摘要目的 探讨缺血后处理(IPC)对急性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)后心肾损伤的作用.方法 本试验为前瞻性、随机、对照、单盲、临床注册研究,连续入选2012年1月至2014年6月在天津市第三中心医院心脏中心住院并行PPCI的STEMI患者251例.采用随机数字表法,将STEMI患者分为处理组(123例)和对照组(128例).处理组先行IPC(在梗死相关动脉开通后1 min内,使用球囊导管低压力充气-放气3次),然后行介入治疗;对照组直接行PPCI.分析两组的基本临床资料、术中再灌注心律失常发生率、术后心电图ST段回落率、心肌坏死标志物峰值、对比剂急性肾功能损害和1年内主要不良心血管事件(包括再次急性心肌梗死、恶性心律失常、因心力衰竭而再次住院、再次血运重建、卒中和死亡)发生率.结果 处理组和对照组患者的年龄分别为(61.2±12.6)岁和(64.2±12.1)岁(P =0.768).处理组术中再灌注心律失常发生率低于对照组[42.28％ (52/123)比57.03％(73/128),P=0.023].处理组术后即刻心电图ST回落率高于对照组[77.24％(95/123)比64.84％(83/128),P=0.037].处理组术后心肌坏死标志物峰值均低于对照组[肌酸激酶:1 257(682,2 202) U/L比1 737(794,2 816) U/L,P=0.029;肌酸激酶同工酶(CK-MB):123(75,218)U/L比165(95,288) U/L,P=0.010].处理组术后对比剂急性肾功能损害发生率低于对照组[5.69％(7/123)比14.06％(18/128),P=0.034].处理组术后1年的主要不良心血管事件发生率低于对照组[7.32％(9/123)比15.63％ (20/128),P=0.040].结论 STEMI患者在PPCI术中采用IPC技术可减轻心肌缺血再灌注损伤,降低术后对比剂肾病和1年内主要不良心血管事件发生率,对心脏和肾脏均有保护作用.临床试验注册 中国临床试验注册中心,注册号为ChiCTR-ICR-15006590.

abstractsObjective To evaluate the effect of the ischemic post-conditioning (IPC) on the prevention of the cardio-renal damage in patients with acute ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PPCI).Methods A total of 251 consecutive STEMI patients underwent PPCI in the heart center of Tianjin Third Central Hospital from January 2012 to June 2014 were enrolled in this prospective,randomized,control,single-blinded,clinical registry study.Patients were randomly divided into IPC group (123 cases) and control group (128 cases) with random number table.Patients in IPC group underwent three times of inflation/deflation with low inflation pressure using a balloon catheter within one minute after culprit vessel blood recovery,and then treated by PPCI.Patients in control group received PPCI procedure directly.The basic clinical characteristics,incidence of reperfusion arrhythmia during the procedure,the rate of electrocardiogram ST-segment decline,peak value of myocardial necrosis markers,incidence of contrast induced acute kidney injury (CI-AKI),and one-year major adverse cardiovascular events (MACE) which including myocardial infarction again,malignant arrhythmia,rehospitalization for heart failure,repeat revascularization,stroke,and death after the procedure were analyzed between the two groups.Results The age of IPC group and control group were comparable ((61.2 ± 12.6) vs.(64.2 ± 12.1) years old,P =0.768).The incidence of reperfusion arrhythmia during the procedure was significantly lower in the IPC group than in the control group(42.28％ (52/123) vs.57.03％ (73/128),P =0.023).The rate of electrocardiogram ST-segment decline immediately after the procedure was significantly higher in the IPC group than in the control group (77.24％ (95/123) vs.64.84％ (83/128),P =0.037).The peak value of myocardial necrosis markers after the procedure were significantly lower in the IPC group than in the control group (creatine kinase:1 257 (682,2 202) U/L vs.1 737(794,2 816) U/L,P =0.029;ereatine kinase-MB:123 (75,218) U/L vs.165 (95,288) U/L,P =0.010).The rate of CI-AKI after the procedure was significantly lower in the IPC group than in the control group(5.69％ (7/123) vs.14.06％ (18/128),P=0.034).The rate of the one-year MACE was significantly lower in the IPC group than in the control group(7.32％ (9/123) vs.15.63％ (20/128),P =0.040).Conclusion The IPC strategy performed eight before PPCI can reduce myocardial ischemia-reperfusion injury,decline the rates of CI-AKI and one-year MACE significantly in STEMI patients,thus has a significant protective effect on heart and kidney in STEMI patients.Clinical Trial Registration Chinese Clinical Trials Registry,ChiCTR-ICR-15006590.