国产阿加曲班与比伐卢定在高出血风险急性心肌梗死患者急诊经皮冠状动脉介入治疗中临床疗效及安全性的对比研究

Comparative Study for Clinical Effect and Safety on High-risk Hemorrhage Acute Myocardial Infarction Patients Undergoing Emergency PCI between Domestic Argatroban and Domestic Bivalirudin

目的比较国产阿加曲班与比伐卢定在高出血风险急性心肌梗死患者急诊经皮冠状动脉介入(PCI)治疗中的临床疗效及安全性。方法选取2014年1月—2015年1月在绵阳市中心医院、德阳市人民医院、广元市中心医院、绵阳市三医院和绵阳市中医医院住院的急性心肌梗死患者158例,按照随机数字表法分为阿加曲班组和比伐卢定组,每组79例。患者PCI术前均直接嚼服氯吡格雷和阿司匹林,PCI术后长期服用阿司匹林,服用氯吡格雷至少30d。阿加曲班组患者术中给予国产阿加曲班治疗,比伐卢定组患者术中给予国产比伐卢定治疗。比较两组患者PCI术前,给药后5 min,手术结束,停药后30 min、1 h、2 h激活全血凝固时间(ACT),PCI成功率以及PCI术后24 h和30 d内出血发生率。结果 147例患者完成研究,其中阿加曲班组73例(6例患者因依从性差未完成研究),比伐卢定组74例(5例患者失访)。两组患者PCI术前和停药后2 h ACT比较,差异无统计学意义(P>0.05);比卢伐定组患者给药后5 min、手术结束、停药后30 min、停药后1 h ACT均高于阿加曲班组(P<0.05)。阿加曲班组患者PCI成功率为93.2%(68/73),比伐卢定组为91.9%(68/74),差异无统计学意义(P>0.05)。PCI术后24 h,阿加曲班组患者轻度出血发生率低于比伐卢定组(P<0.05);两组患者均未发生严重出血事件。PCI术后30 d,阿加曲班组患者轻度出血发生率低于比伐卢定组(P<0.05);两组患者严重出血发生率比较,差异无统计学意义(P>0.05)。结论对于高出血风险急性心肌梗死患者,急诊PCI术中给予国产阿加曲班的临床疗效及安全性较国产比伐卢定更好。

Objective To compare the clinical effect and safety on high-risk hemorrhage acute myocardial infarction patients undergoing emergency PCI between domestic argatroban and domestic bivalirudin.Methods From January 2014 to January 2015,a total of 158 patients with acute myocardial infarction hospitalized in Mianyang Central Hospital,Deyang People＇s Hospital,Guangyuan Central Hospital,the Third Hospital of Mianyang and the Traditional Chinese Medicine Hospital of Mianyang were selected,and they were divided into A group and B group according to random number table,each of 79 cases.Patients of both groups received direct chewing of clopidogrel and aspirin before PCI,long-time aspirin treatment after PCI,and clopidogrel need to take 30 days at least; patients of A group received domestic argatroban during PCI,while patients of B group received domestic bivalirudin during PCI.Activated clotting time was compared between the two groups before PCI,5minutes after taking relevant drugs,at the end of PCI,30 minutes,1 hour and 2 hours after drug discontinuance,respectively;PCI successful rate and the incidence of hemorrhage within 24 hours and 30 days after PCI were compared,too.Results A total of 147 patients successfully completed this study,including 73 cases in A group（6 cases dropped out caused by poor compliance）and 74 cases in B group（5 cases lose to follow-up）.No statistically significant differences of activated clotting time was found between the two groups before PCI or 2 hours after drug discontinuance（P〉0.05）; while activated clotting time of A group was statistically significantly lower than that of A group 5 minutes after taking relevant drugs,at the end of PCI,30 minutes and 1 hour after drug discontinuance,respectively（P〈0.05）.The PCI successful rate of A group was 93.2%（68 /73）,that of B group was 91.9%（68 /74）,the difference was not statistically significantly different（P〉0.05）.Within 24 hours after PCI,the incidence of mild hemorrhage of A group was statistically significantly lower than that of B group（P〈0.05）; no one of both groups occurred any severe hemorrhage（P〉0.05）.Within 30 days after PCI,the incidence of mild hemorrhage of A group was statistically significantly lower than that of B group（P〈0.05）,while no statistically significant differences of incidence of severe hemorrhage was found between the two groups（P〉0.05）.Conclusion The clinical effect and safety of domestic argatroban is better than that of domestic bivalirudin in treating high-risk hemorrhage acute myocardial infarction patients undergoing emergency PCI.