磺达肝癸钠与那屈肝素在非ST段抬高急性冠脉综合征病人PCI治疗中的疗效及安全性对比

Efficacy and Safety of Fondaparinux and Nadroparin in Patients with non-ST Elevation Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention

目的探讨磺达肝癸钠与那屈肝素在非ST段抬高急性冠脉综合征(STEMI-ACS)病人经皮冠状动脉介入(PCI)治疗中的疗效及安全性。方法选取我院2013年—2016年收治的非ST段抬高急性冠脉综合征病人100例,按照随机数字表法随机分为对照组和试验组,每组50例。试验组为磺达肝癸钠组,接受磺达肝癸钠治疗;对照组为那屈肝素组,接受那屈肝素治疗。两组均在PCI早期分别接受两种药物治疗。普通肝素剂量7000~10000U(120~140U/kg)为两组病人在PCI期间所接受普通肝素剂量,5 000~7 000U(85~100U/kg)为合用替罗非班时的剂量。在PCI术后48h内并发症严重穿刺部位、住院期间轻微和严重出血均为主要安全性终点。再次靶血管血运重建、新发心肌梗死和住院期间死亡为主要治疗终点。结果两组临床资料、人口统计学特征、不良习惯等数据间差异无统计学意义(P>0.05)。两组在PCI术前的药物研究疗程和术后药物研究疗程差异无统计学意义(P>0.05)。常规其他用药在两组间的比较差异无统计学意义。两组手术特征和冠状动脉造影比较差异无统计学意义。两组手术成功率之间比较差异也无统计学意义。安全性主要终点发生率对照组高于试验组,比值为7.7%和5.4%;两组风险比值为试验组:对照组为0.64,其95%可信区间0.28~1.33,两组比较差异无统计学意义(P>0.05);主要疗效终点发生率那屈肝素组高于磺达肝癸钠组,比值为4.7%和2.8%,两组风险比值为试验组:对照组为0.67,其95%可信区间0.29~2.57,两组比较差异无统计学意义(P>0.05);轻微出血发生率那屈肝素组高于磺达肝癸钠组(4.5%和2.3%),两比较差异无统计学意义(P>0.05);严重出血发生率两组间基本相似(2.5%和2.4%)。结论在NSTEIACS病人PCI期间接受高于平常剂量普通肝素治疗的情况下,磺达肝癸钠与那屈肝素的应用在围术期时的疗效和安全性无差别。

Objective To compare and analyze the efficacy and safety of fondaparinux and nadroparin in patients with non-ST elevation acute coronary syndrome（NSTE-ACS）undergoing percutaneous coronary interventim（PCI）.Methods One hundred patients with NSTE-ACS in our hospital from2013 to 2016 were selected and randomly divided into two groups：control group treated with nadroparin,and treatment group treated with fondaparinux.The general heparin was 7 000 U to 10 000 U（120 U/kg to 140 U/kg）at the period of PCI,5 000 U to 7 000 U（85 U/kg to 100 U/kg）at the combined use of tirofiban.Complications of severe puncture site within 48 hours after PCI,mild and severe bleeding during hospitalization were the primary safety endpoint.Target vessel revascularization,new-onset myocardial infarction and death during hospitalization were as the primary endpoints of treatment.Results There was no significant differences in clinical data,demographic characteristics,bad habits and other data between two groups（P 0.05）.There was no significant differences in the preoperative and postoperative course of drug treatment between two groups（P 0.05）.There was no significant differences in routine drugs between two groups（P 0.05）.There was no significant differences in surgical features,coronary angiography,success rate of surgery between two groups（P 0.05）.The incidence of primary safety endpoint were 7.7%in treatment group,and 5.4%in control group[risk ratio（RR）=0.64,95% confidence interval（CI）：0.28-1.33,P 0.05].The incidence of primary endpoint was 2.8%in treatment group,and 4.7% in control group（RR =0.67,95%CI：0.29-2.57,P 0.05）.Minor bleeding rate was 2.3%in treatment group,and 4.5% in control group,the difference was not statistically significant between two groups（P 0.05）.The incidence of severe bleeding was 2.4%in treatment group,and 2.5%in control group,the difference was not statistically significant between the two groups（P 0.05）.Conclusion There was no difference in the efficacy and safety of fondaparinux and nadroparin in patients with NSTE-ACS at perioperative use with more than usual doses of unfractionated heparin.