Parks W P, Parks E S, Fischl M A, Leuther M D, Allain J P, Nusinoff-Lehrman S, Barry D W, Makuch R W
Department of Pediatrics, University of Miami School of Medicine, FL 33136.
J Acquir Immune Defic Syndr (1988). 1988;1(2):125-30.
Two independent measures of human immunodeficiency virus type 1 (HIV-1) infection, virus isolation, and serum levels of p24 antigen were evaluated in a double-blind randomized clinical trial of the safety and efficacy of a nucleoside analogue, 3'-azido-3'-deoxythymidine (AZT) versus placebo in a single center. Pretreatment studies from 38 AIDS and AIDS-related complex (ARC) patients were comparably positive for virus isolation from their lymphocytes; all patients were qualitatively virus positive. Before AZT treatment, there was significantly decreased virus recovery in patients with higher numbers of CD4-positive lymphocytes. Within 1 month of AZT therapy, the time in culture required to register virus positivity was increased markedly in the AZT-treated group, and over the following several months progressive diminution in virus recovery was noted. Similar changes were not seen in patients concurrently receiving placebo treatment. Before treatment, 16 of 20 and 12 of 16 patients in the AZT and placebo groups, respectively, were p24 antigen positive. Marked reduction in serum p24 levels were noted in 11 of 16 (69%) of the p24 antigen-positive AZT-treated patients compared to 3 of 12 (25%) of the p24 antigen-positive placebo-treated patients (p = 0.02). There was a marked virologic response in 14 of 20 (70%) of the AZT-treated patients compared to 4 of 18 (22%) placebo-treated patients (p = 0.004). A higher frequency of positive clinical and immunological effects also were noted in the AZT-treated patients relative to placebo-treated patients (p = 0.02 and p = 0.06, respectively).
在一个单中心进行的双盲随机临床试验中，对两种独立的人类免疫缺陷病毒1型（HIV-1）感染测量方法、病毒分离以及p24抗原的血清水平进行了评估，该试验旨在研究核苷类似物3'-叠氮-3'-脱氧胸苷（AZT）与安慰剂相比的安全性和有效性。来自38名艾滋病和艾滋病相关综合征（ARC）患者的预处理研究显示，从他们的淋巴细胞中分离病毒的结果相当阳性；所有患者在定性上均为病毒阳性。在接受AZT治疗前，CD4阳性淋巴细胞数量较多的患者中病毒回收率显著降低。在AZT治疗的1个月内，AZT治疗组中记录到病毒阳性所需的培养时间显著增加，并且在接下来的几个月中，病毒回收率逐渐下降。同时接受安慰剂治疗的患者未观察到类似变化。治疗前，AZT组20名患者中有16名、安慰剂组16名患者中有12名p24抗原呈阳性。与p24抗原呈阳性的安慰剂治疗患者中12名中的3名（25%）相比，p24抗原呈阳性的AZT治疗患者中16名中的11名（69%）血清p24水平显著降低（p = 0.02）。与18名安慰剂治疗患者中的4名（22%）相比，20名AZT治疗患者中的14名（70%）有明显的病毒学反应（p = 0.004）。相对于安慰剂治疗患者，AZT治疗患者中临床和免疫学阳性效应的频率也更高（分别为p = 0.02和p = 0.06）。
