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Am J Transplant:肾移植受者:EVR+LTac vs MMF+STac

2017-05-19 吴刚 环球医学

2017年5月,发表在《Am J Transplant》的一项由美国和加拿大科学家进行的研究比较了依维莫司+低剂量他克莫司和麦考酚酸酯+标准剂量他克莫司在从头开始肾移植受者中的有效性和安全性。

2017年5月,发表在《Am J Transplant》的一项由美国和加拿大科学家进行的研究比较了依维莫司+低剂量他克莫司和麦考酚酸酯+标准剂量他克莫司在从头开始肾移植受者中的有效性和安全性。

在这项12个月的多中心、随机、开放标签、非劣效性研究中,从头开始肾移植的受者(TRxRs)按照1:1的比例随机分配到依维莫司+低剂量他克莫司(EVR+LTac)或麦考酚酸酯+标准剂量他克莫司(MMF+STac)联合诱导治疗(巴利昔单抗或兔抗胸腺细胞球蛋白)的组中。考虑到10%的非劣效性边缘[24.6% vs 20.4%;4.2%(-3.0~11.4)],EVR+LTac vs MMF+STac的复合治疗失败率[经过治疗的经活检证实的急性排斥反应(tBPAR)/移植物丢失/死亡/失访]的非劣效性丧失了1.4%。与MMF+STac组相比,EVR+LTac组的tBPAR发生率(19.4% vs 11.2%;P<0.05)显着性高,而移植物丢失(1.3% vs 10.5%;P<0.05)和移植物丢失/死亡/失访的复合(6.1% vs 10.5%;P=0.05)的发生率显着性低。EVR+LTac组和MMF+STac组的平均估计肾小球滤过率相似[63.1(22.0)vs 63.1(19.5)mL/分/1.73m2],安全性相当。

总之,基于10%的非劣效性边缘,与MMF+STac相比,EVR+LTac丧失了非劣效性。评估改善有效性的最佳免疫抑制的进一步研究将指导合理的给药剂量和RTxRS中EVR和LTac的目标水平。

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    2018-01-20 xuyu
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    2017-07-15 grace5700
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    2017-11-02 bsmagic9140
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