ANTIPLATELET EFFECT AND PHARMACOKINETIC COMPARISON OF ORAL VS RECTAL ASPIRIN

口服与直肠阿司匹林的抗血小板作用和药代动力学比较

• 批准号: 6113300
• 负责人: SARAH A SPINLER
• 金额: $ 2.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113300
• 关键词: aspirin; clinical research; clinical trial phase I; drug administration routes; drug screening /evaluation; fibrinolytic therapy; human subject; human therapy evaluation; oral administration; pharmacokinetics; platelet aggregation inhibitors; thromboxanes

Despite an absence of data demonstrating efficacy as an antiplatelet agent, rectal aspirin is currently being administered to hospitalized patients with acute myocardial ischemic syndromes who are unconscious or who cannot tolerate oral medications due to emesis or pathological conditions of the gastrointestinal tract. This randomized, double-blinded, placebo-controlled, complete crossover study, is designed to compare the onset and magnitude of effects of ex-vivo platelet aggregation and supression of thromboxane B2 production, between oral and rectal aspirin (325 mg tablet vs 300 suppository) in healthy middle-aged volunteers.

尽管缺乏数据证明阿司匹林作为抗血小板药物的有效性，但直肠阿司匹林目前被用于急性心肌缺血综合征的住院患者，这些患者由于呕吐或胃肠道病理状况而失去意识或不能耐受口服药物。这项随机、双盲、安慰剂对照、完全交叉研究，旨在比较健康中年志愿者口服和直肠阿司匹林（325mg片剂vs 300栓剂）对体外血小板聚集和血栓素B2产生抑制的开始和影响程度。