出血高危风险非ST段抬高型急性心肌梗死患者应用磺达肝癸钠的临床研究

Clinical Research of Fondaparinux in the Treatment of Non-ST-segment Elevation Acute Myocardial Infarction Patients with High Risk of Bleeding

目的:观察出血高危风险非ST段抬高急性心肌梗死(NSTEAMI)患者应用磺达肝癸钠进行抗凝治疗的疗效及安全性。方法:病例来源于在本院住院治疗的NSTEAMI且按照CRUSADE计分≥41分的200例患者,按照随机数字表法将其分为磺达肝癸钠组和依诺肝素组,每组100例。观察两组患者治疗9、30、180 d的主要心血管事件发生率及出血发生率。评价在NSTEAMI患者中应用磺达肝癸钠至发病第9天时预防死亡或再次心肌梗死情况是否优于对照组;评价磺达肝癸钠预防死亡或再次MI方面优于对照药的作用是否持续至第9、30、180天。以严重出血评价至发病第9天时使用磺达肝癸钠和对照药物的安全性。结果:磺达肝癸钠组和依诺肝素组治疗9、30、180 d的主要心血管事件发生率比较差异均无统计学意义(P>0.05)。磺达肝癸钠组治疗9、30、180 d时各种出血事件的发生率分别为6.0%、8.0%和10.0%,均明显低于依诺肝素组的17.0%、20.0%和22.0%,比较差异均有统计学意义(P<0.05)。结论:在出血高危的NSTEAMI患者中磺达肝癸钠可有效地降低心血管事件发生率,不增加严重出血发生率,与依诺肝素相比,更安全有效。

Objective：To observe the efficacy and safety of Fondaparinux in the treatment of NSTEAMI patients with high risk of bleeding.Method：200 NSTEAMI patients with high risk of bleeding admitted to our hospital and according to the CRUSADE score ≥ 41 points were divided into the Fondaparinux group and the Enoxaparin group according to the random number table method,100 cases in each group.The incidence of major cardiovascular events and bleeding rate at 9,30 days and 180 days between the two groups were observed.Prevention of death or myocardial infarction of Fondaparinux application to ninth days of onset in NSTEAMI patients whether or not better than the control group was evaluated,evaluated the effects on prevention of death or myocardial infarction of Fondaparinux better than control drug whether continued to 9,30,180 days.Severe bleeding at ninth days were used to evaluate the safety of Fondaparinux and drug control.Result：There were no statistically significant differences in incidence of major cardiovascular events between the Fondaparinux group and the Enoxaparin group treatment for 9,30,180 days（P〈0.05）.The incidence of various bleeding events in the Fondaparinux group at 9,30,180 days were 6.0%,8.0%,10.0%,which were significantly lower than 17.0%,20.0% and 22.0% in the Enoxaparin group,the differences were statistically significant（P〈0.05）.Conclusion：In NSTEAMI patients with the high risk of bleeding,Fondaparinux can effectively reduce the incidence of serious bleeding,does not increase the incidence of cardiovascular events,it is safer and more effective than Enoxaparin.