The Effects of Hydrogen Gas Inhalation on Adverse Left Ventricular Remodeling After Percutaneous Coronary Intervention for ST-Elevated Myocardial Infarction - First Pilot Study in Humans -
The Effects of Hydrogen Gas Inhalation on Adverse Left Ventricular Remodeling After Percutaneous Coronary Intervention for ST-Elevated Myocardial Infarction - First Pilot Study in Humans -
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DOI：
10.1253/circj.cj-17-0105
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发表时间：
2017-07-01
影响因子：
3.3
通讯作者：
Sano, Motoaki
中科院分区：
文献类型：
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作者：
Katsumata, Yoshinori;Sano, Fumiya;Sano, Motoaki
背景：氢气吸入(HI)可缩小急性心肌梗死(AMI)大鼠模型的心肌梗死范围，减轻不良的左心室(LV)重构。我们设计了一项针对ST段抬高心肌梗死(STEMI)患者的前瞻性、开放标签、评价者盲法临床先导研究。方法和结果：20名初步诊断为STEMI的患者被分为HI组(1.3%H-2加26%氧气)和对照组(26%氧气)。没有发生与HI相关的严重不良事件。在完全分析组中，首次经皮冠状动脉介入治疗(PCI)后第7天心脏磁共振成像评估的心脏挽救指数，组间差异无统计学意义(HI：50.0+/-24.3%；对照组：60.1+/-20.1%；P=0.43)。然而，与第7天相比，HI组在6个月随访时的某些替代结局上的改善幅度大于对照组，包括左每搏量指数(HI：9.2+/-7.1毫升/米(2)；对照组：-1.4+/-7.2毫升/米(2)；P=0.03)和左心室射血分数(HI：11.0%+/-9.3%；对照组：1.7%+/-8.3%；结论：首次临床研究表明，在STEMI后6个月，PCI术中HI是可行和安全的，并可能促进LV的反向重构。这项研究没有能力测试疗效，因此有必要进行进一步的大规模试验。
Background: Hydrogen gas inhalation (HI) reduced infarct size and mitigated adverse left ventricular (LV) remodeling in a rat model of acute myocardial infarction (AMI). We designed a prospective, open-label, rater-blinded clinical pilot study in patients experiencing ST-elevated MI (STEMI).Methods and Results: The 20 patients with an initial diagnosis of STEMI were assigned to either an HI group (1.3% H-2 with 26% oxygen) or a control group (26% oxygen). There were no HI-related severe adverse events. In the full analysis set, the cardiac salvage index as evaluated using cardiac magnetic resonance imaging at 7 days after primary percutaneous coronary intervention (PCI), showed no significant between-group difference (HI: 50.0 +/- 24.3%; control: 60.1 +/- 20.1%; P= 0.43). However, the improvement from day 7 in the HI group was numerically greater than that in the control group in some of the surrogate outcomes at 6-month follow-up, including the LV stroke volume index (HI: 9.2 +/- 7.1 mL/m(2); control: -1.4 +/- 7.2 mL/m(2); P= 0.03) and the LV ejection fraction (HI: 11.0%+/- 9.3%; control: 1.7%+/- 8.3%; P= 0.11).Conclusions: The first clinical study has shown that HI during PCI is feasible and safe and may also promote LV reverse remodeling at 6 months after STEMI. The study was not powered to test efficacy and a further large-scale trial is warranted.