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M9630174.TXT
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1996-02-27
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Document 0174
DOCN M9630174
TI Thalidomide treatment reduces tumor necrosis factor alpha production and
enhances weight gain in patients with pulmonary tuberculosis.
DT 9603
AU Tramontana JM; Utaipat U; Molloy A; Akarasewi P; Burroughs M;
Makonkawkeyoon S; Johnson B; Klausner JD; Rom W; Kaplan G; Laboratory of
Cellular Physiology and Immunology, Rockefeller; University, New York,
NY 10021, USA.
SO Mol Med. 1995 May;1(4):384-97. Unique Identifier : AIDSLINE MED/96091362
AB BACKGROUND: The monocyte-derived cytokine, tumor necrosis factor alpha
(TNF alpha), is essential for host immunity, but overproduction of this
cytokine may have serious pathologic consequences. Excess TNF alpha
produced in pulmonary tuberculosis may cause fevers, weakness, night
sweats, necrosis, and progressive weight loss. Thalidomide
(alpha-N-phthalimidoglutarimide) has recently been shown to suppress TNF
alpha production by human monocytes in vitro and to reduce serum TNF
alpha in leprosy patients. We have therefore conducted a two-part
placebo-controlled pilot study of thalidomide in patients with active
tuberculosis to determine its effects on clinical response, immune
reactivity, TNF alpha levels, and weight. MATERIALS AND METHODS: 30 male
patients with active tuberculosis, either human immunodeficiency virus
type 1 positive (HIV-1+) or HIV-1-, received thalidomide or placebo for
single or multiple 14 day cycles. Toxicity of the study drug, delayed
type hypersensitivity (DTH), cytokine production, and weight gain were
evaluated. RESULTS: Thalidomide treatment was well tolerated, without
serious adverse events. The drug did not adversely affect the DTH
response to purified protein derivative (PPD), total leukocyte, or
differential cell counts. TNF alpha production was significantly reduced
during thalidomide treatment while interferon-gamma (IFN gamma)
production was enhanced. Daily administration of thalidomide resulted in
a significant enhancement of weight gain. CONCLUSIONS: The results
indicate that thalidomide is well tolerated by patients receiving
anti-tuberculosis therapy. Thalidomide treatment reduces TNF alpha
production both in vivo and in vitro and is associated with an
accelerated weight gain during the study period.
DE Adult Aged Cells, Cultured Cytokines/BIOSYNTHESIS Human
Hypersensitivity, Delayed/CHEMICALLY INDUCED Immunosuppressive
Agents/ADVERSE EFFECTS/*THERAPEUTIC USE Leukocytes,
Mononuclear/METABOLISM Male Middle Age Pilot Projects Support,
Non-U.S. Gov't Support, U.S. Gov't, P.H.S. Thalidomide/ADVERSE
EFFECTS/*THERAPEUTIC USE Tuberculosis, Pulmonary/*DRUG
THERAPY/METABOLISM/PHYSIOPATHOLOGY Tumor Necrosis Factor/ANTAGONISTS &
INHIB/*BIOSYNTHESIS Weight Gain/DRUG EFFECTS CLINICAL TRIAL JOURNAL
ARTICLE
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).