口服提供抗凝剂剂量的肝素. 一个随机,双盲,对人类进行的受控研究
R A Baughman1, S C Kapoor, R K Agarwal
1EUPENN Clinical Trials Group, Center for Experimental Therapeutics, University of Pennsylvania School of Medicine, Philadelphia, USA.
Circulation
|October 20, 1998
概括
口服肝素与N-[8(-2-基) 氨基]酸 (SNAC) 在健康志愿者中显示出抗凝剂作用. 这项研究确定了口服肝素的可行性,可能提高患者的便利性和安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物输送系统 药物输送系统
- 生物化学 生物化学
背景情况:
- 门内肝素是入院患者的标准抗凝剂.
- 目前的替代品包括皮下低分子量肝素或口服华法林,每一种都有缺点.
- 口服肝素可以为现有治疗提供更方便,更安全的替代方案.
研究的目的:
- 为了评估口服肝素与输送剂,N-[8(-2-基) 氨基]酸 (SNAC) 结合的安全性和耐受性.
- 在健康志愿者中评估口服肝素和SNAC的抗凝效应.
- 为了确定口服肝素用于抗凝剂的可行性.
主要方法:
- 进行了一项随机,双盲,受控的临床研究.
- 在健康志愿者中,随着SNAC的使用,口服肝素剂量升级.
- 测量了关键抗凝剂指数,包括激活的部分血栓形成时间 (aPTT),抗因子IIa,抗因子Xa和组织因子通路抑制剂 (TFPI).
主要成果:
- 在健康志愿者中,口服肝素与SNAC显著增加了TFPI,抗因子IIa,抗因子Xa和aPTT.
- 没有观察到生命体征或实验室值的显著变化,这表明安全性良好.
- 一种含有肝素的SNAC口味掩饰制剂耐受性良好,并显示了剂量依赖的抗凝剂作用.
结论:
- 口服氨酸与SNAC结合使用,在人类中有效产生抗凝效应.
- 这项研究证明了口服肝素的可行性,为亲肠道给药提供了潜在的替代方案.
- 这些发现表明,对大分子药物的口服药物有更广泛的影响.
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