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尼可地尔对择期经皮冠状动脉介入治疗患者围手术期心肌损伤的疗效及安全性:PENMIPCI试验结果

Efficacy and safety of nicorandil on perioperative myocardial injury in patients undergoing elective percutaneous coronary intervention: results of the PENMIPCI trial.

作者信息

Ye Ziliang, Lu Haili, Su Qiang, Long Manyun, Li Lang

机构信息

Department of Cardiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China,

Department of Orthodontics, The Affiliated Dental Hospital of Guangxi Medical University, Nanning, Guangxi, People's Republic of China.

出版信息

Drug Des Devel Ther. 2018 Aug 22;12:2591-2599. doi: 10.2147/DDDT.S173931. eCollection 2018.

DOI:10.2147/DDDT.S173931
PMID:30174413
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6110631/
Abstract

BACKGROUND

Previous studies have indicated that nicorandil can reduce perioperative myocardial injury (PMI) in patients undergoing elective percutaneous coronary intervention (ePCI), but this conclusion is still controversial. Additionally, studies reporting on the safety of nicorandil are lacking. Therefore, we performed this prospective study to evaluate the efficacy and safety of nicorandil on PMI in patients undergoing ePCI.

METHODS

One hundred and forty-six patients with coronary heart disease (CHD) scheduled to undergo ePCI were randomly assigned to the nicorandil group (n=74) or control group (n=72). The primary outcomes were the change in cardiac troponin T (cTnT) and creatine kinase-MB (CK-MB) at 12 and 24 hours after surgery. The secondary outcome was the incidence of major adverse cardiac events (MACE), which was a composite of cardiac death, nonfatal myocardial infarction, new heart failure or coronary revascularization.

RESULTS

There was no difference in age (54.76±5.93 vs 56.35±5.22) between the nicorandil group and the control group. In addition, no differences were observed in the cTnT and CK-MB levels between the two groups at admission (all ⩾0.05). Compared with those in the control group, the cTnT (0.15±0.12 vs 0.12±0.10 at 12 hours and 0.17±0.12 vs 0.13±0.10 at 24 hours) and CK-MB (15.35±8.23 vs 12.31±7.93 at 12 hours and 13.63±8.87 vs 11.13±5.71 at 24 hours) levels in the nicorandil group were significantly decreased after surgery (all ⩽0.05). Furthermore, nicorandil did not increase the incidence of MACE in the nicorandil group compared with the control group (12.16% vs 12.50%).

CONCLUSIONS

Nicorandil can reduce PMI in patients undergoing ePCI and does not increase the incidence of MACE.

CLINICAL TRIAL REGISTRATION

URL: http://www.chictr.org.cn/. Unique Identifier: ChiCTR-IOR-17012056.

摘要

背景

既往研究表明,尼可地尔可降低择期经皮冠状动脉介入治疗(ePCI)患者的围手术期心肌损伤(PMI),但该结论仍存在争议。此外,关于尼可地尔安全性的研究较少。因此,我们进行了这项前瞻性研究,以评估尼可地尔对接受ePCI患者PMI的疗效和安全性。

方法

146例计划接受ePCI的冠心病(CHD)患者被随机分为尼可地尔组(n = 74)和对照组(n = 72)。主要结局指标为术后12小时和24小时心肌肌钙蛋白T(cTnT)和肌酸激酶同工酶MB(CK-MB)的变化。次要结局指标为主要不良心脏事件(MACE)的发生率,MACE为心脏死亡、非致死性心肌梗死、新发心力衰竭或冠状动脉血运重建的复合事件。

结果

尼可地尔组和对照组在年龄上无差异(54.76±5.93 vs 56.35±5.22)。此外,两组入院时cTnT和CK-MB水平也无差异(均⩾0.05)。与对照组相比,尼可地尔组术后cTnT水平(12小时:0.15±0.12 vs 0.12±0.10;24小时:0.17±0.12 vs 0.13±0.10)和CK-MB水平(12小时:15.35±8.23 vs 12.31±7.9;24小时:±8.87 vs 11.13±5.71)显著降低(均⩽0.05)。此外,与对照组相比,尼可地尔组并未增加MACE的发生率(12.16% vs 12.50%)。

结论

尼可地尔可降低接受ePCI患者的PMI,且不增加MACE的发生率。

临床试验注册

网址:http://www.chictr.org.cn/。唯一标识符:ChiCTR-IOR-17012056。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/8f19150a4ebf/dddt-12-2591Fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/3efb515e6169/dddt-12-2591Fig1.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/285194a68907/dddt-12-2591Fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/8f19150a4ebf/dddt-12-2591Fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/3efb515e6169/dddt-12-2591Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/9ffdd9fa5f5f/dddt-12-2591Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/d51c81bb869f/dddt-12-2591Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/285194a68907/dddt-12-2591Fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/6110631/8f19150a4ebf/dddt-12-2591Fig5.jpg

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