Schmitt F A, Bigley J W, McKinnis R, Logue P E, Evans R W, Drucker J L
Department of Neurology, University of Kentucky Medical Center, Lexington 40536-0084.
N Engl J Med. 1988 Dec 15;319(24):1573-8. doi: 10.1056/NEJM198812153192404.
Two hundred eighty-one patients with the acquired immunodeficiency syndrome (AIDS) or advanced AIDS-related complex were enrolled in a double-blind, placebo-controlled trial of the efficacy and safety of orally administered zidovudine (azidothymidine or AZT). Significant clinical benefits and adverse experiences have been reported from this trial. Because neuropsychiatric dysfunction is often associated with human immunodeficiency virus (HIV) infection, a brief affective and neuropsychological examination was administered over 16 weeks of the trial to evaluate any changes in neuropsychological function that occurred with drug administration. Patients receiving zidovudine, particularly those with AIDS, showed improved cognition as compared with patients receiving placebo. There were no changes in affective symptoms. The zidovudine recipients also had a statistically significant reduction in the intensity of symptomatic distress during the trial that may account in part for the observed cognitive changes. Some improvement in various cognitive measures was also seen in patients with AIDS-related complex. The results of this study suggest HIV-associated cognitive abnormalities may be partially ameliorated after the administration of zidovudine.
281例获得性免疫缺陷综合征(AIDS)或晚期AIDS相关综合征患者参与了一项关于口服齐多夫定(叠氮胸苷或AZT)疗效和安全性的双盲、安慰剂对照试验。该试验已报告了显著的临床益处和不良事件。由于神经精神功能障碍常与人类免疫缺陷病毒(HIV)感染相关,因此在试验的16周内进行了简短的情感和神经心理学检查,以评估药物治疗过程中神经心理功能的任何变化。与接受安慰剂的患者相比,接受齐多夫定治疗的患者,尤其是患有AIDS的患者,认知功能有所改善。情感症状没有变化。在试验期间,接受齐多夫定治疗的患者症状困扰强度在统计学上也有显著降低,这可能部分解释了观察到的认知变化。患有AIDS相关综合征的患者在各种认知指标上也有一些改善。这项研究的结果表明,服用齐多夫定后,HIV相关的认知异常可能会得到部分改善。