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CIRC RES:冠脉内输入自体CD34+细胞可改善STEMI后左室功能不全

2016-11-09 xing.T MedSci原创

这项临床2期、随机、双盲、安慰剂对照试验是用细胞治疗STEMI规模最大的研究,并提供了证据支持用自体细胞治疗STEMI后左室功能不全的安全性和潜在的功效。

ST段抬高型心肌梗死(STEMI)患者即使接受了直接及时的干预和治疗,但是仍存在梗死范围扩展、心力衰竭、再次心肌梗死、再次血运重建和死亡的风险。近日,Circulation Research上发表了一篇来自埃默里大学医学院埃默里临床心血管研究所Arshed A Quyyumi的研究文章,旨在探讨STEMI后左室功能不全患者冠状动脉内输入自体CD34+细胞的安全性和生物学活性。

该研究的参与者均为STEMI患者,并且成功地接受了支架治疗,而且植入支架后超过连续4天出现左室功能不全(射血分数[EF]≤48%)。研究人员收集了161例参与者的骨髓,并将参与者按1:1的比例随机进行分组,其中A组接受冠脉内输入自体CD34+细胞(最小量为10M±20%细胞;n=78),B组接受冠脉内输入稀释液(n=83)。主要安全性终点包括不良事件、严重不良事件和主要不良心脏事件。主要疗效终点包括静息状态下6个月后心肌灌注的变化水平。虽然从研究之初到之后的6个月可以观察到每个组的心肌灌注都会增加(P<0.001),但研究者发现在对照组和治疗组之间的心肌灌注情况或不良事件并不存在显著性差异。在进一步分析中,对缺血时间进行调整后,在左室射血分数和梗死面积的变化方面可以看到一个持续的良好的细胞剂量依赖效应,而且输入自体CD34+细胞的患者存活时间和不在医院的时间都较对照组要长(P=0.05)。一年内,对照组和治疗组参与者的死亡率分别为3.6%组(n=3)和0%。

这项临床2期、随机、双盲、安慰剂对照试验是用细胞治疗STEMI规模最大的研究,并提供了证据支持用自体细胞治疗STEMI后左室功能不全的安全性和潜在的功效。

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    2017-05-16 gaoxiaoe
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