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凝血酶原时间(PT)延长的肝硬化患者伴有凝血因子VⅡ水平低下,研究旨在评价在没有出血的肝硬化患者中重组Ⅶ_α因子rFⅦ_α对纠正PT延长的安全性、有效性和药物动力学。 方法:该试验是剂量递增式研究,时间为24天,1995年2～3月相继13例PT延长>参考值上限2秒以上的肝硬化患者,于第8天复查PT,仍延长达到此标准者接受Vit K 10mg肌肉注射,第10天再查PT,未纠正到正常上限2秒以内的10例患者入选试验,男8例,女2例,平均年龄45岁,Child B肝硬化3例,Child C肝硬化7例。在第10天、17天和24天分别给患
The aim of the study was to evaluate the safety, efficacy and pharmacokinetics of recombinant Ⅶ_α factor rFⅦ_α in correcting PT prolongation in cirrhotic patients with prolonged prothrombin time (PT) accompanied by a low level of clotting factor VⅡ . METHODS: The trial was a dose-escalation study of 24 days. From February to March 1995, 13 consecutive patients with cirrhosis who had an extension of PT> 2 seconds above the reference value were examined for PT on day 8 and were still extended to this standard 10 patients received Vit K intramuscular injection 10 days, and then check PT, uncorrected to the upper limit of normal within 2 seconds of 10 patients enrolled in the trial, 8 males and 2 females, mean age 45 years, 3 cases of Child B cirrhosis, Child C cirrhosis in 7 cases. On day 10, day 17 and day 24, respectively