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氢气吸入对ST段抬高型心肌梗死经皮冠状动脉介入术后不良左心室重构的影响——首例人体初步研究

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.

作者信息

Katsumata Yoshinori, Sano Fumiya, Abe Takayuki, Tamura Tomoyoshi, Fujisawa Taishi, Shiraishi Yasuyuki, Kohsaka Shun, Ueda Ikuko, Homma Koichiro, Suzuki Masaru, Okuda Shigeo, Maekawa Yuichiro, Kobayashi Eiji, Hori Shingo, Sasaki Junichi, Fukuda Keiichi, Sano Motoaki

机构信息

Department of Cardiology, Keio University School of Medicine.

Center for Molecular Hydrogen Medicine, Keio University School of Medicine.

出版信息

Circ J. 2017 Jun 23;81(7):940-947. doi: 10.1253/circj.CJ-17-0105. Epub 2017 Mar 17.

Abstract

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% Hwith 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; control: -1.4±7.2 mL/m; 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. (Clinical trials registration: UMIN00006825).

摘要

背景

在急性心肌梗死(AMI)大鼠模型中,氢气吸入(HI)可减小梗死面积并减轻左心室(LV)不良重塑。我们设计了一项针对ST段抬高型心肌梗死(STEMI)患者的前瞻性、开放标签、评估者盲法的临床试点研究。

方法与结果

20例初诊为STEMI的患者被分为HI组(含1.3%氢气和26%氧气)或对照组(26%氧气)。未发生与HI相关的严重不良事件。在全分析集里,主要经皮冠状动脉介入治疗(PCI)后7天使用心脏磁共振成像评估的心脏挽救指数,组间无显著差异(HI组:50.0±24.3%;对照组:60.1±20.1%;P=0.43)。然而,在6个月随访时的一些替代结局方面,HI组从第7天起的改善在数值上大于对照组,包括左心室每搏输出量指数(HI组:9.2±7.1 mL/m;对照组:-1.4±7.2 mL/m;P=0.03)和左心室射血分数(HI组:11.0%±9.3%;对照组:1.7%±8.3%;P=0.11)。

结论

第一项临床研究表明,PCI期间进行HI是可行且安全的,还可能促进STEMI后6个月时左心室逆向重塑。该研究未设定检验疗效的效力,因此有必要进行进一步的大规模试验。(临床试验注册号:UMIN00006825)

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