Palumbo P E, Raskino C, Fiscus S, Pahwa S, Schutzbank T, Spector S A, Baker C J, Englund J A
Department of Pediatrics, University of Medicine and Dentistry of New Jersey, Newark, NJ 07103, USA.
J Infect Dis. 1999 Mar;179(3):576-83. doi: 10.1086/314638.
Plasma human immunodeficiency virus RNA and CD4 lymphocyte response to nucleoside reverse-transcriptase therapy were evaluated in a large, comparative pediatric trial. Both baseline values and changes in the two laboratory markers over time correlated well with clinical outcome and possessed independent predictive value. In comparison of RNA reduction from baseline between the dideoxyinosine (ddI) and zidovudine+ddI therapeutic arms, marginal superiority of the combination arm was not correlated with an observed clinical benefit. Despite the size of this trial and the significantly higher rate of clinical end points in the zidovudine monotherapy group, attempts to establish surrogacy for plasma RNA were difficult. Nevertheless, plasma RNA and CD4 lymphocyte count together possess strong clinical predictive power and are valuable tools for both the clinician and the evaluation of new therapies.
在一项大型儿科对照试验中，对血浆人类免疫缺陷病毒RNA以及核苷类逆转录酶疗法治疗后的CD4淋巴细胞反应进行了评估。两个实验室指标的基线值及其随时间的变化均与临床结果密切相关，并具有独立的预测价值。在比较去羟肌苷（ddI）治疗组与齐多夫定+ddI联合治疗组相对于基线的RNA降低情况时，联合治疗组的微弱优势与所观察到的临床获益并无关联。尽管该试验规模较大，且齐多夫定单药治疗组的临床终点发生率显著更高，但要确定血浆RNA作为替代指标仍很困难。然而，血浆RNA和CD4淋巴细胞计数共同具有强大的临床预测能力，对于临床医生和新疗法评估而言都是有价值的工具。
