磺达肝癸钠治疗急性冠脉综合征的临床疗效及安全性研究*

目的:探讨磺达肝癸钠对急性非ST段抬高心肌梗死(NSTEMI)患者经皮冠状动脉介入治疗(PCI)的临床疗效及安全性。方法:入选164例接受PCI治疗的NSTEMI患者,将其随机分为观察组(82例)和对照组(80例)。观察组患者给予磺达肝癸钠治疗;对照组患者给予那曲肝素治疗。观察和比较两组治疗第10天的心脏事件(死亡、再梗死)及不良反应(出血)的发生率、凝血酶原时间(PT)及活化部分凝血活酶时间(APTT)、心脏功能(LVEDV、EF)及第30天的死亡率。结果:观察组与对照组第10天的死亡率[2.4%(2/82) vs. 3.7%(3/80),P=0.630]、新发梗死率[3.6%(3/82) vs. 5.0%(4/80),P=0.724],第30天的死亡率[1.2%(1/80) vs.6%(2/77),P=0.538],严重出血发生率[1.2%(1/82) vs. 2.5%(2/80),P=0.546]比较差异均无统计学意义。磺达肝癸钠组轻微出血发生率显著低于对照组[3.6%(3/82) vs. 12.5%(10/80),P=0.038],差异有统计学意义。与对照组比较,观察组的凝血时间显著延长[APTT(30.02±2.10) vs.(29.24±1.84),t=2.512,P=0.013;PT (13.62±1.34) vs.(12.24±1.20),t=6.89,P=0.000],心功能明显改善[LVEDV (35.80±1.62) vs.(36.25±1.22),t=1.993,P=0.048;EF(42.25±0.34) vs.(42.15±0.26),t=2.099,P=0.037]。结论:磺达肝癸钠在急性冠脉综合征行PCI治疗中的抗凝效果优于那曲肝素,其改善心功能的效果更好,且出血发生率低。

Efficacy and Safety of Fondaparinux in the Treatment of Patients with Acute Coronary Syndrome*

ABSTRACT Objective: To observe the clinical efficacy and safety of Fondaparinux in the treatment of patients with non-ST-elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention(PCI). Methods: 164 cses of patients with NSTEMI were randomly divided into the study group (82 cases) and the control group (80 cases). Patients in the study group were treated with Fondaparinux and patients in the control group were treated with Nadroparin The incidence of cardiac events (death, reinfarction) and adverse reactions (bleeding), changes of prothrombin time (PT) and activated partial thromboplastin (APTT) time, heart function (LVEDV, EF) on the 10th day of treatment, the mortality on the 30th day were compared between two groups. Results: The mortality on the 10th day (2.4% (2/82) vs. 3.7% (3/80), P=0.630), the incidence of reinfarction [3.6% (3/82) vs. 5. 0% (4/80), P=0. 724], the mortality on the 30th day [1.2% (1/80) vs. 2. 6% (2/77), P=0.538], the incidence of severe bleeding [1.2% (1 /82) vs. 2.5% (2/80), P0.546] showed no significant difference between the two groups. The incidence of mild hemorrhage in the group of Fondaparinux was significantly lower than that of the control grop[3.6% (3/82) vs. 12.5% (10/80), P=0.038], the coagulation time was prolonged [APTT (30.02±2.10) vs. (29.24±1.84), P=0.013; PT (13.62±1.34) vs. (12.24 ±1.20), P=0.000] and; the heart function was obviously improved in the observation group[LVEDV (35.80 ±1.62) vs. (36.25 ±1.22), P=0.048), EF (42.25 ±0.34) vs (42.15 ±0.26), P=0.037)](P<0.05). Conclusion: Compared with Nadroparin alone, Fondaparinux has excellent anticoagulant effect, it can better improve the heart function and lower incidence of bleeding in the treatment of patients with acute coronary syndrome undergoing PCI.