摘要
目的 比较经皮冠状动脉介入治疗(PCI)中静脉注射那屈肝素或普通肝素的抗血栓疗效及安全性。方法 采用前瞻性、随机、单盲、多中心研究的设计,共入选98例因患冠心病需行PCI的患者,随机分为那屈肝素组(0 .075ml/10kg,手术时间超过1h补充半量)及普通肝素组( 100U/kg,手术时间超过1h补充2000U)。PCI前静脉注射那屈肝素或普通肝素。那屈肝素组前22例患者分别在注射前、注射后8min、1h、2h和4h,用发色底物法测定血浆抗Ⅹa因子活性。出血程度的判断根据TIMI研究的标准进行。结果 (1)性别、年龄、体重、血压、血红蛋白含量、红细胞压积、合并糖尿病的例数、冠心病类型、进行冠状动脉介入治疗的部位、介入治疗的手术方式及术前血浆cTNI>2ng/ml的例数在二组之间分布均衡,差异均无统计学意义; (2)那屈肝素组前22例患者血浆抗Ⅹa因子活性测定显示,用药前、用药后8min、1h、2h及4h血浆抗Ⅹa因子活性分别为( 0 .10±0. 00 )IU/ml、(1. 89±0 .24)IU/ml、(0 .96±0 .24)IU/ml、( 0 .47±0. 13 )IU/ml和( 0 .30±0 .12 )IU/ml。注射那屈肝素后8min及1h,所有患者血浆抗Ⅹa因子活性均在治疗水平( >0 .5IU/ml),注射后2h及4h分别仅有45%及9%的患者血浆抗Ⅹa因子活性维持在治疗水平。(3)那屈肝素组术后血红蛋白数量、红细?
Objective The study was designed to compare the antithrombotic property and safety between natroparin and unfractionated heparin during percutaneous coronary intervention (PCI).Methods A prospective, single blind, randomized study was performed. A total of 98 patients (aged 65.1±8.6 years, female,28.6%, diabetes, 7.1%) undergoing selective PCI were randomized to be administered intravenously either natroparin (0.075 ml/10 kg) or unfractionated heparin (100U/ kg) for procedural anticoagulation, in whom stable angina was 42.9%, unstable angina, 27.6%, myocardial infarction, 29.6%, two or three-vessel disease, 23.5%, stent, 100%. Blood samples for anti-Ⅹa level were assayed in the first 22 patients of the natroparin group before and after administration at the following intervals: 8 min, 1 h, 2 h and 4 h. Bleeding complications were classified according to Thrombolysis In Myocardial Infarction (TIMI) criteria. The bleeding index (change in hemoglobin) was calculated. All patients were monitored for adverse clinical events (i.e. death, myocardial infarction, need for revascularization) during the period of 30 days after PCI.Results (1) There were no significant differences in baseline characteristics between the two randomized groups. (2) Plasma anti-Ⅹa activities were 0.10±0.00 IU/ ml at the time just before the administration of natroparin, 1.89±0.24 IU/ ml, 0.96±0.24 IU/ ml, 0.47±0.13 IU/ ml, and 0.30±0.12 IU/ ml at the time of 8 min, 1 h, 2 h and 4 h after the use of natroparin (and the rate of >0.5 IU/ ml were 100%, 100%, 45% and 9% patients) , respectively. (3)There were no significant differences in the mean bleeding index, post-PCI hemoglobin and hematocrit between natroparin and unfractionated heparin group [(1.16±5.80) g/L vs (0.90±6.50) g/L, P=0.858;(129.5±13.6) g/L vs (125.5±14.9 ) g/L , P=0.175;(39.0±3.9)% vs (37.9±4.6)%, P=0.205]. (4) None of the patients in two randomized groups were observed hemorrhagic events, which including TIMI major or minor bleeding complications, gross or microscopic hematuria, melena, positive stool occult blood. There were no blood transfusions and no hematoma at the vascular access site in either of the group. (5) No death, no recurrent angina pectoris, and no urgent revascularization occurred within 30 days in both groups. One patient in natroparin group was observed “no reflow” phenomenon that was accompanied with an elevated ST segment and a risen serum level of cTnI. This patient was diagnosed as non-Q-wave myocardial infarction. Though no myocardial infarction was found in unfractionated heparin group, there was no significant difference in the rate of myocardial infarction between the two groups of the study (P= 0.970). Conclusions The administration of natroparin before PCI seems effective and safe. Compared with unfractionated heparin, natroparin was associated with neither an excess of bleeding nor an increase of clinical complications in this study.
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
2005年第4期335-339,共5页
Chinese Journal of Cardiology
基金
浙江省科技攻关项目基金资助(2004C33025)
