Schwartz R S, Ewing N P, Gorenc T J, Spero J A
Department of Clinical Research, Cutter Biological, Miles Inc., Berkeley, CA 94710.
Am J Hematol. 1989 Jan;30(1):22-6. doi: 10.1002/ajh.2830300105.
To determine if heat-treated factor IX complex concentrate is as effective as nonheated factor IX complex concentrate for treatment of subjects with hemophilia A and antifactor VIII antibodies (inhibitor patients), we have retrospectively reviewed consecutive home treatment records of ten inhibitor patients who had been receiving nonheat-treated factor IX complex concentrate (NHT-Konyne) and subsequently converted to heat-treated factor complex concentrate (Konyne-HT) when it was licensed in late 1984. Overall, 162 of 284 (57%) separate bleeding episodes treated with NHT-Konyne and 53 of 80 (66.3%) separate bleeding episodes treated with Konyne-HT required only one treatment course of approximately 60-75 U/kg. The distribution of bleeding sites and the absolute factor IX unitage required per treatment episode were similar for both preparations. These data suggest that the percentage of hemophilic inhibitor patients responding to factor IX complex concentrate remains at least 50%, as was reported several years ago in a controlled study, and that inhibitor bypass activity has not altered by heat treatment.
为了确定热处理的凝血因子IX复合物浓缩剂对于治疗甲型血友病和抗凝血因子VIII抗体患者（抑制物患者）是否与未加热的凝血因子IX复合物浓缩剂同样有效，我们回顾性地查阅了10例抑制物患者的连续家庭治疗记录，这些患者此前一直接受未热处理的凝血因子IX复合物浓缩剂（NHT-Konyne）治疗，1984年末热处理的凝血因子复合物浓缩剂（Konyne-HT）获批后转而接受该药物治疗。总体而言，接受NHT-Konyne治疗的284次独立出血事件中有162次（57%），接受Konyne-HT治疗的80次独立出血事件中有53次（66.3%）仅需约60 - 75 U/kg的一个疗程治疗。两种制剂的出血部位分布以及每次治疗事件所需的凝血因子IX绝对单位量相似。这些数据表明，对凝血因子IX复合物浓缩剂有反应的血友病抑制物患者比例至少仍为50%，这与几年前一项对照研究中的报告一致，并且热处理并未改变抑制物旁路活性。
