Lusher J M, Blatt P M, Penner J A, Aledort L M, Levine P H, White G C, Warrier A I, Whitehurst D A
Blood. 1983 Nov;62(5):1135-8.
In view of uncontrolled observations and anecdotal reports suggesting that the activated PCC, Autoplex, was much more effective than standard (non-activated) PCC in controlling bleeding in hemophiliacs with inhibitors, a controlled double-blind study was designed to compare the effectiveness of Autoplex and Proplex. Acute hemarthrosis was chosen for study as this common but non-life-threatening lesion lends itself well to controlled study. A single dose of "unknown" product (Autoplex 75 FECU/kg; Autoplex 50 FECU/kg; or Proplex 75 FIX U/kg) was given, and effectiveness was judged at 6 hr. By all criteria of efficacy, there were no significant differences between the products. It is noteworthy that a single dose of PCC was judged effective in 50% of episodes, a figure that is consistent with other published clinical trials. In this model, no additional benefit was derived from using the activated PCC, Autoplex, in either dosage.
鉴于非对照观察和传闻报告表明，活化的凝血酶原复合物（Autoplex）在控制有抑制剂的血友病患者出血方面比标准（未活化）凝血酶原复合物有效得多，因此设计了一项对照双盲研究来比较Autoplex和Proplex的有效性。选择急性关节积血进行研究，因为这种常见但不危及生命的病变很适合进行对照研究。给予单剂量的“未知”产品（Autoplex 75 FECU/kg；Autoplex 50 FECU/kg；或Proplex 75 FIX U/kg），并在6小时时判断有效性。根据所有疗效标准，各产品之间无显著差异。值得注意的是，单剂量凝血酶原复合物在50%的发作中被判定有效，这一数字与其他已发表的临床试验一致。在该模型中，使用任何一种剂量的活化凝血酶原复合物Autoplex均未获得额外益处。
