Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children
Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children
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DOI：
10.1001/jama.279.10.756
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发表时间：
1998-03-11
影响因子：
120.7
通讯作者：
Baker, CJ
中科院分区：
文献类型：
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作者：
Palumbo, PE;Raskino, C;Baker, CJ
上下文。儿童人类免疫缺陷病毒（HIV）感染具有独特的病毒致病特征，无法从成人研究中进行常规推断，需要进行特定的分析。目的：评估血浆RNA和CD4（+）淋巴细胞计数这两个关键实验室标志物对婴儿和儿童HIV疾病进展的预后价值，并建立最佳结果的目标值。研究人员分析了566名参加核苷逆转录酶抑制剂（ACTG 152）随机、安慰剂对照试验的婴儿和儿童的数据。该试验于1991年至1995年进行，招募了一组未接受抗逆转录病毒治疗的儿童（3个月至18岁）；患者的中位随访时间为32个月。主要结果测量。-试验临床终点包括首次HIV疾病进展（生长衰竭、神经或神经发育功能下降、机会性感染）或死亡的时间。-基线血浆RNA水平高(年龄组中位数，5x10(4)至bbb10(6)拷贝/mL)，基线RNA和CD4（+）淋巴细胞计数均可独立预测随后的临床病程。基线RNA每减少对数（10），疾病进展风险降低49%至64%，呈线性，无阈值或年龄效应。联合使用血浆RNA和CD4（+）细胞计数可增强疾病进展预测能力，血浆RNA标记值小于10,000拷贝/mL和CD4（+）细胞计数标记值大于500 × 10(6)/L（6.5年）与2年疾病进展率小于5%相关。两个关键的实验室标志物——血浆RNA和CD4（+）淋巴细胞计数——是hiv感染婴儿和儿童临床病程的独立预测因子。log（10）血浆RNA与疾病进展的相对风险之间的线性、不依赖年龄的关系有力地支持了尽可能降低血浆病毒水平的治疗努力。
Context.-Pediatric human immunodeficiency virus (HIV) infection has unique viral pathogenetic features that preclude routine extrapolation from adult studies and require specific analysis.Objectives.-To evaluate the prognostic value of 2 key laboratory markers-plasma RNA and CD4(+) lymphocyte count-for HIV disease progression in infants and children and to establish targeted values for optimal outcome.Design.-Data from a cohort of 566 infants and children who participated in a randomized, placebo-controlled trial of nucleoside reverse transcriptase inhibitors (ACTG 152) were analyzed. The trial was conducted between 1991 and 1995 and enrolled a heterogenous cohort of antiretroviral therapy-naive children (age, 3 months to 18 years); patients had a median follow-up of 32 months.Main Outcome Measures.-The trial clinical end points consisted of time to first HIV disease progression (growth failure, decline in neurologic or neurodevelopmental function, opportunistic infections) or death.Results.-Baseline plasma RNA levels were high (age group medians, 5x10(4) to >10(6) copies/mL), and both baseline RNA and CD4(+) lymphocyte count were independently predictive of subsequent clinical course. Risk reduction for disease progression between 49% and 64% was observed for each log(10) reduction in baseline RNA and was linear without suggestion of a threshold or age effect. Disease progression predictive power was enhanced by the combined use of plasma RNA and CD4(+) cell count, Marker values of less than 10 000 copies/mL for plasma RNA and greater than 500 x 10(6)/L (6.5 years) for CD4(+) cell count were associated with a 2-year disease progression rate of less than 5%.Conclusions.-Two key laboratory markers-plasma RNA and CD4(+) lymphocyte count-are independent predictors of clinical course among HIV-infected infants and children. The linear, age-independent relationship between log(10) plasma RNA and relative risk of disease progression strongly supports therapeutic efforts to achieve plasma virus levels as low as possible.