社團法人臺灣臨床藥學會

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【原著】評估肝臟移植病人使用Tacrolimus 更換劑型的臨床療效及安全性
Evaluation of Clinical Efficacy and Safety of Switching Tacrolimus Formulation in Liver Transplant Patients
免疫抑制劑、持續釋放劑型tacrolimus、肝臟移植病人、Immunosuppressant, Once-Daily Tacrolimus, Liver Transplant Patients
王台欣Tair-Shin Wang 、魏廷聿Ting-Yu Wei 、葉子慧Tzu-Hui Yeh 、王明賢Ming-Shyan Wang 、孫淑慧*Shu-Hui Sun*
1亞東紀念醫院藥學部
目的:國外研究文獻發現,tacrolimus 持續釋放劑型可改善服藥配合度及減少副作用的發生,但本院使用持續釋放劑型並不廣泛,因此,本研究目的在於探討肝臟移植的病人,使用tacrolimus 持續釋放劑型更換前後療效及安全性的差異。
方法:本研究為觀察性研究,收入對象為門診穩定之肝臟移植病人,將tacrolimus一天兩次之劑型,更換為一天一次持續釋放劑型,所有病人追蹤6 個月,記錄藥物劑量調整、藥物血中濃度、肝腎功能的變化,同時評估服藥配合度。在療效方面收集出現急性排斥的比例,在安全性方面收集因感染而入院的比例及藥物的副作用。
結果:本研究共收入8 名肝臟移植的病人,tacrolimus 血中濃度在劑型更換前平均為4.3 ± 2.0 ng/ml,更換後第一個月血中濃度發現有顯著下降的情形 (2.3 ± 1.3ng/ml, p = 0.048),而第六個月血中濃度回升與基礎值相當。追蹤病人的肝功能,
tacrolimus 劑型更換後第一個月有些微上升但統計上無顯著差異,且追蹤期間無出現急性排斥的情形。在安全性方面,病人無發生因感染而入院的情形,且腎功能、血糖、血脂、及血壓均呈現穩定的情形。
結論:肝臟移植病人更換tacrolimus 持續釋放劑型,可維持穩定的肝腎功能,且療效及安全性相當。不過,更換劑型的第一個月,藥物血中濃度會些微下降,所以在藥物劑型更換早期需更嚴密的監測。
 
Objective: In the previous studies, conversion to tacrolimus once-daily formulation in transplant patients seemed to be effective, safe, and improving adherence. In our hospital, experience with the administration of the once-daily tacrolimus was still limited in liver transplant patients. The aim of this study was to evaluate efficacy and safety in liver transplant patients converted from twice-daily to once-daily tacrolimus.
Methods: This study was designed as an observational study in 2013. The liver transplant patients who had stable liver function and converted tacrolimus from the twice-daily to once-daily formulation were included in the study. The clinical outcomes included to evaluate tacrolimus trough level, liver and renal function, the event rate of acute rejection episodes, the event rate of infections, and the occurrence of any adverse event at pre-conversion, months 1, 3, and 6 after conversion.
Results: Eight patients were enrolled in the study. After conversion to once-daily tacrolimus, mean serum tacrolimus concentration was 4.3 ± 2.0 ng/ml at baseline, followed by a significant decline to 2.3 ± 1.3 ng/ml (p = 0.048) at month 1, and tended to equal at month 6. Liver enzymes were mildly elevated at month 1, but did not change significantly during follow-up period. There was no significant difference in renal function before conversion and at month 6 post-conversion. No rejection episodes, infections, or adverse events were occurred.
Conclusion: Conversion from twice-daily to once-daily tacrolimus in stable liver transplant patients was equivalent efficacy, adequate safety, and maintained stable liver and renal function.
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