CAJ | 학술논문

目的：探讨国产注射用比伐卢定对急性ST段抬高型心肌梗死(STEMI)患者急诊介入治疗(PCI)术中凝血功能的影响及安全性评价。 　　方法：随机选择75例STEMI行急诊PCI的患者，术中用普通肝素（肝素组，n=35）或国产注射用比伐卢定（比伐卢定组，n=40）抗凝。分别于PCI术前、用药后5 min、术后即刻、停药后30 min、1h、2 h检测激活全血凝固时间(ACT)。用药前、用药结束后6、24、72 h静脉采血，检测凝血功能四项指标即活化部分凝血酶时间(APTT)、凝血酶原时间（PT）、凝血酶时间(TT)和纤维蛋白原(FIB)。 　　结果：比伐卢定组用药后5 min测定的ACT均能达到PCI手术所要求的ACT＞225 s，而肝素组有1例患者未能达到要求需要追加剂量。PCI术中两组均能维持ACT＞225 s。停药后，比伐卢定组较肝素组ACT降低，停药30 min、1 h、2 h的ACT值比伐卢定组均低于肝素组，差异均有统计学意义（P<0.05）。比伐卢定组与肝素组比较，术后凝血功能四项指标、PCI术后30 d无心脏事件生存率差异均无统计学意义（P均>0.05），PCI术后24 h内轻度出血的发生率降低（0 vs 11.43%）,差异有统计学意义（P<0.05）。 　　结论：与常规肝素抗凝相比，国产注射用比伐卢定作为抗凝剂应用于STEMI患者急诊介入治疗中，起效更快，效果更强，而且半衰期更短，提示国产比伐卢定可以安全有效地应用于急诊PCI术中的抗凝治疗。
목적：탐토국산주사용비벌로정대급성ST단태고형심기경사(STEMI)환자급진개입치료(PCI)술중응혈공능적영향급안전성평개。 　　방법：수궤선택75례STEMI행급진PCI적환자，술중용보통간소（간소조，n=35）혹국산주사용비벌로정（비벌로정조，n=40）항응。분별우PCI술전、용약후5 min、술후즉각、정약후30 min、1h、2 h검측격활전혈응고시간(ACT)。용약전、용약결속후6、24、72 h정맥채혈，검측응혈공능사항지표즉활화부분응혈매시간(APTT)、응혈매원시간（PT）、응혈매시간(TT)화섬유단백원(FIB)。 　　결과：비벌로정조용약후5 min측정적ACT균능체도PCI수술소요구적ACT＞225 s，이간소조유1례환자미능체도요구수요추가제량。PCI술중량조균능유지ACT＞225 s。정약후，비벌로정조교간소조ACT강저，정약30 min、1 h、2 h적ACT치비벌로정조균저우간소조，차이균유통계학의의（P<0.05）。비벌로정조여간소조비교，술후응혈공능사항지표、PCI술후30 d무심장사건생존솔차이균무통계학의의（P균>0.05），PCI술후24 h내경도출혈적발생솔강저（0 vs 11.43%）,차이유통계학의의（P<0.05）。 　　결론：여상규간소항응상비，국산주사용비벌로정작위항응제응용우STEMI환자급진개입치료중，기효경쾌，효과경강，이차반쇠기경단，제시국산비벌로정가이안전유효지응용우급진PCI술중적항응치료。
Objective: To evaluate the safety and anticoagulant efficacy of domestic bivalirudin injection during emergent percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Methods: A total of 75 STEMI patients were randomly divided into 2 groups according to anticoagulant used in emergent PCI procedure. Bivalirudin group, the patients received intravenous domestic bivalirudin, n=40 and Heparin group, n=35. The activated clotting time (ACT) was tested at pre-PCI, 5 minutes after medication, immediately after PCI, 30 minutes, 1 hour and 2 hours after medication respectively. The activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT) and ifbrinogen (FIB) level were measured at before medication and 6, 24, 72 hours after medication. Results: All patients in Bivalirudin group had ACT>225s at 5min after medication as PCI requirement, while 1 patient in Heparin group could not reach the requirement and the extra dose was added. Both groups maintained ACT>225s during PCI procedure. Bivalirudin group had the lower ACT levels than those in Heparin group at 30 min, 1-and 2-hour after the medication, P<0.05. The post-PCI levels of APTT, PT, TT and FIB were similar between 2 groups, all P>0.05. The no-cardiac event surviving rate at 30 days after PCI in Bivalirudin group and in Heparin group were similar P>0.05 and the mild bleeding at 24 hours after PCI in Bivalirudin group was lower (0 vs 11.43)%, P<0.05. Conclusion: Compared with heparin, domestic bivalirudin may take faster effect, with shorter half-life period for anticoagulation during emergent PCI procedure in STEMI patients.