Warrier I, Kasper C K, White G C, Shapiro A D, Bergman G E
Division of Hematology/Oncology, Wayne State University, Detroit, Michigan, USA.
Am J Hematol. 1995 May;49(1):92-4. doi: 10.1002/ajh.2830490117.
This report summarizes safety and efficacy information among patients treated with high doses (> 75 U/kg) of a monoclonal antibody-purified factor IX concentrate [coagulation factor IX (human) monoclonal antibody purified)] in two clinical trials. One hundred infusions of this factor IX concentrate at doses > 75 U/kg were administered to 35 patients, six of whom had experienced thrombotic complications during previous treatment with prothrombin complex concentrate. Hemostasis in all patients was rated as "excellent," and there were no thrombotic complications.
本报告总结了两项临床试验中接受高剂量（>75 U/kg）单克隆抗体纯化的凝血因子IX浓缩物[凝血因子IX（人）单克隆抗体纯化]治疗的患者的安全性和有效性信息。35例患者接受了100次剂量>75 U/kg的该凝血因子IX浓缩物输注，其中6例患者在先前接受凝血酶原复合物浓缩物治疗期间曾发生血栓形成并发症。所有患者的止血情况均被评为“优秀”，且未出现血栓形成并发症。
