Rossiter S J, Miller D C, Raney A A, Oyer P E, Reitz B A, Stinson E B, Shumway N E
J Thorac Cardiovasc Surg. 1979 Aug;78(2):203-7.
Experience with the clinical use and hepatitis risks of factor IX concentrate (Proplex) in cardiac surgical patients is presented in this report. Seventy-five patients received the concentrate for severe intraoperative or postoperative hemorrhage and 75 patients constituted matched controls. The incidence of probable type B viral hepatitis in patients receiving factor IX concentrate was 13.8 percent (four of 29) versus zero percent (zero of 29) in control patients (difference not significant). However, there was a greater incidence (p less than 0.05) of anti-HBs in patients receiving factor IX concentrate as compared to control subjects. No hepatitis-associated deaths or major morbidity were noted in these patients. It is confirmed that factor IX concentrate carries an associated significant risk of hepatitis. However, its use is justified in certain severe, acquired coagulopathies in which conventional platelet and fresh-frozen plasma therapy is inadequate.
本报告介绍了心脏外科手术患者使用凝血因子IX浓缩剂（Proplex）的临床经验及肝炎风险。75例患者因术中或术后严重出血接受了该浓缩剂治疗，75例患者作为匹配对照。接受凝血因子IX浓缩剂治疗的患者中可能的B型病毒性肝炎发病率为13.8%（29例中有4例），而对照患者为0%（29例中0例）（差异无统计学意义）。然而，与对照受试者相比，接受凝血因子IX浓缩剂治疗的患者中抗-HBs的发生率更高（p<0.05）。这些患者中未观察到与肝炎相关的死亡或严重并发症。已证实凝血因子IX浓缩剂存在显著的肝炎相关风险。然而，在某些严重的获得性凝血病中，当传统的血小板和新鲜冰冻血浆治疗不足时，使用它是合理的。
