Document Detail


Hematologic and immunologic parameters in Zimbabwean infants: a case for using local reference intervals to monitor toxicities in clinical trials.
MedLine Citation:
PMID:  21504989     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Stephanie B Troy; Ali Rowhani-Rahbar; LauraLe Dyner; Georgina Musingwini; Avinash K Shetty; Godfrey Woelk; Lynda Stranix-Chibanda; Kusum Nathoo; Yvonne A Maldonado
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, N.I.H., Extramural     Date:  2011-04-18
Journal Detail:
Title:  Journal of tropical pediatrics     Volume:  58     ISSN:  1465-3664     ISO Abbreviation:  J. Trop. Pediatr.     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-01-25     Completed Date:  2012-05-31     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  8010948     Medline TA:  J Trop Pediatr     Country:  England    
Other Details:
Languages:  eng     Pagination:  59-62     Citation Subset:  IM    
Affiliation:
Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA 94305-5208, USA. sbtroy@stanford.edu
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MeSH Terms
Descriptor/Qualifier:
Chi-Square Distribution
Female
HIV Seronegativity
Hematologic Tests / standards*
Humans
Immunologic Tests / standards*
Infant
Male
Monitoring, Physiologic / methods*
Prospective Studies
Reference Values
Statistics, Nonparametric
Zimbabwe
Grant Support
ID/Acronym/Agency:
R01 AI068577/AI/NIAID NIH HHS
Comments/Corrections

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