J Acquir Immune Defic Syndr. 2007 Nov 1;46(3):275-8. doi: 10.1097/qai.0b013e3181514441.
A trial to evaluate the risks and benefits of initiation of antiretroviral therapy (ART) in patients with high CD4 count (eg, > or =500 cells/mm3), in comparison with deferral (eg, to <350 cells/mm3), merits consideration. Two issues for consideration in designing such a trial are the proportion of patients seen in clinics who present with high CD4 count and the time it will take for those randomized to deferring ART to reach a level where ART must be initiated. Among 13,572 patients in the UK CHIC Study presenting since 1996, 3631 (27%) had a count > or =500 cells/mm3. Among 4268 ART-naive patients with at least one CD4 count in the 500 to 650 cells/mm3 range, the median time to <350 cells/mm3 (or start of ART) was 2.5 years, with a range of 2.1 to 3.1 years depending on the analysis approach. Viral load at baseline was a strong predictor of the time taken for the CD4 count to reach <350 cells/mm3, with the median ranging from 0.7 years in those with viral load > or =500,000 copies/mL to 4.7 years in those with <1000 copies/mL. This provides timely background data on ART-naive patients seen in clinical practice to support design of a trial to compare immediate with deferred ART in people with high CD4 count.
与延迟治疗（如CD4细胞计数降至<350个细胞/mm³时）相比，评估CD4细胞计数较高（如≥500个细胞/mm³）的患者开始抗逆转录病毒治疗（ART）的风险和益处的试验值得考虑。设计此类试验时需考虑的两个问题是诊所中CD4细胞计数较高的患者比例，以及随机分配至延迟ART治疗的患者达到必须开始ART治疗水平所需的时间。在英国CHIC研究自1996年以来就诊的13572例患者中，3631例（27%）的CD4细胞计数≥500个细胞/mm³。在4268例从未接受过ART治疗且至少有一次CD4细胞计数在500至650个细胞/mm³范围内的患者中，CD4细胞计数降至<350个细胞/mm³（或开始ART治疗）的中位时间为2.5年，根据分析方法不同，范围在2.1至3.1年之间。基线病毒载量是CD4细胞计数降至<350个细胞/mm³所需时间的有力预测指标，病毒载量≥500000拷贝/mL的患者中位时间为0.7年，而病毒载量<1000拷贝/mL的患者中位时间为4.7年。这为临床实践中未接受过ART治疗的患者提供了及时的背景数据，以支持设计一项试验，比较CD4细胞计数较高的患者立即接受ART治疗与延迟治疗的效果。
