尼可地尔对急性ST段抬高型心肌梗死患者介入治疗后发生对比剂诱导急性肾损伤的疗效观察
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摘要
目的探讨急性ST段抬高型心肌梗死(STEMI)患者直接经皮冠状动脉介入治疗(PPCI)术前及术后24 h内使用尼可地尔对对比剂诱导的急性肾损伤(CI-AKI)发病率的影响。方法采用前瞻性单盲随机对照设计,纳入行PPCI的STEMI患者397例。随机分为尼可地尔组(n=199)和对照组(n=198)。主要观察指标为术后CI-AKI的发病率,次要观察指标为术后住院期间主要不良心血管事件(MACE)及需要肾脏替代治疗等情况。结果 STEMI患者心肌总缺血时间为(6.1±2.1) h。尼可地尔组、对照组术前Mehran风险评分差异无统计学意义(P>0.05)。术后采血时间的中位数为28.5(25.3,29.6)h,397例患者中53例(13.4%)发生CI-AKI,其中尼可地尔组17例(8.5%)、对照组36例(18.2%)(P<0.05)。多因素Logistic回归分析显示,与对照组比较,尼可地尔可以降低术后血肌酐(SCr)增幅或血肌酐差值(ΔSCr)(OR=0.38,95%CI 0.20～0.72,P=0.003),提示其可能为术后发生CI-AKI的独立保护因素;碘对比剂(CM)剂量(OR=1.03,95%CI 1.01～1.04,P<0.001)是发生CI-AKI的独立危险因素。尼可地尔组术后24 h内心绞痛发生率更低(P<0.05),其他MACE及需要肾脏替代治疗事件方面,两组之间差异无显著性(P>0.05)。结论 STEMI患者PPCI术前及术后24 h内使用尼可地尔,可以预防CI-AKI的发生,但并不改善短期预后。
Aim To investigate the effect of continuous intravenous injection of nicorandil on the incidence of contrast-induced acute kidney injury(CI-AKI) in patients with acute ST-segment elevation myocardial infarction(STEMI) undergoing primary percutaneous coronary intervention(PPCI). Methods A total of 397 patients with STEMI undergoing PPCI were enrolled in this prospective randomized controlled trial. Patients were randomly assigned into two groups: the nicorandil group(n=199)and the control group(n=198). The primary outcome was the incidence of CI-AKI, the secondary outcomes included the major adverse cardiovascular events(MACE) during hospitalization and the need of renal replacement therapy. Results The average of myocardial ischemia was(6.1±2.1) hours. No significant difference was observed in Mehran score and other baseline characteristics between groups(P>0.05). The median duration of blood sampling time after operation was 28.5(25.3,29.6)hours. As a result, there were 53(13.4%) out of 397 patients suffered from CI-AKI, 17(8.5%) in the nicorandil group and 36(18.2%) in the control group, respectively(P<0.05). In the multivariate Logistic regression model, nicorandil acted as an independent protective factor of CI-AKI(OR=0.38, 95% CI 0.20～0.72, P=0.003). Whereas, the volume of CM(OR=1.03, 95% CI 1.01～1.04, P<0.001)was an independent risk factor for CI-AKI. The incidence of angina within 24 hours post PPCIin control group was higher than that in nicorandil group(P<0.05). There was no significant difference in MACE, and renal replacement therapy between the two groups(P>0.05). Conclusion Intravenous injection of nicorandil perioperatively can reduce the incidence of CI-AKI in STEMI patients undergoing PPCI, but does not improve the short-term prognosis.
Aim To investigate the effect of continuous intravenous injection of nicorandil on the incidence of contrast-induced acute kidney injury(CI-AKI) in patients with acute ST-segment elevation myocardial infarction(STEMI) undergoing primary percutaneous coronary intervention(PPCI). Methods A total of 397 patients with STEMI undergoing PPCI were enrolled in this prospective randomized controlled trial. Patients were randomly assigned into two groups: the nicorandil group(n=199)and the control group(n=198). The primary outcome was the incidence of CI-AKI, the secondary outcomes included the major adverse cardiovascular events(MACE) during hospitalization and the need of renal replacement therapy. Results The average of myocardial ischemia was(6.1±2.1) hours. No significant difference was observed in Mehran score and other baseline characteristics between groups(P>0.05). The median duration of blood sampling time after operation was 28.5(25.3,29.6)hours. As a result, there were 53(13.4%) out of 397 patients suffered from CI-AKI, 17(8.5%) in the nicorandil group and 36(18.2%) in the control group, respectively(P<0.05). In the multivariate Logistic regression model, nicorandil acted as an independent protective factor of CI-AKI(OR=0.38, 95% CI 0.20～0.72, P=0.003). Whereas, the volume of CM(OR=1.03, 95% CI 1.01～1.04, P<0.001)was an independent risk factor for CI-AKI. The incidence of angina within 24 hours post PPCIin control group was higher than that in nicorandil group(P<0.05). There was no significant difference in MACE, and renal replacement therapy between the two groups(P>0.05). Conclusion Intravenous injection of nicorandil perioperatively can reduce the incidence of CI-AKI in STEMI patients undergoing PPCI, but does not improve the short-term prognosis.
