比伐卢定用于经皮冠状动脉介入术围手术期高出血风险患者的安全性

Safety of Bivaludine in patients with high perioperative bleeding risk undergoing percutaneous coronary intervention

目的探讨比伐卢定用于经皮冠状动脉介入治疗(PCI)围手术期高出血风险患者的安全性评价。方法选取2020年3月至2021年2月萍乡矿业集团有限责任公司总医院的60例进行PCI治疗并在围手术期使用肝素抗凝的高出血风险患者作为对照组,选取2021年3月至2022年2月萍乡矿业集有限责任公司总医院的60例进行PCI治疗的高出血风险患者作为观察组,观察组使用比伐卢定进行抗凝治疗。随访12个月,观察两组患者术后心血管不良事件(MACE)、出血事件的发生情况、心肌损伤相关指标水平、围手术期活化凝血时间(ACT)。结果随访12个月期间,观察组患者MACE总发生率低于对照组,差异有统计学意义(P<0.05);观察组患者出血事件总发生率低于对照组,差异有统计学意义(P<0.05);术后24 h,两组患者肌酸激酶同工酶(CK-MB)、心肌肌钙蛋白(cTnⅠ)水平低于本组术前,差异有统计学意义(P<0.05);两组患者ACT水平在用药前、用药后5 min、30 min,手术结束后6 h比较,差异均无统计学意义(P>0.05),手术结束后1 h,观察组患者ACT水平低于对照组,差异有统计学意义(P<0.05)。结论比伐卢定应用于PCI围手术期高出血风险患者心肌保护效果与肝素相似,且能够减少MACE和术后出血事件的发生,抗凝作用更稳定,具有较高的安全性。

Objective To explore the safety evaluation of Bivaludine for patients with high perioperative bleeding risk un-dergoing percutaneous coronary intervention(PCI).Methods Sixty high bleeding risk patients who underwent PCI treatment at the General Hospital of Pingxiang Mining Group Co.from March 2020 to February 2021 and were treated with Heparin Sodium anticoagulation during the perioperative period were selected as the control group.Sixty high bleeding risk patients who underwent PCI treatment from March 2021 to February 2022 were selected as the observation group and treated with Bivaludine anticoagulation.Follow up for 12 months,observe the incidence of postoperative cardiovascular adverse events(MACE),bleeding events,levels of myocardial injury related indicators,and perioperative activated clotting time(ACT)in both groups of patients.Results During the folow-up period of 12 months,the total incidence of MACE in observation group was lower than that in control group,with statistical significance(P<0.05).The total incidence of bleeding events in obser-vation group was lower than that in control group,and the difference was statistically significant(P<0.05).24 h after opera-tion,the levels of creatine kinase-MB isoenzyme(CK-MB)and cardiac troponin I(cTnI)in the two groups were lower than before operation,and the differences were statistically significant(P<0.05).There was no significant difference in ACT level between the two groups before medication,5 min after medication,30 min after medication,and 6 h after surgery(P>0.05).1 h after surgery,the ACT level of the observation group was lower than that of the control group,with statistical significance(P<0.05).Conclusion The application of Bivaludine in patients with high perioperative bleeding risk during PCI has a similar myocardial protective effect to Heparin,and can reduce the occurrence of MACE and postoperative bleeding events.The anticoagulant effect is more stable and has higher safety.