磺达肝癸钠对非ST段抬高急性冠脉综合征的疗效与安全性的研究

Study on the efficacy and safety of Fondaparinux in treating non-ST segment elevation acute coronary syndrome

目的观察对比磺达肝癸钠和那曲肝素对非ST段抬高急性冠脉综合征的临床疗效及安全性。方法将非ST段抬高急性冠脉综合征患者130例分为对照组(62例)和治疗组(68例),两组基础治疗相同,对照组给予那曲肝素0.1 mL/10 kg,皮下注射,每12小时1次,连用7 d。治疗组给予磺达肝癸钠2.5 mg/d,皮下注射,1次/d,连用7 d。观察治疗7 d及30 d后心脏事件发生情况。比较两组疗效及安全性。结果 7 d后,治疗组与对照组心血管事件(再发心绞痛、Q波性心肌梗死、死亡、室速、室颤)及严重出血(脑出血、腹膜腔出血、呕血)的发生例数比较,差异无统计学意义(P>0.05)。轻度出血(皮下瘀斑、牙龈出血、血尿、便血+++以下)并发症例数均较对照组明显减少(P<0.05)。30 d后,治疗组与对照组心血管事件的发生例数比较,差异仍无统计学意义(P>0.05)。严重出血及轻度出血并发症例数均较对照组明显减少(P<0.05)。结论磺达肝癸钠治疗非ST段抬高急性冠脉综合征安全有效。

Objective To observe and compare the efficacy and safety of Fondaparinux and Nadroparin in the treatment of non-ST segment elevation acute coronary syndrome.Methods A total of 130 patients with non-ST segment elevation acute coronary syndrome were randomly divided into control group（62 cases） and treatment group（68 cases）.Besides the basic treatment,0.1 mL/10 kg Nadroparin was administrated to the control group subcutaneously every 12 hours for 7 days.The treatment group was given Fondaparinux 2.5 mg per day subcutaneously for 7 days.Occurrences of cardiac disease were observed for 7 and 30 days.Results After 7 days,there were no significant differences in incidence of cardiac events（relapse angina,ST elevate myocardial infraction,death,ventricular tachycardia,ventricular fibrillation）,and the incidence of major bleeding（cerebral hemorrhage,peritoneal cavity hemorrhage,haematemesis） in treatment group and control group.The hyporrhea（subcutaneous ecchymosis,gingival bleeding,hematuria,hemafecia ＋＋＋ following） of treatment group was obvious decreased than control group（P〈0.055）.After 30 days,incidence of cardiac events was not significant different between two groups（P〈0.055）.The incidence of major bleeding and the hyporrhea of treatment group was obvious decreased than control group（P〈0.055）.Conclusion Fondaparinux in treating non-ST segment elevation acute coronary syndrome is safe and effective.