Randomised comparison of thalidomide versus placebo in toxic epidermal necrolysis

Lancet

Volumn 352, Issue 9140, 1998, Pages 1586-1589

  Wolkenstein, Pierre ^a   Latarjet, Jacques ^b   Roujeau, Jean Claude ^a   Duguet, Corinne ^c   Boudeau, Sylvie ^c   Vaillant, Loïc ^d   Maignan, Michel ^e   Schuhmacher, Marie Hélène ^e   Milpied, Brigitte ^f   Pilorget, Alain ^f   Bocquet, Hélène ^a   Brun Buisson, Christian ^a   Revuz, Jean ^a  

^a HENRI MONDOR HOSPITAL   (France)

^b Hôpital Saint Luc Saint Joseph   (France)

^c Laphal Laboratories   (France)

^d SERVICE DE DERMATOLOGIE   (France)

^e CHU NANCY BRABOIS   (France)

^f HÔTEL DIEU   (France)

Author keywords

[No Author keywords available]

Indexed keywords

INTERLEUKIN 6; THALIDOMIDE; TUMOR NECROSIS FACTOR ALPHA;

ADULT; AGED; ARTICLE; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; FEMALE; HUMAN; INTRAGASTRIC DRUG ADMINISTRATION; MALE; MORTALITY; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TOXIC EPIDERMAL NECROLYSIS; TREATMENT FAILURE;

EID: 0032517486     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(98)02197-7     Document Type: Article

References (28)

1. 1 Roujeau J-C, Stern RS. Severe cutaneous adverse reactions to drugs. N Engl J Med 1994; 331: 1272-85.
2. 2 Bastuji-Garin S, Rzany B, Stern RS, Shear NH, Naldi L, Roujeau J-C. A clinical classification of cases of toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme. Arch Dermatol 1993; 129: 92-96.
3. 3 Roujeau J-C, Kelly JP, Naldi L, et al. Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis. N Engl J Med 1995; 333: 1600-07.
4. 4 Sherertz EF, Jegasothy BV, Lazarus GS. Phenytoin hypersensitivity reaction presenting with toxic epidermal necrolysis and severe hepatitis. Report of a patient treated with corticosteroid "pulse therapy". J Am Acad Dermatol 1985; 12: 178-81.
5. 5 Halebian PH, Corder VJ, Madden MR, Finklestein JL, Shires GT. Improved burn center survival of patients with toxic epidermal necrolysis managed without corticosteroids. Ann Surg 1986; 204: 503-12.
6. 6 Kim PS, Goldfarb IW, Gaisford JC, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a pathophysiologic review with recommendations for a treatment protocol. J Burn Care Rehabil 1983; 4: 91-100.
7. 7 Kelemen JJ, Cioffi WG, McManus WF, Mason AD, Pruitt BA. Burn center care for patients with toxic epidermal necrolysis. J Am Coll Surg 1995; 180: 273-78.
8. 8 Kamanabroo D, Schmitz-Landgraf W, Czarnetski BM. Plasmapheresis in severe drug-induced toxic epidermal necrolysis. Arch Dermatol 1985; 121: 1548-49.
9. 9 Hewitt J, Ormerod AD. Toxic epidermal necrolysis treated with cyclosporin. Clin Exp Dermatol 1992; 17: 264-65.
10. 10 Heng MC, Allen SG. Efficacy of cyclophosphamide in toxic epidermal necrolysis: clinical and pathophysiologic aspects. J Am Acad Dermatol 1991; 25: 778-86.
11. 11 Redondo P, Defelipe I, Delapena A, Aramendia JM, Vanaclocha V. Drug-induced hypersensitivity syndrome and toxic epidermal necrolysis - treatment with N-acetylcysteine. Br J Dermatol 1997; 136: 645-46.
12. 12 Revuz J, Penso D, Roujeau J-C, et al. Toxic epidermal necrolysis: clinical findings and prognosis factors in 87 patients. Arch Dermatol 1987; 123: 1160-65.
13. 13 Paul C, Wolkenstein P, Adle H, Wechsler J, Revuz J, Roujeau J-C. Apoptosis as a mechanism of keratinocyte death in toxic epidermal necrolysis and Stevens-Johnson syndrome. Br J Dermatol 1996; 134: 710-14.
14. 14 Klausner JD, Freedman VH, Kaplan G. Thalidomide as an anti-TNF-α inhibitor: implications for clinical use. Clin Immunol Immunopathol 1996; 81: 219-23.
15. 15 Moreira AL, Sampaio EP, Zmuidzinas A, Frindt P, Smith KA, Kaplan G. Thalidomide exerts its inhibitory action on tumor necrosis factor α by enhancing mRNA degradation. J Exp Med 1993; 177: 1675-80.
16. 16 Vogelsang GB, Farmer ER, Hess AD, et al. Thalidomide for the treatment of chronic graft-versus-host disease. N Engl J Med 1992; 326: 1055-58.
17. 17 Klausner JD, Makonkawkeyoon S, Akarasewi S, et al. The effect of thalidomide on the pathogenesis of HIV-1 and M tuberculosis infection. J AIDS Hum Retroviruses 1996; 11: 247-57.
18. 18 Lund CC, Browder NC. The estimation of areas burns. Surg Gynecol Obstet 1994; 79: 352-59.
19. 19 Le Gall JR, Loirat P, Alperovitch A, et al. A simplified acute physiology score for ICU patients. Crit Care Med 1984; 12: 975-77.
20. 20 Correia O, Chosidow O, Saiag Ph, et al. Evolving pattern of drug-induced toxic epidermal necrolysis. Dermatology 1993; 186: 32-37.
21. 21 Mehta CV, Patel NR. Exact logistic regression: theory and examples. Stat Med 1995; 14: 2143-60.
22. 22 Jacobson JM, Greenspan JS, Spritzler J, et al. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. N Engl J Med 1997; 336: 1487-93.
23. 23 Chao NJ, Parkers PM, Niland JC, et al. Paradoxical effect of thalidomide prophylaxis on chronic graft-vs-host disease. Biol Blood Marrow Transplant 1996; 2: 86-92.
24. 24 Günsler V. Thalidomide in human immunodeficiency virus (HIV) patients. Drug Saf 1992; 7: 116-34.
25. 25 Fisher CJ, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. N Engl J Med 1996; 334: 1698-702.
26. 26 Shannon EJ, Sandoval F. Thalidomide can be either agonistic or antagonistic to LPS evoked synthesis of TNF-α by mononuclear cells. Immunopharmacol Immunotoxicol 1996; 18: 59-72.
27. 27 Nishimura K, Hashimoto Y, Iwasaki S. Enhancement of phorbol ester-induced production of tumor necrosis factor α by thalidomide. Biochem Biophys Res Commun 1994; 199: 455-60.
28. 28 Zwingenberger K, Wnendt S. Immunomodulation by thalidomide: systematic review of the literature and of unpublished observations. J Inflamm 1996; 46: 177-211.