Eller Leigh Anne, Eller Michael A, Ouma Benson, Kataaha Peter, Kyabaggu Denis, Tumusiime Richard, Wandege Joseph, Sanya Ronald, Sateren Warren B, Wabwire-Mangen Fred, Kibuuka Hannah, Robb Merlin L, Michael Nelson L, de Souza Mark S
U.S. Military HIV Research Program, Rockville, Maryland, United States of America.
PLoS One. 2008;3(12):e3919. doi: 10.1371/journal.pone.0003919. Epub 2008 Dec 11.
Clinical trials are increasingly being conducted internationally. In order to ensure enrollment of healthy participants and proper safety evaluation of vaccine candidates, established reference intervals for clinical tests are required in the target population.
METHODOLOGY/PRINCIPAL FINDINGS: We report a reference range study conducted in Ugandan adult blood bank donors establishing reference intervals for hematology and clinical chemistry parameters. Several differences were observed when compared to previously established values from the United States, most notably in neutrophils and eosinophils.
CONCLUSIONS/SIGNIFICANCE: In a recently conducted vaccine trial in Uganda, 31 percent (n = 69) of volunteers screened (n = 223) were excluded due to hematologic abnormalities. If local reference ranges had been employed, 83% of those screened out due to these abnormalities could have been included in the study, drastically reducing workload and cost associated with the screening process. In addition, toxicity tables used in vaccine and drug trial safety evaluations may need adjustment as some clinical reference ranges determined in this study overlap with grade 1 and grade 2 adverse events.
临床试验越来越多地在国际范围内开展。为确保纳入健康参与者并对候选疫苗进行适当的安全性评估，目标人群需要有既定的临床检测参考区间。
方法/主要发现：我们报告了一项在乌干达成年血库献血者中进行的参考范围研究，该研究确定了血液学和临床化学参数的参考区间。与美国先前确定的值相比，观察到了一些差异，最明显的是中性粒细胞和嗜酸性粒细胞。
结论/意义：在乌干达最近进行的一项疫苗试验中，筛查的志愿者（n = 223）中有31%（n = 69）因血液学异常被排除。如果采用当地的参考范围，因这些异常被筛出的人中83%本可纳入研究，这将大幅减少与筛查过程相关的工作量和成本。此外，疫苗和药物试验安全性评估中使用的毒性表可能需要调整，因为本研究确定的一些临床参考范围与1级和2级不良事件重叠。
