| Background:In the past 20 years,the incidence of acute ST-elevation myocardial infarction(STEMI)has been on the rise in China.The number of deaths caused by STEMI and the prevalence of ischemic heart failure have been on the rise.Percutaneous coronary intervention(PCI),which can effectively recanalize obstructed vessels,has become the primary treatment for STEMI.Related studies have shown that myocardial infarction area of STEMI one month after PCI is closely related to the 1-year mortality rate and the incidence of heart failure,thus the size of myocardial infarction area is commonly used to evaluate the efficacy of reperfusion in clinical trials.Although timely reperfusion is the most effective method to reduce the myocardial infarction area,the instantaneous perfusion of blood flow itself can cause the death of myocardial cells and the blockage of coronary microvessels,which resulting myocardial infarction area can occupy 50% of the total myocardial infarction area.Reperfusion injury greatly weakens the therapeutic effect.Effective measures should be found to reduce the area of myocardial infarction and improve coronary microvascular function caused by reperfusion injury.Previous researches have suggested that the use of intravenous injection beta-blockers(metoprolol,esmolol)in early STEMI can reduce myocardial infarction area and improve left ventricular ejection fraction,and improve microcirculation function.However,there are few clinical studies supporting it in recent years.Esmolol hydrochloride is an ultra-short-acting,highly selective type of beta-blocker that blocks receptors by competing for catecholamine binding sites.The distribution halflife and clearance half-life were both short,2min and 9min,respectively.It is the purpose of this study to evaluate the safety and efficacy of intravenous administration of medium-and low-dose esmolol hydrochloride for improving the prognosis of STEMI during PCI.Methods:The trial was a prospective,open,randomized controlled,single-blind,optimal design trial.Patients were selected who were admitted to the emergency department of cardiology of tangdu hospital from August 2018 to February 2019 and diagnosed with STEMI.All patients received the treatment recommended by the current STEMI guidelines.The trial group received esmolol hydrochloride as an intervention and the control group receiving saline as a placebo.After diagnosis of STEMI in the emergency department,patients without contraindications were immediately given a loading dose of dual antiplatelet(aspirin,clopidogrel,or tigrello),preoperatively treated with heparin 70 IU/kg,and PCI were completed according to the guidelines.The loading dose of 0.5mg/kg esserol hydrochloride was given intravenously(within 1min),followed by a maintenance dose of 0.05 or0.1mg/kg/min esserol hydrochloride micropump,which continued until the end of PCI just before the angiography beginning.After emergency PCI,patients were given subcutaneous injection of low molecular weight heparin(LMWH)for 3-5 days,daily oral administration of the platelet drug aspirin,clopidogrel or tigrel,and oral administration of drugs such as statins,beta-blockers,ACEI or angiotensin II receptor antagonist(ARB),based on the patient’s laboratory examination results and vital signs.We will adjust the medication and treatment according to recovery of patients.ECG,myocardial infarction markers [ck-mb,amino-terminal brain natriuretic peptide precursors(nt-pro-bnp,c Tn I)],blood biochemistry,liver and kidney function,blood lipid,blood glucose and other tests should be completed for all patients after admission,and UCG should be reexamined 3d after surgery.ECG and myocardial infarction markers were reexamined at 90 min and 24 h after the operation(ckmb,ntpro-bnp,c Tn I),respectly.UCG was reexamined at 6 weeks,12 weeks and 24 weeks after the operation.In this study,the primary observation end point was the myocardial infarction markers 24 hours after surgery and the secondary observation end point was the changes of electrocardiogram ST segment,the results of UCG at 3d,6 weeks,12 weeks and24 weeks,the SAQ score and the MACE at 6 months.The safe end point was the incidence of intraoperative arrhythmia and cardiogenic shock.The above data were analyzed by t test,X2 test and non-parametric rank sum test.Results:1.Baseline data comparison: There were 140 patients with STEMI,excluding recanalization time > 12 hours,age > 80 years old,and a history of coronary heart disease,acute myocardial infarction(ami)or had a long history,beta-blockers medicine imaging results show that the variant angina pectoris.Total 117 patients were included in the study.There were no statistically significant differences in age,gender composition,body mass index(BMI),blood pressure,Killip grade,estimated glomerular filtration rate(e GFR),major co-existing diseases(diabetes,hypertension,hyperlipidemia),smoking rate,blood glucose,blood lipid,c Tn I,ck-mb,nt-pro-bnp,etc.,between the two groups.2.Primary end point: In this study,compared with the control group after,trial had lower average 9.94 ng/ml(30%)in c Tn I and the difference between the two groups have statistical significance(P < 0.05).CK – MB have redused average 17.21 ng/ml(31%)and the difference between the two groups have statistical significance(P < 0.05).The results show that the use of intravenous injection esmolol hydrochloric can reduce myocardial injury compared with the control group.3.The average heart rate in trial group is lower compared with the control about 8times/min.The incidence of ventricular arrhythmia have fallen 19% in the trial group and the difference was statistically significant.The trial group did not increase the risk of sinus bradycardia and cardiac shock.The use of intrabenous injection esmolol can effectively reduce the occurrence of ventricular arrhythmia which was proved to be safe.The number of patients with a decrease of > 50% in the ST segment at 90 min after the operation in the trial group was more than that in the control group,with a statistically significant difference(P < 0.01).The results showed that intravenous use esmolol during PCI can improve myocardial ischemia.The difference of UCG results between the two groups at 12 and 24 weeks after surgery was statistically significant(P < 0.05,P < 0.01),and the trial group was significantly better than the control group.The total incidence of MACE events was 18%(10/55)in the trial group 6 momths later,and 20%(11/55)in the control group,which is no significant difference between the two groups.SAQ score after 6 months showed that angina pectoris attack frequency was lower and the state was more stable in the trial group.4.According to the result of the regression analysis of influencing factors,it can be concluded that medication at the age of 38-55 has a significant effect on patients than <38.When the SBT is more than 6.5 hours,the help of medication will be more efficient.Conclusion:Intravenous administration low doses of esmolol can reduce the myocardial injury in patients with STEMI,alleviate myocardial ischemia,reduce the incidence of intraoperative ventricular arrhythmia,improve LVEF at 24 weeks,reduce postoperative frequency of angina pectoris,and it is safe. |
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