2种不同抗血小板方案在急性心肌梗死介入患者中的临床研究

Clinical trial of two different antiplatelet regimens in patients with acute myocardial infarction

目的 研究不同双联抗血小板方案(DAPT)在急性心肌梗死(AMI)进行经皮冠状动脉介入治疗(PCI)术后患者治疗中的疗效和安全性。方法 选取接受PCI的AMI患者,并用随机数字表分为试验组和对照组,试验组PCI术后给予西洛他唑(每次50 mg,bid)联合替格瑞洛(每次90 mg,bid),对照组PCI术后给予阿司匹林(100 mg,qd)联合氯吡格雷(75 mg,qd);2组疗程均为6个月,比较2组血小板活化和血管内皮功能相关指标,并记录随访治疗期间主要不良心血管事件(MACE)和药物不良反应发生情况。结果 试验过程中共脱落5例,最终试验组和对照组分别纳入98例和97例。治疗后,试验组和对照组的支架再狭窄发生率分别为2.04%(2例/98例)和9.27%(9例/97例),MACE发生率分别为4.08%(4例/98例)和13.40%(13例/97例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的2组血小板抑制率(IPA)分别为(54.97±6.43)%和(52.38±6.12)%,血清一氧化氮(NO)分别为(64.29±8.12)和(59.61±8.45)μmol·L^(-1),前列环素(PGI2)分别为(42.15±3.94)和(38.46±3.71) ng·L^(-1),最大血小板聚集率(MPAR)分别为(31.65±3.86)%和(32.97±4.25)%,血小板计数(PC)分别为(169.84±36.71)×10^(9)·L^(-1)和(172.63±38.94)×10^(9)·L^(-1),P-选择素(CD62P)阳性率分别为(24.58±5.34)%和(27.13±5.82)%,血小板激活复合物-1(PAC-1)阳性率分别为(7.63±2.15)%和(8.45±2.69)%,血清内皮素-1(ET-1)水平分别为(61.03±5.97)和(65.39±7.14)ng·L^(-1),试验组上述指标与对照组比较,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头痛、呼吸困难以及出血事件,对照组的药物不良反应主要有呼吸困难和出血事件。试验组和对照组的总药物不良反应发生率分别为11.22%(11例/98例)和9.28%(9例/97例),差异无统计学意义(P>0.05)。结论 AMI患者PCI术后应用西洛他唑联合替格瑞洛进行治疗有利于抑制血小板聚集和活化,减轻血管内皮功能损伤,降低支架内再狭窄和MACE发生风险。

Objective To study the efficacy and safety of different dual antiplatelet therapy(DAPT) in patients with acute myocardial infarction(AMI) undergoing percutaneous coronary intervention(PCI) treatment.Methods AMI patients receiving PCI treatment were randomly divided into treatment group and control group.The treatment group was given clopidogrel(50 mg,bid) combined with ticagrelor(90 mg,bid) after PCI,while the control group was given aspirin(100 mg,qd) combined with clopidogrel(75 mg,qd) after PCI.The treatment course for both groups was 6 months.Platelet activation and endothelial function-related indicators were compared between the two groups,and major adverse cardiovascular events(MACE) and adverse drug reactions were followed up during the treatment period.Results During the trial,5 cases dropped out,and finally,98 cases and 97cases were included in the treatment group and control group,respectively.After treatment,the incidence of stent restenosis in the treatment group and control group were 2.04%(2 cases/98 cases) and 9.27%(9 cases/97 cases),respectively;the incidence of MACE were 4.08%(4 cases/98 cases) and 13.40%(13 cases/97 cases),respectively,with significant differences between the two groups(P <0.05).After treatment,the inhibition of platelet aggregation(IPA) in the treatment group and control group were(54.97±6.43)% and(52.38±6.12)%,respectively;the serum nitric oxide(NO) levels were(64.29±8.12) and(59.61±8.45) μmol·L^(-1),respectively;the prostacyclin(PGI2) levels were(42.15±3.94) and(38.46±3.71) ng·L^(-1),respectively;the maximum platelet aggregation rate(MPAR) were(31.65±3.86)% and(32.97±4.25) %,respectively;the platelet count(PC) were(169.84±36.71)×10^(9)·L^(-1) and(172.63±38.94)×10^(9)·L^(-1),respectively;the positive rates of P-selectin(CD62P) were(24.58±5.34) % and(27.13±5.82) %;the positive rates of platelet activated complex-1(PAC-1) were(7.63±2.15) % and(8.45±2.69) %;serum endothelin-1(ET-1) levels were(61.03±5.97) and(65.39±7.14) ng·L^(-1),which were significantly reduced compared with those before treatment(all P<0.05).The adverse drug reactions in treatment group were mainly headache,dyspnea and bleeding events,and the adverse drug reactions in control group were mainly dyspnea and bleeding events.The total incidence rates of adverse drug reactions in treatment group and control group were 11.22%(11 cases/98 cases) and 9.28%(9cases/97 cases),respectively(P>0.05).Conclusion Cilostazol combined with ticagrelor in patients with AMI after PCI is beneficial to inhibiting the platelet aggregation and activation,relieving the vascular endothelial function injury and reducing the risk of in-stent restenosis and MACE,and it has obvious advantages over aspirin combined with clopidogrel.