Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA 94305-5208, USA.
J Trop Pediatr. 2012 Feb;58(1):59-62. doi: 10.1093/tropej/fmr031. Epub 2011 Apr 18.
Studies investigating novel therapies in African infants report laboratory adverse events based on reference intervals from white Western infants. However, prior studies have shown that reference intervals differ based on ethnicity and geographic location. We calculated reference intervals for Zimbabwean infants by analyzing the hematologic and immunologic values found in 542 blood samples from 269 HIV-uninfected, black, Zimbabwean infants at 3, 5 and 9 months of age. Substantial proportions of the platelet counts (44%), hemoglobins (19%) and mean corpuscular volumes (41%) were outside published normal ranges. The majority (65%) of hemoglobin values qualified as a United States National Institutes of Health Division of AIDS adverse events. The majority (71%) of CD4% values indicated immunodeficiency by World Health Organization criteria. Hematologic and immunologic reference intervals used to evaluate toxicities in pediatric trials in sub-Saharan Africa need to be reevaluated to account for differences in ethnicity, geographic location, nutrition and socioeconomic status.
研究报告表明，在针对非洲婴儿的新型疗法研究中，实验室不良事件是基于来自白种西方婴儿的参考区间得出的。然而，先前的研究表明，参考区间因种族和地理位置的不同而有所差异。我们通过分析来自 269 名未感染艾滋病毒的黑人津巴布韦婴儿的 542 份血液样本中的血液学和免疫学值，计算了津巴布韦婴儿的参考区间。血小板计数（44%）、血红蛋白（19%）和平均红细胞体积（41%）的相当大比例均超出了已公布的正常范围。大多数（65%）的血红蛋白值符合美国国立卫生研究院艾滋病分部的不良事件标准。根据世界卫生组织的标准，大多数（71%）的 CD4%值表明免疫功能缺陷。在撒哈拉以南非洲进行儿科试验中，用于评估毒性的血液学和免疫学参考区间需要重新评估，以考虑到种族、地理位置、营养和社会经济地位的差异。
