Revuz J, Guillaume J C, Janier M, Hans P, Marchand C, Souteyrand P, Bonnetblanc J M, Claudy A, Dallac S, Klene C
Services de Dermatologie, Centre Hôpitalier Universitaire Henri Mondor, Créteil, France.
Arch Dermatol. 1990 Jul;126(7):923-7.
A multicentric crossover randomized trial of 100 mg of thalidomide vs placebo each for 2 months was conducted in patients with severe aphthous stomatitis of more than 6 months' duration. Seventy-three patients were included. Complete remission was obtained in 32 patients who received thalidomide and in 6 patients who received placebo. The confidence interval of the difference between the two treatments ranged from 25% to 53%. Most of the patients who did not achieve a complete remission had a dramatic improvement with regard to the number of aphthae when they were receiving thalidomide. Thirteen of 17 patients who had a complete remission while they were receiving thalidomide had a recurrence with placebo, 19 +/- 9 (mean +/- SD) days after stopping this drug. Side effects were significantly more frequent with thalidomide, especially drowsiness and constipation. We concluded that thalidomide in a dosage of 100 mg/d is an effective treatment of severe aphthous stomatitis but is not without some risk.
对病程超过6个月的重度复发性口腔溃疡患者进行了一项多中心交叉随机试验，100毫克沙利度胺与安慰剂各服用2个月。共纳入73例患者。接受沙利度胺治疗的32例患者和接受安慰剂治疗的6例患者实现了完全缓解。两种治疗方法之间差异的置信区间为25%至53%。大多数未实现完全缓解的患者在接受沙利度胺治疗时，口腔溃疡数量有显著改善。在接受沙利度胺治疗期间实现完全缓解的17例患者中，有13例在停用该药后19±9（均值±标准差）天因服用安慰剂而复发。沙利度胺的副作用明显更常见，尤其是嗜睡和便秘。我们得出结论，100毫克/天剂量的沙利度胺是治疗重度复发性口腔溃疡的有效方法，但并非没有风险。
