Hay C R, Lozier J N, Lee C A, Laffan M, Tradati F, Santagostino E, Ciavarella N, Schiavoni M, Fukui H, Yoshioka A, Teitel J, Mannucci P M, Kasper C K
University Dept of Haematology, Royal Liverpool University Hospital, UK.
Thromb Haemost. 1996 Jan;75(1):25-9.
A multicentre retrospective survey was conducted to re-assess the use of porcine factor VIII (HYATE:C), its side effects and the selection of patients for regular or home-therapy. 15,152,000 units of HYATE:C were used by 154 patients. The median inhibitor cross-reactivity to porcine VIIIC of 137 patients was 15%, 27% of patients lacking cross-reactivity. An absent, intermediate or brisk specific antiporcine anamnestic response was observed in 29, 40 and 31% of patients respectively. Seven patients were treated on-demand as home-therapy for a median 6.2, range 1.5-13 years, 23 further patients were treated regularly in hospital for a median of 3, range 2-7 years. This group used 8,319,000 U of porcine VIIIC for 2,000 bleeding episodes. The incidence of transfusion reactions was 0.001%, 0.64% and 2.3%, for domiciliary infusions, infusions in multiply treated in-patients, and unselected in-patient infusions, respectively. The risk of reactions was dose-related. A post-infusion fall in platelet count was common, but usually transient and clinically insignificant. This was also dose-related (r = -0.64, p = 0.002). Marked reductions in platelet count were occasionally seen, usually with intensive replacement therapy. The relative lack of side effects observed amongst patients treated at home is attributable to the low, median 33 U/kg, dose used by this group. A subgroup of inhibitor patients, identifiable by their absent or modest anamnestic response to porcine factor VIII may be treated regularly and safely with this product in small doses, over a period of years.
开展了一项多中心回顾性调查，以重新评估猪源因子VIII（HYATE:C）的使用情况、其副作用以及适合定期治疗或家庭治疗的患者选择。154例患者使用了15,152,000单位的HYATE:C。137例患者对猪源VIIIC的抑制剂交叉反应性中位数为15%，27%的患者缺乏交叉反应性。分别在29%、40%和31%的患者中观察到无、中等或强烈的特异性抗猪源回忆反应。7例患者按需接受家庭治疗，中位数为6.2年，范围为1.5 - 13年，另有23例患者在医院接受定期治疗，中位数为3年，范围为2 - 7年。该组使用8,319,000单位猪源VIIIC治疗了2000次出血事件。家庭输注、多次治疗的住院患者输注和未选择的住院患者输注的输血反应发生率分别为0.001%、0.64%和2.3%。反应风险与剂量相关。输注后血小板计数下降很常见，但通常是短暂的且临床意义不大。这也与剂量相关（r = -0.64，p = 0.002）。偶尔会出现血小板计数显著下降，通常发生在强化替代治疗时。在家治疗的患者中观察到相对较少的副作用，这归因于该组使用的剂量较低，中位数为33 U/kg。对于对猪源因子VIII无或仅有适度回忆反应的抑制剂患者亚组，可以在数年内小剂量、定期且安全地使用该产品进行治疗。
