Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection

New England Journal of Medicine

Volumn 336, Issue 21, 1997, Pages 1487-1493

  Jacobson, Jeffrey M ^a,i   Greenspan, John S ^b   Spritzler, John ^c   Ketter, Nzeera ^d   Fahey, John L ^e   Brooks Jackson, J ^f   Fox, Lawrence ^d   Chernoff, Miriam ^c   Wu, W W Albert ^f   MacPhail, Laurie A ^b   Vasquez, Guillermo J ^g   Wohl, David A ^h  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF PUERTO RICO SCHOOL OF MEDICINE   (Puerto Rico)

^h UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

ⁱ VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; THALIDOMIDE;

ADOLESCENT; ADULT; APHTHOUS STOMATITIS; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; SOMNOLENCE; ULCER HEALING;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; DOUBLE-BLIND METHOD; FEMALE; HIV-1; HUMANS; MALE; QUALITY OF LIFE; RECEPTORS, TUMOR NECROSIS FACTOR; STOMATITIS, APHTHOUS; THALIDOMIDE; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 8244247121     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199705223362103     Document Type: Article

References (43)

1. MacPhail LA, Greenspan D, Feigal DW, Lennette ET, Greenspan JS. Recurrent aphthous ulcers in association with HIV infection: description of ulcer types and analysis of T-lymphocyte subsets. Oral Surg Oral Med Oral Pathol 1991;71:678-83.
2. Bach MC, Valenti AJ, Howell DA, Smith TJ. Odynophagia from aphthous ulcers of the pharynx and esophagus in the acquired immunodeficiency syndrome (AIDS). Ann Intern Med 1988;109:388-9.
3. Youle M, Clarbour J, Farthing C, et al. Treatment of resistant aphthous ulceration with thaltdomide in patients positive for HIV antibody. BMJ 1989;298:432.
4. Gorin I, Vilette B, Gehanno P, Escande JP. Thalidomide in hyperalgic pharyngeal ulceration of AIDS. Lancet 1990;335;1343.
5. Georghiou PR, Kemp RJ. HIV-associated esophageal ulcers treated with thalidomide. Med I Aust 1990;152;382-3.
6. Ryan J, Colman J, Pedersen J. Thalidomide to treat esophageal ulcer in AIDS. N Engl J Med 1992;327:208-9.
7. Radeff B, Kuffer R, Samson J. Recurrent aphthous ulcer in patient infected with human immunodeficiency virus: successful treatment with thalidomide. J Am Acad Dermatol 1990;23:523-5.
8. Mascaro IM, Lecha M, Torras H. Thalidomide in the treatment of recurrent, necrotic, and giant mucocutaneous aphthae and aphthosis. Arch Dermatol 1979;115:636-7
9. Torras H, Lecha M, Mascaro IM. Thalidomide treatment of recurrent necrotic giant mucocutaneous aphthae and aphthosis. Arch Dermatol 1982;118:875.
10. Bowers PW, Powell RJ. Effect of thalidomide on orogenital ulceration. BMJ 1983;287:799-800.
11. Jenkins JS, Powell RJ, Allen BR, Littlewood SM, Maurice PDL, Smith NJ. Thalidomide in severe orogenital ulceration. Lancet 1984;2:1424-6.
12. Grinspan D. Significant response of oral aphthosis to thalidomide treatment. J Am Acad Dermatol 1985;12:85-90.
13. Kurkcuoglu N, Atakan N, Eksioglu M. Thalidomide in the treatment of recurrent necrotic mucocutaneous aphthae. Br J Dermatol 1985;112: 632.
14. Paterson DL, Georghiou PR, Allworth AM, Kemp RJ. Thalidomide as treatment of refractory aphthous ulceration related to human immunodeficiency virus infection. Clin Infect Dis 1995;20:250-4.
15. Revuz J, Guillaume JC, lanier M, et al. Crossover study of thalidomide vs placebo in severe recurrent aphthous stomatitis. Arch Dermatol 1990; 126:923-7.
16. Sampaio EP, Sarno EN, Galilly R, Cohn ZA, Kaplan G. Thalidomide selectively inhibits tumor necrosis factor α production by stimulated human monocytes. J Exp Med 1991;173:699-703.
17. Peterson PK, Hu S, Sheng WS, et al. Thalidomide inhibits tumor necrosis factor-α production by lipopolysaccharide- and lipoarabinomannan-stimulated human microglial cells. J Infect Dis 1995;172:1137-40.
18. Makonkawkeyoon S, Limson-Pobre RNR, Moreira AL, Schauf V, Kaplan G. Thalidomide inhibits the replication of human immunodeficiency virus type 1. Proc Natl Acad Sci U S A 1993;90;5974-8.
19. Sampaio EP, Moreira AL, Sarno EN, Malta AM, Kaplan G. Prolonged treatment with recombinant interferon α induces erythema nodosum leprosum in lepromatous leprosy patients. J Exp Med 1992;175:1729-37
