Gjerset G F, Pike M C, Mosley J W, Hassett J, Fletcher M A, Donegan E, Parker J W, Counts R B, Zhou Y, Kasper C K
Puget Sound Blood Center, Seattle, WA.
Blood. 1994 Sep 1;84(5):1666-71.
Low- and intermediate-purity clotting-factor therapies are believed to accelerate human immunodeficiency virus (HIV) progression in hemophiliacs through adverse immune effects of the other plasma proteins in the preparations. To investigate this postulate, we evaluated data from six clinical centers that observed persons with congenital factor deficiencies at 6-month intervals. The present analysis is based on HIV-infected subjects who received intermediate purity factor VIII or factor IX concentrates, or cryoprecipitate. For long-term outcome, we classified 374 subjects by the type and amount of treatment during our first year of observation, and determined the subsequent rate of progression to a CD4 count less than 200 cells/microL. A second analysis of this group used a repeated-measures, random-effect model that allowed for individual differences in CD4 decline. Finally, we compared short-term rates of change in CD4 count in each treatment interval of 525 subjects with the type and amount of factor therapy received in the same interval. There was no overall or dose-related deleterious effect of any form of treatment on CD4 trend. The CD4 decrease was less when cryoprecipitate was administered alone or combined with concentrate, but not significantly so. Our results counter the assertion that low- and intermediate-purity products accelerate the rate of CD4 decrease in HIV-1-infected hemophiliacs.
低纯度和中等纯度的凝血因子疗法被认为会通过制剂中其他血浆蛋白的不良免疫作用,加速血友病患者体内人类免疫缺陷病毒(HIV)的病情发展。为了研究这一假设,我们评估了六个临床中心的数据,这些中心每隔6个月对先天性因子缺乏症患者进行观察。目前的分析基于感染HIV的受试者,他们接受了中等纯度的凝血因子VIII或IX浓缩物,或冷沉淀治疗。对于长期结果,我们在观察的第一年根据治疗类型和剂量对374名受试者进行了分类,并确定了随后CD4细胞计数降至低于200个/微升的进展率。对该组的第二项分析使用了重复测量随机效应模型,该模型考虑了CD4下降的个体差异。最后,我们比较了525名受试者在每个治疗间隔期内CD4细胞计数的短期变化率与同期接受的凝血因子治疗的类型和剂量。任何形式的治疗对CD4趋势均无总体或剂量相关的有害影响。单独使用冷沉淀或与浓缩物联合使用时,CD4的下降较少,但差异不显著。我们的结果反驳了低纯度和中等纯度产品会加速HIV-1感染血友病患者CD4下降速度的说法。