Kyriakis K P, Kontochristopoulos G J, Panteleos D N
Department of Dermatology, The West Attica General Hospital and Leprosy Center, Athens, Greece.
Int J Dermatol. 2000 Mar;39(3):218-22. doi: 10.1046/j.1365-4362.2000.00953.x.
Low-dose thalidomide therapy (median dose 100 mg/day, 50-200 mg/day) in chronic discoid lupus erythematosus was studied with regard to efficacy, tolerance, and toxicity in 22 patients. Intense contraceptive precautions were taken in women patients of childbearing age.
An open uncontrolled trial was conducted. Age, the total drug intake, disease duration, extent/severity, and adverse reactions were studied with regard to the final clinical outcome. The follow-up duration was 1.8 years (range 1 month to 3 years).
With the exception of age (inverse correlation, P < 0.01), the parameters studied did not influence the final clinical amelioration: complete responders numbered 54.5%, partial responders 22.7%, and 13.6% were withdrawn from the trial with complaints of intolerance. The initial (first month) clinical response correlated significantly with the final one (P < 0.01). Drowsiness (40.9%) and somnolence (18.2%) were the most common side-effects, without affecting seriously the daily life of the participants. No case of real neurotoxicity was confirmed. Relapses occurred within 39.4 +/- 21.4 days after drug withdrawal, presenting a milder clinical picture.
In the context of a predictable final outcome, low-dose thalidomide therapy is effective as an alternative choice in cases resistant to the usual treatment.
对22例慢性盘状红斑狼疮患者进行了低剂量沙利度胺治疗（中位剂量100毫克/天，50 - 200毫克/天），研究其疗效、耐受性和毒性。对育龄期女性患者采取了严格的避孕措施。
进行了一项开放的非对照试验。研究了年龄、药物总摄入量、病程、范围/严重程度和不良反应与最终临床结果的关系。随访时间为1.8年（范围1个月至3年）。
除年龄外（呈负相关，P < 0.01），所研究的参数均未影响最终的临床改善情况：完全缓解者占54.5%，部分缓解者占22.7%，13.6%因不耐受主诉退出试验。初始（第1个月）临床反应与最终反应显著相关（P < 0.01）。嗜睡（40.9%）和昏睡（18.2%）是最常见的副作用，但未严重影响参与者的日常生活。未证实有真正的神经毒性病例。停药后39.4 +/- 21.4天内出现复发，临床表现较轻。
在可预测最终结果的情况下，低剂量沙利度胺治疗作为常规治疗耐药病例的替代选择是有效的。
