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Outcomes of Early Conversion From Prograf to Generic Tacrolimus in Adult Living Donor Liver Transplant Recipients

机译:成人活体供肝移植受者从普乐他克早期转化为普他克莫司的结果

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The aim of this study was to evaluate the safety and efficacy of early conversion from the reference tacrolimus (Prograf; Astellas Pharma, Tokyo, Japan) to the generic tacrolimus (Tacrobell (R):Chong Kun Dang Pharma, Seoul, Korea) in a cohort of adult living donor liver transplant (LDLT) recipients at a single institution. Between March 2010 and May 2012, a 1:1 dose conversion was performed 2 to 4 weeks after LDLT with dose adjustments targeted to achieve trough concentrations within the therapeutic range. Tacrolimus doses and trough levels, laboratory parameters, and adverse events were assessed. A total of 149 patients were enrolled. The median transplant duration was 22 days (range; 15-28 days). During a median follow-up of 17.3 months after conversion, there were 3 episodes of acute rejection, all of which responded to high-dose steroids. No adverse events were serious enough to stop the drug. In comparison with the control group maintained on Prograf, there were no significant differences in outcomes. In conclusion, early conversion from the reference to generic tacrolimus is safe and effective in stable adult LDLT patients.
机译:这项研究的目的是评估在早期应用中从参考他克莫司(Prograf; Astellas Pharma,日本东京)到普通他克莫司(Tacrobell(R):Chong Kun Dang Pharma,韩国首尔)的早期转化的安全性和有效性。单个机构中的成年活体供体肝移植(LDLT)受者队列。在2010年3月至2012年5月之间,LDLT后2至4周进行了1:1剂量转换,并调整剂量以达到治疗范围内的谷浓度。评估他克莫司的剂量和谷值,实验室参数和不良事件。共有149名患者入组。中位移植持续时间为22天(范围:15-28天)。在转换后的中位随访期17.3个月中,发生了3次急性排斥反应,所有这些反应均对大剂量类固醇有反应。没有不良事件严重到足以停止药物的程度。与维持Prograf的对照组相比,结果没有显着差异。总之,在稳定的成年LDLT患者中,从参考早期转换为他克莫司是安全有效的。

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