DeGruttola V, Beckett L A, Coombs R W, Arduino J M, Balfour H H, Rasheed S, Hollinger F B, Fischl M A, Volberding P
Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts.
J Infect Dis. 1994 Apr;169(4):713-21. doi: 10.1093/infdis/169.4.713.
Serum p24 antigen levels were examined in subjects from three clinical trials of zidovudine to determine whether the pattern of change in serum p24 antigen during the first 8-16 weeks of therapy was associated with human immunodeficiency virus type 1 (HIV-1) disease progression or death. Among 406 patients with AIDS and a first episode of Pneumocystis carinii pneumonia, 65% had measurable pretreatment concentrations of serum p24 antigen (> or = 10 pg/mL). Changes during treatment were not associated with reduced mortality. In 637 mildly symptomatic patients, 24% had measurable concentrations, and changes were marginally associated with increased time until more advanced disease. Among 683 asymptomatic patients, 18% had measurable concentrations, and changes were not associated with increased time until progression. Despite the small number of clinical events and the low rate of serum p24 antigen positivity in the latter two studies, pretreatment serum p24 antigen levels were predictive of clinical outcome; subsequent measurements appear to be of limited use in evaluating zidovudine therapy.
在三项齐多夫定临床试验的受试者中检测了血清p24抗原水平，以确定治疗开始后的8 - 16周内血清p24抗原的变化模式是否与1型人类免疫缺陷病毒（HIV-1）疾病进展或死亡相关。在406例患有艾滋病且首次发生卡氏肺孢子虫肺炎的患者中，65%的患者治疗前血清p24抗原浓度可检测到（≥10 pg/mL）。治疗期间的变化与死亡率降低无关。在637例症状轻微的患者中，24%的患者浓度可检测到，且变化与疾病进展至更严重阶段的时间延长略有相关。在683例无症状患者中，18%的患者浓度可检测到，且变化与疾病进展前的时间延长无关。尽管后两项研究中的临床事件数量较少且血清p24抗原阳性率较低，但治疗前血清p24抗原水平可预测临床结局；后续测量在评估齐多夫定治疗方面似乎用处有限。
