TY - JOUR
T1 - Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection
AU - Jacobson, Jeffrey M.
AU - Greenspan, John S.
AU - Spritzler, John
AU - Ketter, Nzeera
AU - Fahey, John L.
AU - Brooks Jackson, J.
AU - Fox, Lawrence
AU - Chernoff, Miriam
AU - Wu, W. W.Albert
AU - MacPhail, Laurie A.
AU - Vasquez, Guillermo J.
AU - Wohl, David A.
PY - 1997
Y1 - 1997
N2 - 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: We performed a double- blind, randomized, placebo-controlled study of thalidomide as therapy for oral aphthous ulcers in HIV-infected patients. The patients received a four- week course of either 200 mg of thalidomide or placebo orally once per day. They were evaluated weekly for the condition of the ulcers, their quality of life, and evidence of toxicity. Assays were performed for plasma tumor necrosis factor α (TNF-α), soluble TNF-α receptors, and HIV RNA. 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 the 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 log 10 copies per milliliter; increase with placebo, 0.05; P=0.04). With thalidomide treatment there were unexpected increases in the plasma concentrations of TNF-α and soluble TNF-α receptors. Conclusions: Thalidomide is an effective treatment for aphthous ulceration of the mouth and oropharynx in petients with HIV infection.
AB - 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: We performed a double- blind, randomized, placebo-controlled study of thalidomide as therapy for oral aphthous ulcers in HIV-infected patients. The patients received a four- week course of either 200 mg of thalidomide or placebo orally once per day. They were evaluated weekly for the condition of the ulcers, their quality of life, and evidence of toxicity. Assays were performed for plasma tumor necrosis factor α (TNF-α), soluble TNF-α receptors, and HIV RNA. 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 the 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 log 10 copies per milliliter; increase with placebo, 0.05; P=0.04). With thalidomide treatment there were unexpected increases in the plasma concentrations of TNF-α and soluble TNF-α receptors. Conclusions: Thalidomide is an effective treatment for aphthous ulceration of the mouth and oropharynx in petients with HIV infection.
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U2 - 10.1056/NEJM199705223362103
DO - 10.1056/NEJM199705223362103
M3 - Article
C2 - 9154767
AN - SCOPUS:8244247121
SN - 0028-4793
VL - 336
SP - 1487
EP - 1493
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 21
ER -