Wagner N, Bialek R, Radinger H, Brackmann H H, Becker M
Department of Paediatrics, University of Bonn, Federal Republic of Germany.
Arch Dis Child. 1992 Oct;67(10):1267-71. doi: 10.1136/adc.67.10.1267.
In order to evaluate the efficacy of intravenous immunoglobulin (IVIG) in the early stages of HIV infection (patients without AIDS or AIDS related complex) a prospective controlled open trial was conducted in 36 patients (age 6-19 years) with haemophilia. Eighteen patients received 0.3 g/kg IVIG at two week intervals; 18 patients served as controls. Major criteria for the evaluation were progression of HIV disease assessed by the modified Brodt/Helm classification, number of infectious events and HIV associated thrombocytopenia, and the CD4+ T cell count. After 24 months of evaluation seven patients in the IVIG group and five patients in the control group deteriorated according to their staging, with one patient in each group developing AIDS. Thrombocytopenia and infectious events, but no severe bacterial infections, occurred in both groups in similar numbers. The absolute CD4+ T cell count decreased by 284/microliters in the IVIG group and by 143/microliters in the control group respectively (mean values). The statistical analysis of these criteria did not reveal any significant difference. In conclusion, IVIG was not effective in the early stages of HIV infection in patients with haemophilia. IVIG did not slow down the progression of HIV disease and did not prevent the development of an immunodeficiency as assessed by the CD4+ T cell count.
为了评估静脉注射免疫球蛋白(IVIG)在HIV感染早期阶段(无艾滋病或艾滋病相关综合征的患者)的疗效,对36例年龄在6至19岁的血友病患者进行了一项前瞻性对照开放试验。18例患者每隔两周接受0.3 g/kg的IVIG治疗;18例患者作为对照。评估的主要标准包括通过改良的布罗特/赫尔姆分类法评估的HIV疾病进展、感染事件的数量和HIV相关血小板减少症,以及CD4 + T细胞计数。经过24个月的评估,IVIG组有7例患者、对照组有5例患者根据其分期病情恶化,每组各有1例患者发展为艾滋病。两组中血小板减少症和感染事件的发生数量相似,但均未出现严重细菌感染。IVIG组的绝对CD4 + T细胞计数平均下降了284/微升,对照组平均下降了143/微升。对这些标准的统计分析未发现任何显著差异。总之,IVIG对血友病患者HIV感染的早期阶段无效。IVIG并未减缓HIV疾病的进展,也未通过CD4 + T细胞计数评估来预防免疫缺陷的发展。