磺达肝癸钠和低分子肝素钙治疗急性非ST段抬高型心肌梗死的疗效对比

摘要

目的比较磺达肝癸钠和低分子肝素钙对急性非ST段抬高型心肌梗死（NSTEMI）的临床疗效及安全性。方法纳入2011年10月～2013年3月间急性NSTEMI患者120例，随机分为对照组（n=56）和治疗组（n=64），所有患者均接受常规药物治疗，控制血压、血糖，对照组予低分子肝素钙0.1 ml/10 kg皮下注射（q12 h），连用7 d；治疗组给予磺达肝癸钠2.5 mg/d皮下注射（qd），连用7 d。于基线和首次给药2 h后检测血栓弹力图（thrombelastography，TEG），同时观察治疗7 d及30 d后主要不良心血管事件（MACE，包括再发心绞痛、再发心肌梗死、死亡、恶性心律失常）发生率及出血率。结果对照组与治疗组基线血栓弹力图反应时间（TEG-R，5.25 min vs.4.98 min）和治疗2 h后的TEG-R（11.05 min vs.13.40 min）均无统计学差异（P＞0.05）。治疗过程中对照组和治疗组MACE发生率无统计学差异（7 d：21.43%vs.6.25%；30 d：21.43%vs.9.38%；P均＞0.05）。治疗7 d后，两组严重出血发生率无统计学差异（5.36%vs.1.56%），但治疗组轻度出血发生率较对照组明显减少（3.13%vs.23.21%，P＜0.05）；治疗30 d后，治疗组严重出血（0 vs.7.14%）和轻度出血（4.69%vs.26.79%）发生率较对照组显著降低，两组差异有统计学意义（P＜0.05）。结论磺达肝癸钠与低分子肝素钙治疗NSTEMI同等有效且安全性更佳。%Objective To study and compare the curative effects and safety of fondaparinux and low-molecular-weight heparin calcium in treatment of non-ST-segment elevation myocardial infarction (NSTEMI). Methods The patients (n=120) with NSTEMI were chosen from Oct. 2011 to Mar. 2013, and then randomly divided into control group (n=56) and treatment group (n=64). All patients were given retuin therapy to control blood pressure and blood sugar. The control group was then given hypodermic injection of low-molecular-weight heparin calcium (0.1 mL/10 kg) for 7 days and treatment group, fondaparinux (2.5 mg/d) for 7 days. The changes of thrombelastography (TEG) were detected at baseline and after treatment for 2 hours, meanwhile the incidence of major adverse cardiovascular events (MACE, relapse angina, relapse myocardial infarction, death and malignant arrhythmia) and bleeding were observed in two groups. Results There was no significant difference in TEG-R between two groups (P>0.05) both at baseline (4.98 min vs. 5.25 min) and after 2 hours (13.40 min vs. 11.05 min). The incidence of MACE had no statistical difference between two groups during the treatment (7 d:21.43%vs. 6.25%;30 d:21.43%vs. 9.38%;all P>0.05). After treatment for 7 days, the incidence of severe bleeding had no statistical difference between two groups (5.36%vs. 1.56%), while that of mild bleeding decreased significantly in treatment group compared with control group (3.13%vs. 23.21%, P<0.05). After treatment for 30 days, the incidences of severe bleeding (0 vs. 7.14%) and mile bleeding (4.69%vs. 26.79%) decreased significantly in treatment group compared with control group (P<0.05). Conclusion Fondaparinux has the same curative effect and higher safety in the treatment of NSTEMI compared with low-molecular-weight heparin calcium.