Gomperts E D, Fannon R B, Lee M L, Kingdon H S, Kantrowitz J L, Addiego J E, Carney J, Corrigan J J, Hathaway W, Hilgartner M W
Thromb Res. 1986 Jun 15;42(6):789-96. doi: 10.1016/0049-3848(86)90115-5.
A blinded randomized multicenter trial of two non-activated prothrombin complex concentrates was carried out to determine the clinical effectivity in the treatment of acute hemarthrosis in hemophiliac patients with inhibitors. The one product was prepared via DEAE Sephadex chromatography, while the second was fractionated via various precipitation procedures including polyethylene glycol. Equivalence of the two products was established with less than 15% difference in efficacy rates.
开展了一项针对两种未激活凝血酶原复合物浓缩剂的双盲随机多中心试验，以确定其在治疗患有抑制剂的血友病患者急性关节积血方面的临床有效性。一种产品通过二乙氨基乙基葡聚糖凝胶色谱法制备，而另一种则通过包括聚乙二醇在内的各种沉淀程序进行分级分离。两种产品的等效性得以确立，有效率差异小于15%。