引文
[1]Alejandro RM,Marinela C,Belén P,et al.The reno-protective effect of hydration with sodium bicarbonate plus n-acetylcysteine in patients undergoing emergency percutaneous coronary intervention:the RENO study[J].J Am Coll Cardiol,2007,49(12):1283-1288.
[2]Mccullough PA.Contrast-induced acute kidney injury[J].JAm Coll Cardiol,2016,68(13):1465-1473.
[3]Mehran R,Aymong ED,Nikolsky E,et al.A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention:development and initial validation[J].J Am Coll Cardiol,2004,44(7):1393-1399.
[4]Liu CW,Liao PC,Chen KC,et al.SYNTAX score of infarct-related artery otherthan the number of coronary balloon inflations and deflations as an independent predictor of contrast-induced acute kidney injury in patients with ST-Segment elevation myocardial infarction[J].Acta Cardiol Sin,2017,33(4):362-376.
[5]Marenzi G,Assanelli E,Campodonico J,et al.Contrast volume during primary percutaneous coronary intervention and subsequent contrast-induced nephropathy and mortality[J].Ann Intern Med,2009,150(3):170-177.
[6]Shimizu S,Saito M,Kinoshita Y,et al.Nicorandil ameliorates ischaemia-reperfusion injury in the rat kidney[J].Br J Pharmacol,2011,163(2):272-282.
[7]Sun Z,Zhang X,Ito K,et al.Amelioration of oxidative mitochondrial DNA damage and deletion after renal ischemic injury by the KATP channel opener diazoxide[J].Am JPhysiol Renal Physiol,2008,294(3):F491-F498.
[8]Nawa T,Nishigaki K,Kinomura Y,et al.Continuous intravenous infusion of nicorandil for 4 hours before and 24hours after percutaneous coronary intervention protects against contrast-induced nephropathy in patients with poor renal function[J].Int J Cardiol,2015,195(5):228-234.
[9]Iranirad L,Hejazi SF,Sadeghi MS,et al.Efficacy of nicorandil treatment for prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization:a prospective randomized controlled trial[J].Cardiol J,2017,24(5):502-507.
[10]Fan Y,Wei Q,Cai J,et al.Preventive effect of oral nicorandil on contrast-induced nephropathy in patients with renal insufficiency undergoing elective cardiac catheterization[J].Heart Vessels,2016,31(11):1776-1782.
[11]Ko YG,Lee BK,Kang WC,et al.Preventive effect ofpretreatment with intravenous nicorandil on contrastinduced nephropathy in patients with renal dysfunction undergoing coronary angiography(PRINCIPLE Study)[J].Yonsei Med J,2013,54(4):957-964.
[12]Silver SA,Shah PM,Chertow GM,et al.Risk prediction models for contrast induced nephropathy:systematic review[J].BMJ,2015,351:1-9.
[13]陈伟伟,高润霖,刘力生,等.《中国心血管病报告2017》概要[J].中国循环杂志,2018,33(1):1-8.
[14]Pisani A,Riccio E,Andreucci M,et al.Role of reactive oxygen species in pathogenesis of radiocontrast-induced nephropathy[J].Biomed Res Int,2013,2013(4):1-6.
[15]稂与恒,李彤,崔晓琼,等.非酒精性脂肪肝与急诊PCI术后对比剂肾病的相关性[J].中国动脉硬化杂志,2018,26(9):936-940.
[16]范继红,胡桃红,贺威,等.肾功能正常或轻度损害的急性冠状动脉综合征患者经皮冠状动脉介入治疗术后发生对比剂肾病的危险因素分析[J].中国循环杂志,2016,31(1):31-35.
[17]Fox CS,Muntner P,Chen AY,et a1.Short-term outcomes of acute myocardialinfarctionin patients withacute kidneyinjury:areportfrom the national cardiovasculardata registry[J].Circulation,2012,125(3):497-504.
[18]Nijssen EC,Rennenberg RJ,Nelemans PJ,et al.Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy(AMACING):a prospective,randomised,phase 3,controlled,open-label,non-inferiority trial[J].Lancet,2017,389(10076):1312-1322.
[19]Laville M,Juillard L.Contrast-induced acute kidney injury:how should at-risk patients be identified and managed?[J].J Nephrol,2010,23(4):387-398.
[20]王志清,陈梅贤,刘东林,等.预防性冠状动脉内注射尼可地尔对急性ST段抬高型心肌梗死介入治疗后心肌血流灌注及预后的影响[J].中华心血管病杂志,2017,45(1):26-33.
[21]Serizawa K,Yogo K,Tashiro Y,et al.Nicorandil ameliorated hypertensive renal Injury without lowering blood pressure in spontaneously hypertensive rats[J].Pharmacology,2013,91(2):92-103.
