颅内脑动脉支架成形术中使用低剂量肝素安全性的随机、对照、先导性研究  

Safety of Low-Dose Heparin for Intracranial Stent-Assisted Angioplasty: A Randomized Controlled Pilot Study

作　　者：高峰[1] 杜彬[1] 徐晓彤[1] 王拥军[1] 姜卫剑[1] 

机构地区：[1]首都医科大学附属北京天坛医院脑血管病中心,北京市100050

出　　处：《中国卒中杂志》2010年第9期723-729,共7页Chinese Journal of Stroke

基　　金：国家科技部十五攻关课题(症状性颅内动脉狭窄支架成形术研究-2)(2004BA714B-7)

摘　　要：目的评估颅内脑动脉支架成形术使用低剂量肝素的安全性。方法本研究为前瞻性设计的随机、对照先导性研究,2004年10月至2006年3月于我中心行颅内脑动脉支架成形术符合入组标准的患者被随机分配到低剂量肝素组(2000Iu+500IU/h)和高剂量肝素组(3000Iu+800IU/h),主要终点事件为术中和住院期间支架内急性血栓形成、颅内出血、血管性死亡发生率,术中行活化凝血时间(activated clotting time,ACT)监测。比较两组上述指标的差异。结果共共入组64例患者(70处病变),低剂量肝素组33例患者(38处病变),高剂量肝素组31例患者(32处病变),总的技术成功率为93%(65/70处病变),低剂量肝素组技术成功率为94.7%(36/38),高剂量肝素组技术成功率为90.6%(29/32);低剂量肝素组急性血栓形成并发症为3.0%(1/33),高剂量肝素组为3.2%(1/31)(P=1.00);低剂量肝素组颅内出血并发症为3.0%(1/33),高剂量肝素组为12.9%(4/31)(P=0.19)。结论在颅内脑动脉支架成形术中使用低剂量的肝素,维持ACT值在"亚满意"的抗凝水平是安全的,并未增加术中急性血栓形成事件的发生率。Objective To access the safety of low-dose heparin in comparison to a high-dose regimen in patients undergoing intracranial stent-assisted angioplasty. Methods We performed a prospective random, double-blind, comparative study from Oct 2004 to Mar 2006. The patients undergoing intracranial stent-assisted angioplasty in our center were randomly assigned to receive low dose of heparin （2000 IU plus 500 1U/h） or high dose of heparin （3000 IU plus 800 lU/h） during the procedure. The groups were compared for the following primary endpoints until hospital discharge： target lesion acute thrombosis, intracranial hemorrhage （1CH） and death. The activated clotting time （ACT） was measured. Results The overall angioplasty success rate was 93% （65/70 lesions）. Stents were placed in 94.7% （36/38） and 90.6% （29/32） of patients in the low-dose and high-dose groups, respectively （P=0.65）. The low dose ofheparin group did not increase target-lesion thrombosis （3.0% vs 3.2%, P=1.00） and had a low risk of intracranial hemorrhage （3.0% vs 12.9%, P-0.19）. However, this difference was not statistically significant. Conelusion The use of a low-dose heparin regimen did not increase the incidence of target lesion thrombosis. Intraoperative low-dose heparin seems to be safe for patients undergoing intracranial stent-assisted angioplasty, but these data should be confirmed in a larger trial.

关 键 词：支架 血管成形术 肝素 

分 类 号：R743[医药卫生—神经病学与精神病学]