作者： European Group on Graves' Orbitopathy,Bartalena L,Wiersinga W,et al.

　　出处：The New England journal of medicine.2011-05-19;364(20):1920-31.

　　文献类型：临床试验 PUBMED链接：PMID 21591944

　　Abstract：BACKGROUND:Oxygen free radicals and cytokines play a pathogenic role in Graves' orbitopath... BACKGROUND:