Open Heart:杨跃进团队发现强化他汀联合干细胞提高射血分数达12%

2020-05-27 循环 中国循环杂志

近期,阜外医院杨跃进团队的“强化他汀提高干细胞治疗急性心肌梗死疗效的临床研究”(STEM-AMI)在BMJ子刊在线发表。

近期,阜外医院杨跃进团队的“强化他汀提高干细胞治疗急性心肌梗死疗效的临床研究”(STEM-AMI)在BMJ子刊在线发表。

近20余年来动物实验和临床研究显示干细胞治疗急性心肌梗死有效,但疗效低弱是突出难题,左心室射血分数仅提高3%~5%,严重限制了该技术的转化应用。

其关键瓶颈是干细胞移植后在梗死区的存活率和滞留率低下。针对这一突出的国际难题,杨跃进团队在国际上首创提出“他汀改良梗死心肌微环境(土壤)提高干细胞(种子)的存活率和滞留率,进而提高疗效”的假说,并通过系列临床前研究得到验证。

在此基础上于2009年~2014年开展的临床研究STEM-AMI,对该学说进行首次临床验证。

STEM-AMI研究是一项2×2析因设计、单中心、随机、双盲、安慰剂对照的临床研究。入选100例发病2~4周内、PET显示梗死区无存活心肌、左心室射血分数≤45%的广泛前壁STEMI患者。

根据他汀用药方案(常规阿托伐他汀:20 mg,qn;强化阿托伐他汀:移植前3天~后4天80 mg qn,继以20 mg,qn)和经冠脉输注的剂型[安慰剂;自体骨髓单个核细胞(MNC)],将入选患者随机分至常规阿托伐他汀+安慰剂、常规阿托伐他汀+干细胞组、强化阿托伐他汀+安慰剂组和强化阿托伐他汀+干细胞组。每组各25例。

入选患者接受SPECT/PET、MRI、UCG和BNP等血指标检测后经冠脉输注安慰剂或自体骨髓MNC。

随访1年,主要终点是左心室射血分数变化(MRI检测),次要终点是左心室大小、梗死瘢痕面积、心肌灌注/存活和心衰标志物的变化,以及复合终点事件(死亡、再发心梗、靶血管血运重建和恶性心律失常)。

共有76例患者完成终点检测,结果显示,所有接受冠脉输注干细胞的患者射血分数较安慰剂组显着增加(10.0% vs 5.0%,P=0.01)。

进一步分析发现,干细胞带来的射血分数提高仅见于强化阿托伐他汀+干细胞接种患者,射血分数提高达到了12.6%,而强化阿托伐他汀+对照组仅5.0%(P=0.001)。

常规他汀+干细胞较安慰剂也未显着提高射血分数。强化阿托伐他汀和冠脉输注干细胞存在显着的协同效应(P=0.019)。

次要终点分析发现,MRI所测干细胞组梗死瘢痕体积较安慰剂组显着减小,也仅见于强化阿托伐他汀患者。

UCG显示干细胞组EDV和ESV较安慰剂组显着减小,也仅见于强化阿托伐他汀患者,而常规阿托伐他汀患者的改变不显着。

SPECT/PET显示干细胞和安慰剂组灌注缺损面积无显着统计学差异,而反映心肌存活的FDG积分变化幅度在干细胞组显着大于安慰剂组,也只见于强化阿托伐他汀患者而非常规阿托伐他汀患者。

干细胞组NT-proBNP下降幅度显着大于安慰剂组,仅见于强化阿托伐他汀患者中。

干细胞和安慰剂组复合终点事件无显着差异,均无死亡和再发心梗。

该研究结果提示强化阿托伐他汀联合自体骨髓干细胞治疗可显着改善心功能,抑制心室重构,促进心肌再生;国际上首次在临床验证干细胞心肌再生的“土壤与种子学说”,为干细胞治疗急性心肌梗死向临床转化应用提供了坚实的临床证据。

来源:Yang YJ, Qian HY, Song L, et al. Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction. Open Heart. 2020, 7(1): e001139.

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    2021-11-12 湘雅科教

    已拜读,受益匪浅。

    0

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    2021-02-14 feather89
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    2020-05-30 独孤立克

    干细胞是热点,但是进入临床仍然需要时间和临床疗效验证哦

    0

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    2020-05-29 zhaojie88
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    2020-05-29 slcumt

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