Abstract：
Thalidomide is effective for treating severe cutaneous lupus patients. The aim of this study was to observe the optimum effective and maintenance doses of thalidomide to maximize clinical benefit and minimize side effects for patients with cutaneous lupus in China. Sixty-nine patients with lupus rash from eight hospitals in China were enrolled and treated with different doses of thalidomide. We started the dose of thalidomide at 25 mg daily and gradually increased administration dose once a week until erythema was markedly improved. The effective and maintenance doses were documented. The size of skin lesions was noted once a week. Systemic lupus erythematosus disease activity index (SLEDAI) score, levels of erythrocyte sedimentation rate (ESR), and serum TNF-α were measured before and after treatment. The remission rates were evaluated weekly until 8 weeks. Sixty-eight percent of patients showed an effective dose of 50 mg daily; another 13, 10, and 9 % of patients had an effective dose of 100, 75, and 25 mg daily, respectively. The maintenance dose was 50 mg daily for 71 % of the patients, and 100, 75, and 25 mg daily for 9, 14, and 6 % of the patients. SLEDAI score and serum ESR levels significantly decreased 4 weeks after thalidomide treatment. At the end of the fourth week, the rates of complete remission, partial remission, and no response were 56 % (n = 39), 41 % (n = 28), and 3 % (n = 2). At the eighth week, the rate of total remission rose up to 100 %. The most common side effects were drowsiness and constipation. No peripheral neuropathy was observed in these patients. Thalidomide at a dose of 50 mg daily may offer a better benefit to risk ratio in the treatment of Chinese cutaneous lupus patients.
摘要：
沙利度胺可有效治疗严重皮肤狼疮患者。本研究的目的是观察沙利度胺的最佳有效和维持剂量，以最大程度地提高中国皮肤狼疮患者的临床获益和副作用。纳入来自中国八家医院的69例狼疮皮疹患者，并接受不同剂量的沙利度胺治疗。我们开始每日25mg的沙利度胺剂量,并逐渐增加给药剂量,每周一次,直至红斑明显改善。记录有效剂量和维持剂量。每周一次记录皮肤损伤的大小。系统性红斑狼疮疾病活动指数(SLEDAI)评分,红细胞沉降率（ESR）水平，治疗前后测定血清TNF-α水平。每周评估缓解率，直至8周。68%的患者显示有效剂量为每天50毫克；另外13、10和9%的患者有效剂量为每天100、75和25毫克，分别。71%的患者维持剂量为每天50毫克，9、14和6％的患者每天100、75和25mg。沙利度胺治疗4周后SLEDAI评分和血清ESR水平显著下降。在第四周结束时，完全缓解率,部分缓解,56%(n=39)没有反应，41%(n=28)，和3%(n=2)。在第八周，总缓解率上升至100%。最常见的副作用是困倦和便秘。在这些患者中未观察到周围神经病变。沙利度胺每天50mg的剂量可能在中国皮肤狼疮患者的治疗中提供更好的获益风险比。
