Document Detail

Effects of N-acetylcysteine on dense cell formation in sickle cell disease.
MedLine Citation:
PMID:  12701116     Owner:  NLM     Status:  MEDLINE    
The extent to which dense and irreversible sickle cells (ISCs) contribute to vaso-occlusive episodes in sickle cell disease remains unclear. N-Acetylcysteine (NAC) inhibits dense cell and ISC formation in sickle erythrocytes in vitro and restores glutathione levels toward normal. A phase II double-blind randomized clinical trial was completed to determine the efficacy of NAC in decreasing dense cell and ISC formation, and vaso-occlusive episodes in sickle cell disease. Twenty-one subjects with a history of at least two vaso-occlusive episodes per year and 6% dense cells were enrolled. Four treatment groups were analyzed; NAC at a dose of 2,400 mg per day decreased the percent dense cells from 20.1 +/- 2.9 to 12.6 +/- 2.1 (P < 0.05) and increased red cell glutathione levels from 292.8 +/- 74.5 to 576.7 +/- 155.1 (P < 0.05). In addition, we observed a decrease in vaso-occlusive episodes from 0.03 to 0.006 episodes per person-days and a decreased in relative risk to R = 0.39. Although NAC did not significantly decrease the number of ISCs, there was a downward trend at all doses tested. In summary, NAC inhibited dense cell formation, restored glutathione levels toward normal, and decreased vaso-occlusive episodes at a well-tolerated dose of 2,400 mg per day. To determine the long-term efficacy and safety of NAC, a multicenter phase III clinical trial is required.
Betty S Pace; Archil Shartava; Ardie Pack-Mabien; Mudhari Mulekar; Alfredo Ardia; Steven R Goodman
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  American journal of hematology     Volume:  73     ISSN:  0361-8609     ISO Abbreviation:  Am. J. Hematol.     Publication Date:  2003 May 
Date Detail:
Created Date:  2003-04-17     Completed Date:  2003-05-16     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  7610369     Medline TA:  Am J Hematol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  26-32     Citation Subset:  IM    
Copyright Information:
Copyright 2003 Wiley-Liss, Inc.
Department of Molecular and Cell Biology, University of Texas at Dallas, 2601 Floyd Road, Mail Station FO 3.1, Richardson, TX 75083, USA.
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MeSH Terms
Acetylcysteine / blood,  therapeutic use*
Anemia, Sickle Cell / blood*,  complications,  drug therapy*
Double-Blind Method
Erythrocytes, Abnormal / chemistry,  pathology*
Glutathione / blood
Vascular Diseases / etiology,  prevention & control
Grant Support
Reg. No./Substance:
0/Placebos; 616-91-1/Acetylcysteine; 70-18-8/Glutathione

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