Abstract | BACKGROUND: In patients with advanced human immunodeficiency virus ( HIV) infection, aphthous ulceration of the mouth and oropharynx can become extensive and debilitating. Preliminary reports suggest that thalidomide may promote the healing of oral aphthous ulcers. METHODS: RESULTS: Sixteen of 29 patients in the thalidomide group (55 percent) had complete healing of their aphthous ulcers after four weeks, as compared with only 2 of 28 patients in the placebo group (7 percent; odds ratio, 15; 95 percent confidence interval after adjustment for group sequential testing, 1.8 to 499; unadjusted P<0.001). Pain diminished and ability to eat improved with thalidomide treatment. The adverse effects noted with thalidomide included somnolence and rash (7 patients each), and 6 of the 29 patients discontinued treatment because of toxicity. Thalidomide treatment increased HIV RNA levels (median increase, 0.42 log10 copies per milliliter; increase with placebo, 0.05; P=0.04). With thalidomide treatment there were unexpected increases in the plasma concentrations of TNF-alpha and soluble TNF-alpha receptors. CONCLUSIONS:
Thalidomide is an effective treatment for aphthous ulceration of the mouth and oropharynx in patients with HIV infection.
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Authors | J M Jacobson, J S Greenspan, J Spritzler, N Ketter, J L Fahey, J B Jackson, L Fox, M Chernoff, A W Wu, L A MacPhail, G J Vasquez, D A Wohl |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 336
Issue 21
Pg. 1487-93
(May 22 1997)
ISSN: 0028-4793 [Print] United States |
PMID | 9154767
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Receptors, Tumor Necrosis Factor
- Tumor Necrosis Factor-alpha
- Thalidomide
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Topics |
- Acquired Immunodeficiency Syndrome
(complications)
- Adult
- Double-Blind Method
- Female
- HIV-1
(drug effects, isolation & purification)
- Humans
- Male
- Quality of Life
- Receptors, Tumor Necrosis Factor
(blood)
- Stomatitis, Aphthous
(drug therapy, etiology)
- Thalidomide
(adverse effects, therapeutic use)
- Treatment Outcome
- Tumor Necrosis Factor-alpha
(analysis)
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