国产阿加曲班在择期经皮冠状动脉介入治疗中应用的安全性和有效性  

Anticoagulant efficacy and safety of argatroban for patients undergoing elective percutaneous coronary intervention

作　　者：田峰[1] 于虎[1] 陈韵岱[1] 刘宏斌[1] 郭军[1] 孙志军[1] 金琴花[1] 晏菲[1] 马云玲[1] 辜小芳[1] 

机构地区：[1]解放军总医院心内科,北京100853

出　　处：《中华心血管病杂志》2013年第6期480-483,共4页Chinese Journal of Cardiology

摘　　要：目的评价国产阿加曲班在择期经皮冠状动脉介入治疗（PCI）中应用的安全性及有效性。方法连续入选行择期PCI的冠心病患者300例。采用随机数字法，将患者分为普通肝素组（150例）和阿加曲班组（150例）。普通肝素组以100U／kg普通肝素抗凝；阿加曲班组先静脉注射国产阿加曲班负荷量（200u晷／kg），随后以350P,g·kg-1·h-1维持至手术结束。分别在给药后10、60min和手术结束时检测激活全血凝固时间（ACT）。如果术中ACT值〈250s，则追加普通肝素或阿加曲班。同时检测术前、给药后10min和手术结束后60min的活化部分凝血活酶时间（AtrI-y）。观察术中和住院期间的出血及血栓形成事件。结果在给药后10min，两组的ACT值均≥250S，普通肝素组的ACT值显著大于阿加曲班组[（343．32．±44．70）s比（289．60±20．88）s，P〈0．01]；给药后60min，两组的ACT值差异无统计学意义[（291．26±46．79）s比（288．40±21．61）s，P〉0．05]。阿加曲班组给药后10和60min的ACT值差异无统计学意义（P〉0．05）。普通肝素组有13例（8．7％）患者因ACT值〈250s追加药物，而阿加曲班组有2例（1．3％），差异有统计学意义（P〈0．05）。手术结束时，普通肝素组ACT值小于阿加曲班组[（247．16±41．38）s比（278．65±20．51）S，P〈0．01]。给药后10min[（182．16±4．37）s比（81．69±21．49）s，P〈0．01]和手术结束后60min[（169．13±6．35）s比（56．21±15．68）s，P〈0．01]，普通肝素组的APTI？值均显著高于阿加曲班组。两组患者在PCI术中均无指引导管和动脉鞘管内血栓形成；住院期间出血事件的发生率普通肝素组和阿加曲班组分别为2．0％（3／150）和0（P〉0．05）。结论冠心病患者择期PCI术中应用国产阿加曲班抗凝安全、有效，其抗凝效果不劣于普通肝素，并且出血发生率相似。Objective To investigate the anticoagulant efficacy and safety of argatroban for patients undergoing elective percutaneous coronary intervention （PCI）. Methods A total of 300 consecutive patients with coronary heart disease undergoing elective PCI were enrolled and randomized into heparin group （ 100 U/kg via artery sheaths, n = 150） and argatroban group （200μg/kg bolus, followed by 350μg· kg-1 h-1 i.v. infusion, n = 150）. The primary efficacy endpoint was the activated clotting time （ACT） results （ 10 min and 60 min after anticoagulant administration and at the point at the end of PCI）. The additional dosage of heparin or argatroban was given if the ACT value during PCI procedure 〈 250 s. Activated partial thromboplastin time （AI：WI＇） was also measured at pre-procedure, 10 min after anticoagulant injection and 60 rain after PC1. The primary safety endpoint was thrombosis and hemorrhagic events during PCI procedure and hospital stay. Results All patients in the two groups attained the target ACT （ ≥250 s）, and ACT in heparin group was significantly prolonged [ （343.32 ±44.70）s vs. （289. 60 ±20. 88） s, P 〈0. 01 ], at 10 min after anticoagulation injection. ACT was similar between the two groups at 60 min after anticoagulation injection [ （ 291.26 ± 46. 79 ） s vs. （ 288.40 ± 21.61 ） s, P 〉 0. 05 ]. The ACT value in argatroban group was similar at 10 rain and 60 min after injection （ P 〉 0. 05 ）. Supplemental anticoagulant was needed for 13 （ 8.7% ） patients in heparin group and 2 （ 1.3% ） patients in argatroban group because of ACT under 250 s （ P 〈 0. 05）. At the end of PCI procedure, ACT in heparin group was significantly shorter than in argatroban group [ （247. 16 ± 41.38 ） s vs. （ 278.65 ± 20. 51 ） s, P 〈 0. 01 ]. AlYFT in heparin group was significantly prolonged than in argatroban group not only at 10 min point [ （182. 16 ± 4.37 ）s vs. （81.69 ± 21.49）s, P 〈0.01] after anticoagulant injection but also at

关 键 词：冠状动脉疾病 血管成形术 经腔 经皮冠状动脉 抗凝药 

分 类 号：R541[医药卫生—心血管疾病]