注射用尼可地尔对于急性心肌梗死患者直接经皮冠状动脉介入治疗后对比剂肾病预防效果的临床研究

Efficacy of nicorandil in preventing contrast-induced nephropathy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

目的评估注射用尼可地尔对于ST段抬高型心肌梗死(STEMI)患者直接经皮冠状动脉介入治疗(PCI)后对比剂肾病的预防效果。方法本研究纳入2018年至2019年国内多家中心拟行直接PCI的STEMI患者,随机分为尼可地尔组和安慰剂组,分别在直接PCI术前静脉注射尼可地尔或安慰剂。围术期观察患者血肌酐水平的变化,研究终点为对比剂肾病的发生,定义为术后48~72 h的血肌酐相较基线血肌酐水平增加超过0.5 mg/dl或与基线血肌酐相比相对增加超过25%。结果最终研究人群纳入了行直接PCI的238例STEMI患者,其中226例(尼可地尔组和安慰剂组各113例患者)完成了围术期肾功能的检测。与安慰剂组相比,尼可地尔组最终心肌梗死溶栓治疗试验(TIMI)血流分级水平显著提高(P=0.001),并且尼可地尔组对比剂肾病的发生率明显降低(9.7%比24.8%,P=0.003)。多因素Logistic回归分析显示注射用尼可地尔与对比剂肾病的发生率降低显著相关(OR 0.379,95%CI 0.16~0.86,P=0.021)。结论尼可地尔是接受直接PCI手术的STEMI患者发生对比剂肾病的独立保护性因素。在直接PCI术前静脉注射尼可地尔可以有效预防STEMI患者术后对比剂肾病的发生。

Objective The aim of this multi-center prospective randomized controlled trial is to evaluate the efficacy of nicorandil for the prevention of contrast-induced nephropathy(CIN)after primary percutaneous coronary intervention(PCI)in patients with ST-segment elevation myocardial infarction(STEMI).Methods Patients with STEMI received primary PCI were 3enrolled,and they were randomly assigned into nicorandil group and placebo group,receiving intravenous nicorandil or placebo before primary PCI.The endpoint was the incidence of CIN,defined as an absolute increase in serum creatinine(SCr)>0.5 mg/dl or a relative increase>25%compared with baseline SCr.The secondary endpoints were major adverse cardiovascular events(MACEs)within a year.Results The final study population included 238 randomized patients,and 226 of them(n=113 for each group)monitored the perioperative renal function,and were included in the primary analysis.Compared with the placebo group,the final TIMI grade in the nicorandil group was significantly better(P=0.001),and the incidence of CIN in nicorandil group was significantly lower(9.7%vs.24.8%,P=0.003).The logistic regression analysis revealed that nicorandil was significantly associated with the decreased risk of CIN(OR 0.379,95%CI 0.16-0.86,P=0.021).Conclusions Nicorandil is an independent protective factor for CIN in STEMI patients undergoing primary PCI.Our study indicated that intravenous nicorandil could prevent CIN in patients with STEMI undergoing primary PCI.