Creagh-Kirk T, Doi P, Andrews E, Nusinoff-Lehrman S, Tilson H, Hoth D, Barry D W
Burroughs Wellcome Co. Research Triangle Park, NC 27709.
JAMA. 1988 Nov 25;260(20):3009-15.
Through a compassionate plea program (Treatment Investigational New Drug), 4805 patients with acquired immunodeficiency syndrome who previously had experienced Pneumocystis carinii pneumonia (PCP) received zidovudine (Retrovir, formerly azidothymidine). Overall survival at 44 weeks after initiation of therapy was 73% (+/- 2.1%). A positive association was found between survival and pretherapy clinical status as defined by hemoglobin level, functional ability, and stage of disease as measured by time since diagnosis of PCP. For patients with baseline hemoglobin levels of 120 g/L or greater, Karnofsky scores of 90 or greater, and PCP diagnosis within 90 days prior to initiation of therapy, 44-week survival was 88%. Adverse clinical experiences associated with zidovudine therapy were consistent with those from a double-blind, placebo-controlled trial. Survival experience of this large and diverse cohort is consistent with, and extends data from, this clinical trial. Comparison with available natural history data suggests that zidovudine therapy is associated with increased 44-week survival of post-PCP patients with acquired immunodeficiency syndrome.
通过一项同情用药计划(治疗性研究新药),4805例曾患卡氏肺孢子虫肺炎(PCP)的获得性免疫缺陷综合征患者接受了齐多夫定(叠氮胸苷,商品名:Retrovir)治疗。治疗开始后44周的总生存率为73%(±2.1%)。研究发现,生存率与治疗前临床状况呈正相关,治疗前临床状况由血红蛋白水平、功能能力以及自PCP诊断以来的疾病分期来定义。对于基线血红蛋白水平≥120 g/L、卡氏评分≥90且在治疗开始前90天内诊断为PCP的患者,44周生存率为88%。与齐多夫定治疗相关的不良临床经验与双盲、安慰剂对照试验的结果一致。这个规模庞大且多样化队列的生存经验与该临床试验的数据一致,并扩展了相关数据。与现有的自然史数据比较表明,齐多夫定治疗可提高PCP后获得性免疫缺陷综合征患者44周的生存率。