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阿昔单抗和替罗非班在周围动脉闭塞性疾病和动脉血栓形成患者中的应用。

Use of abciximab and tirofiban in patients with peripheral arterial occlusive disease and arterial thrombosis.

作者信息

Schweizer Johannes, Kirch Wilhelm, Koch Reiner, Müller Axel, Hellner Grit, Forkmann Lutz

机构信息

Internal Medicine Unit, Chemnitz Hospital, Chemnitz, Germany.

出版信息

Angiology. 2003 Mar-Apr;54(2):155-61. doi: 10.1177/000331970305400203.

Abstract

Acute peripheral arterial occlusive disease is an important factor affecting the mobility and mortality rate of elderly patients. Catheter-guided arterial thrombolysis in these patients has its limitations: long lysis times, early occlusions, and high restenosis rates. The study investigated whether the use of tirofiban has the same favorable effect as the glycoprotein (GP) IIb/IIIa receptor antagonist abciximab and whether lysis times can be shortened and the disease course positively influenced by these substances. Sixty patients were randomly assigned to 2 groups. Each group received 5 mg recombinant tissue-type (rt-PA) plasminogen activator by slow intra-arterial injection for 10 minutes followed by 5 mg rt-PA per hour and 500 IU heparin per hour IV. After randomization 1 group received a bolus of 0.25 mg abciximab per kg body weight followed by 10 mg per minute IV for 12 hours (heparin was reduced to 250 IU/hr). The other group received a bolus of 0.4 microg tirofiban per kg body weight as well as postinterventional medication with 0.1 microg tirofiban per minute and kg body weight for 24 hours. During medication with GP IIb/IIIa inhibitor, the patients received a reduced heparin dosage for 24 hours. After 24 hours both groups received 200 mg aspirin orally and full heparinization controlled on the basis of the partial thromboplastin time. The following efficacy criteria were analyzed: rehospitalization events, reintervention events, and amputations within 6 months. Secondary endpoints were changes in the Fontaine stage, the crurobrachial index, the distance to claudication, and the duration of local arterial lysis. No significant differences were found between the abciximab and tirofiban groups in terms of the rehospitalization, reintervention, or amputation rates, nor were there any group differences in the total number of events. The secondary parameters, such as the crurobrachial index, distance to claudication, and Fontaine stage, also showed no significant differences between the 2 groups within 6 months. The duration of lysis was significantly shorter in the abciximab group. Major bleeding events did not occur in either group. With regard to the adverse effect rate, there were no significant differences between the 2 groups. Both abciximab and tirofiban can be used successfully in patients with peripheral arterial occlusive disease and arterial thrombosis.

摘要

急性外周动脉闭塞性疾病是影响老年患者活动能力和死亡率的重要因素。对这些患者进行导管引导下动脉溶栓有其局限性:溶栓时间长、早期再闭塞以及再狭窄率高。该研究调查了替罗非班的使用是否与糖蛋白(GP)IIb/IIIa受体拮抗剂阿昔单抗具有相同的良好效果,以及这些药物是否能缩短溶栓时间并对病程产生积极影响。60例患者被随机分为2组。每组通过动脉内缓慢注射5mg重组组织型(rt-PA)纤溶酶原激活剂,持续10分钟,随后每小时注射5mg rt-PA和每小时静脉注射500IU肝素。随机分组后,1组接受每千克体重0.25mg阿昔单抗的静脉推注,随后以每分钟10mg的速度静脉注射12小时(肝素减至每小时250IU)。另一组接受每千克体重0.4μg替罗非班的静脉推注以及介入治疗后以每分钟每千克体重0.1μg替罗非班的剂量用药24小时。在使用GP IIb/IIIa抑制剂期间,患者24小时内接受减少剂量的肝素。24小时后,两组均口服200mg阿司匹林并根据部分凝血活酶时间进行全量肝素化控制。分析了以下疗效标准:6个月内的再次住院事件、再次干预事件和截肢情况。次要终点是Fontaine分期、股肱指数、间歇性跛行距离和局部动脉溶栓持续时间的变化。在再次住院、再次干预或截肢率方面,阿昔单抗组和替罗非班组之间未发现显著差异,两组在事件总数上也无组间差异。在6个月内,两组的次要参数,如股肱指数、间歇性跛行距离和Fontaine分期,也未显示出显著差异。阿昔单抗组的溶栓持续时间明显更短。两组均未发生严重出血事件。在不良反应发生率方面,两组之间无显著差异。阿昔单抗和替罗非班均可成功用于外周动脉闭塞性疾病和动脉血栓形成的患者。

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