(1.12 ± 0.36 vs 1.10 ± 0.42mg/dl)。34 例(17%)患者停止使用 Advagraf 治疗,2 例(1%)发生活检证实的急性排斥反应。

结论

总之,由于较高的停药率导致频繁转换可能会进一步增加移植物排斥的潜在风险,并增加不必要的成本。鉴于此,在常规临床实践中,应根据个体情况制定将患者转换为 Advagraf 以提高医疗依从性的策略。

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