机构地区:[1]浙江大学医学院附属第一医院心内科,310003 [2]浙江大学医学院附属第一医院心血管病研究所,310003
出 处:《中华心血管病杂志》2004年第10期879-883,共5页Chinese Journal of Cardiology
基 金:浙江省科技攻关基金资助项目 ( 2 0 0 4C3 3 0 2 5 )
摘 要:目的 比较冠状动脉介入治疗术 (PCI)中静脉注射 2种不同剂量那屈肝素的抗血栓疗效 ,明确取得理想抗血栓疗效的最佳剂量。方法 采用前瞻性、随机、双盲的设计 ,共入选 4 2例因患冠心病需行PCI术的患者 ,随机分为小剂量那屈肝素组 (0 0 75ml/10kg)及大剂量组 (0 1ml/10kg)。PCI术前静脉注射那屈肝素 ,分别在注射前、注射后 8min、1h、2h和 4h ,用发色底物法测定血浆抗Ⅹa因子活性。同时还观察了出血指数 (定义为PCI治疗术后 2 4h内血红蛋白的下降值 )及 30d内出血事件。结果 (1)小剂量组注射那屈肝素前、注射后 8min及 1h血浆抗Ⅹa因子活性分别为(0 10± 0 0 0 )IU/ml、(1 89± 0 2 4 )IU/ml、(0 96± 0 2 4 )IU/ml,均与大剂量组相应时间点的血浆抗Ⅹa因子活性 [分别为 (0 10± 0 0 0 )IU/ml,(1 89± 0 30 )IU/ml,(0 93± 0 14 )IU/ml]相似 (P值分别为 0 16 2、0 96 2和 0 70 2 )。那屈肝素注射后 2h及 4h ,小剂量组抗Ⅹa因子活性 [分别为 (0 4 7± 0 13)IU/ml和 (0 30± 0 12 )IU/ml]低于大剂量组 [分别为 (0 75± 0 14 )IU/ml和 (0 4 5± 0 0 8)IU/ml,P值均小于 0 0 0 1]。(2 )小剂量组的出血指数 (3 3± 3 8) g/L与大剂量组 (0 2± 6 4 )g/L相似 (P =0 0 6 1)。 (3)二?Objective This study was designed to compare the antithrombotic properties of two differen t dose(0.075 ml/10kg vs. 0.1ml/10kg) of natroparin measured by anti-Ⅹ a levels during percutaneous coronary intervention(PCI). Methods The study had a prospective, double blind, randomized design. A total of 42 patients(age 64.4±9.4 years, female, 12%, diabetes, 14%)undergoing elective PCI(stable angina, 43%, unstable angina, 21%, two or three-vessel disease, 19%, stent, 100%) were randomized to administer intravenously either low dose (0.07 5 ml/10 kg) or high dose (0.1 ml/10 kg) natroparin for procedural anticoagulati on. Blood sample for anti-Ⅹa level were assayed before and after natroparin a dministration at the following interverals: 8 min, 1 h, 2 h and 4 h. Bleeding c omplications were classified according to Thrombolysis in Myocardial Infarction (TIMI) criteria. The bleeding index (change in hemoglobin) was calculated. All p atients were monitored for adverse clinical events (i.e. death, myocardial infar ction, need for revascularization) at 30 days after PCI. Results (1) Baseline characteristics were similar in both groups. (2) Plasma anti- Ⅹa activities were (0.10±0.00)_IU/ml at the time just before the administ ration of natroparin, (1.89±0.24) _IU/ml and (0.96±0.24) IU/ml at the time 8 min. and 1 h after the use of low dose natroparin, and were comparable w ith those at the same time in high dose group [(0.10±0.00)IU/ml, (1.89±0. 30)IU/ml, (0.93±0.14)IU/ml, P = 0.162,1.962 and 0.702, respectively] . Plasma anti-Ⅹa levels were lower at 2 h [(0.47±0.13)IU/ml] and 4 h [ (0.30±0.12)IU/ml]in low dose group than those at the same time [(0.75±0. 14)IU/ml, (0.45±0.08)IU/ml, respectively] in high dose group (P all <0. 001). (3) None of the patients from those two groups has been observed hemorrhag ic events. The bleeding index was (3.3±3.8)g/L in low dose group and was comp arable to (0.2±6.4)g/L in high dose group (P=0.061). No death, no recurr ent angina pectoris, no myocardial
关 键 词:肝素 抗血栓 静脉注射 大剂量 小剂量 XA因子 不同剂量 维持 发现 血红蛋白
分 类 号:R543[医药卫生—心血管疾病]
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