20. Tramontana JM, Utaipat U, Molloy A, et al. Thalidomide treatment reduces tumor necrosis factor α production and enhances weight gain in patients with pulmonary tuberculosis. Mol Med 1995;1:384-97
21. Poli G, Kinter A, Justement JS, et al. Tumor necrosis factors α functions in an autocrine manner in the induction of human immunodeficiency virus expression. Proc Natl Acad Sci U S A 1990;87:782-5.
22. Wu AW, Rubin HR, Mathews WC, et al. A health status questionnaire using 30 items from the Medical Outcomes Study: preliminary validation in persons with early HIV infection. Med Care 1991;29:786-98.
23. Bergner M, Bobbitt RA, Carter WB, Gilson BS. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981;19:787-805.
24. Mulder J, McKinney N, Christopherson C, Sninsky J, Greenfield L, Kwok S. Rapid and simple PCR assay for quantitation of human immunodeficiency virus type 1 RNA in plasma: application to acute retroviral infection. J Clin Microbiol 1994;32:292-300.
25. Lehmann EL. Nonparametries: statistical methods based on ranks. San Francisco: Holden-Day, 1975:55-65, 123-32, 300.
26. Breslow N, Day NE. Statistical methods in cancer research. Vol. 1. The analysis of case-control studies. Lyon, France: International Agency for Research on Cancer, 1980:128. (IARC scientific publications no. 32.)
27. Kaptan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
28. Kim K, DeMets DL. Design and analysis of group sequential tests based on the type I error spending rate function. Biometrika 1987;74:149-54.
29. Wulff CH, Hoyer H, Asboe-Hansen G, Brodthagen H. Development of polyneuropathy during thalidomide therapy. Br J Dermatol 1985;112: 475-80.
30. Lenz W. Thalidomide and congenital abnormalities. Lancet 1962;1: 45.
31. Nowack E. Die sensible Phase bei der Thalidomid-Embryopathie. Humangenetik 1965;1:516-36.
32. Kreipe U. Mißbildungen innerer Organe bei Thalidomidembryopathie. Arch Kinderheilkd 1967;176:33-61.
33. D'Amato RJ, Loughnan MS, Flynn E, Folkman J. Thalidomide is an inhibitor of angiogenesis. Proc Natl Acad Sci U S A 1994;91:4082-5.
34. Vogelsang GB, Farmer ER, Hess AD, et al. Thalidomide for the treatment of chronic graft-versus-host disease. N Engl J Med 1992;326:1055-8.
35. Sheskin J, Convit J. Results of a double blind study of the influence of thalidomide on the lepra reaction. Int J Lepr Other Mycobact Dis 1969; 37:135-46.
36. Woo S-B, Sonis ST. Recurrent aphthous ulcers: a review of diagnosis and treatment. J Am Dent Assoc 1996;127:1202-13.
37. Kotler DP, Reka S, Orenstein JM, Fox CH. Chronic idiopathic esophageal ulceration in the acquired immunodeficiency syndrome: characterization and treatment with corticosteroids. J Clin Gastroenterol 1992;15: 284-90.
38. Sampaio EP, Kaplan G, Miranda A, et al. The influence of thalidomide on the clinical and immunologic manifestation of erythema nodosum leprosum. J Infect Dis 1993;168;408-14.
39. Klausner JD, Makonkawkeyoon S, Akarasewi P, et al. The effect of thalidomide on the pathogenesis of human immunodeficiency virus type 1 and M. tuberculosis infection. J Acquir Immune Defic Syndr Hum Retrovirol 1996;11:247-57
40. Mellors JW, Rinaldo CR Jr, Gupta P, White RM, Todd JA, Kingsley LA. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 1996;272;1167-70.
41. Godfried MH, van der Poll T, Jansen J, et al. Soluble receptors for tumour necrosis factor: a putative marker of disease progression in HIV infection. AIDS 1993;7:33-6.
42. Aukrust P, Liabakk N-B, Muller F, Lien E, Espevik T, Froland SS. Serum levels of tumor necrosis factor-α (TNFα) and soluble TNF receptors in human immunodeficiency virus type 1 infection - correlations to clinical, immunologic, and virologic parameters. J Infect Dis 1994;169:420-4. [Erratum, J Infect Dis 1994;169:1186-7]
43. Godfried MH, van der Poll T, Weverling GJ, et al. Soluble receptors for tumor necrosis factor as predictors of progression to AIDS in asymptomatic human immunodeficiency virus type 1 infection. J Infect Dis 1994; 169:739-45.