| A randomized phase II trial of Arginine Butyrate with standard local therapy in refractory sickle cell leg ulcers. | |
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MedLine Citation:
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PMID: 20955402 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Sickle cell leg ulcers are often debilitating, refractory to healing, and prone to recurrence. Healing of leg ulcers was incidentally observed during dose-ranging trials of Arginine Butyrate in beta haemoglobinopathies. Here, a controlled Phase II trial was performed in sickle cell patients who had lower extremity ulcers refractory to standard care for at least 6 months. Patients were randomized to receive standard local care alone (Control Arm) or standard care with Arginine Butyrate administered 5 d/week (Treatment Arm), for 12 weeks. Ulcers were photographed weekly, traced, and ulcer areas were calculated by computerized planimetry and compared between the two study arms. Twenty-seven study courses were evaluated. Control Arm subjects had 25 ulcers with a mean area of 25·7 cm(2) initially and 23·2 cm(2) after 12 weeks; 2/25 (8%) healed completely. Treatment Arm subjects had 37 ulcers with a mean area of 50·6 cm(2) initially and 28·3 cm(2) at 12 weeks; 11/37 of these (30%) healed completely. After 3 months, proportions of ulcers which healed were 6/25 (24%) and 29/37 (78%), in the Control and Treatment Arms respectively (P < 0·001). These findings strongly suggest that Arginine Butyrate merits further evaluation for the treatment of refractory sickle cell leg ulcers in larger trials. |
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Authors:
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Lillian McMahon; Hannah Tamary; Melissa Askin; Patricia Adams-Graves; Robert T Eberhardt; Millicent Sutton; Elizabeth C Wright; Serguei A Castaneda; Douglas V Faller; Susan P Perrine |
Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S. Date: 2010-10-19 |
Journal Detail:
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Title: British journal of haematology Volume: 151 ISSN: 1365-2141 ISO Abbreviation: Br. J. Haematol. Publication Date: 2010 Dec |
Date Detail:
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Created Date: 2010-11-12 Completed Date: 2011-01-03 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372544 Medline TA: Br J Haematol Country: England |
Other Details:
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Languages: eng Pagination: 516-24 Citation Subset: IM |
Copyright Information:
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© 2010 Blackwell Publishing Ltd. |
Affiliation:
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Cancer Center and Hemoglobinopathy Thalassemia Research Unit, Boston University School of Medicine, Boston, MA 02118, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anemia, Sickle Cell / complications* Arginine / analogs & derivatives*, therapeutic use Butyrates / therapeutic use* Chronic Disease Female Humans Leg Ulcer / drug therapy*, etiology, pathology Male Middle Aged Prospective Studies Treatment Outcome Wound Healing / drug effects Young Adult |
| Grant Support | |
ID/Acronym/Agency:
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FD-R-000176/FD/FDA HHS; M01 RR00533/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Butyrates; 74-79-3/Arginine; 80407-72-3/arginine butyrate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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