[22]Lei R,Zhao F,Tang CY,et al.Mitophagy plays a protective role in iodinated contrast-induced acute renal tubular epithelial cells injury[J].Cell Physiol Biochem,2018,46(3):975-985.
[2]Mccullough PA.Contrast-induced acute kidney injury[J].JAm Coll Cardiol,2016,68(13):1465-1473.
[3]Mehran R,Aymong ED,Nikolsky E,et al.A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention:development and initial validation[J].J Am Coll Cardiol,2004,44(7):1393-1399.
[4]Liu CW,Liao PC,Chen KC,et al.SYNTAX score of infarct-related artery otherthan the number of coronary balloon inflations and deflations as an independent predictor of contrast-induced acute kidney injury in patients with ST-Segment elevation myocardial infarction[J].Acta Cardiol Sin,2017,33(4):362-376.
[5]Marenzi G,Assanelli E,Campodonico J,et al.Contrast volume during primary percutaneous coronary intervention and subsequent contrast-induced nephropathy and mortality[J].Ann Intern Med,2009,150(3):170-177.
[6]Shimizu S,Saito M,Kinoshita Y,et al.Nicorandil ameliorates ischaemia-reperfusion injury in the rat kidney[J].Br J Pharmacol,2011,163(2):272-282.
[7]Sun Z,Zhang X,Ito K,et al.Amelioration of oxidative mitochondrial DNA damage and deletion after renal ischemic injury by the KATP channel opener diazoxide[J].Am JPhysiol Renal Physiol,2008,294(3):F491-F498.
[8]Nawa T,Nishigaki K,Kinomura Y,et al.Continuous intravenous infusion of nicorandil for 4 hours before and 24hours after percutaneous coronary intervention protects against contrast-induced nephropathy in patients with poor renal function[J].Int J Cardiol,2015,195(5):228-234.
[9]Iranirad L,Hejazi SF,Sadeghi MS,et al.Efficacy of nicorandil treatment for prevention of contrast-induced nephropathy in high-risk patients undergoing cardiac catheterization:a prospective randomized controlled trial[J].Cardiol J,2017,24(5):502-507.
[10]Fan Y,Wei Q,Cai J,et al.Preventive effect of oral nicorandil on contrast-induced nephropathy in patients with renal insufficiency undergoing elective cardiac catheterization[J].Heart Vessels,2016,31(11):1776-1782.
[11]Ko YG,Lee BK,Kang WC,et al.Preventive effect ofpretreatment with intravenous nicorandil on contrastinduced nephropathy in patients with renal dysfunction undergoing coronary angiography(PRINCIPLE Study)[J].Yonsei Med J,2013,54(4):957-964.
[12]Silver SA,Shah PM,Chertow GM,et al.Risk prediction models for contrast induced nephropathy:systematic review[J].BMJ,2015,351:1-9.
[13]陈伟伟,高润霖,刘力生,等.《中国心血管病报告2017》概要[J].中国循环杂志,2018,33(1):1-8.
[14]Pisani A,Riccio E,Andreucci M,et al.Role of reactive oxygen species in pathogenesis of radiocontrast-induced nephropathy[J].Biomed Res Int,2013,2013(4):1-6.
[15]稂与恒,李彤,崔晓琼,等.非酒精性脂肪肝与急诊PCI术后对比剂肾病的相关性[J].中国动脉硬化杂志,2018,26(9):936-940.
[16]范继红,胡桃红,贺威,等.肾功能正常或轻度损害的急性冠状动脉综合征患者经皮冠状动脉介入治疗术后发生对比剂肾病的危险因素分析[J].中国循环杂志,2016,31(1):31-35.
[17]Fox CS,Muntner P,Chen AY,et a1.Short-term outcomes of acute myocardialinfarctionin patients withacute kidneyinjury:areportfrom the national cardiovasculardata registry[J].Circulation,2012,125(3):497-504.
[18]Nijssen EC,Rennenberg RJ,Nelemans PJ,et al.Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy(AMACING):a prospective,randomised,phase 3,controlled,open-label,non-inferiority trial[J].Lancet,2017,389(10076):1312-1322.
[19]Laville M,Juillard L.Contrast-induced acute kidney injury:how should at-risk patients be identified and managed?[J].J Nephrol,2010,23(4):387-398.
[20]王志清,陈梅贤,刘东林,等.预防性冠状动脉内注射尼可地尔对急性ST段抬高型心肌梗死介入治疗后心肌血流灌注及预后的影响[J].中华心血管病杂志,2017,45(1):26-33.
[21]Serizawa K,Yogo K,Tashiro Y,et al.Nicorandil ameliorated hypertensive renal Injury without lowering blood pressure in spontaneously hypertensive rats[J].Pharmacology,2013,91(2):92-103.
[22]Lei R,Zhao F,Tang CY,et al.Mitophagy plays a protective role in iodinated contrast-induced acute renal tubular epithelial cells injury[J].Cell Physiol Biochem,2018,46(3):975-985.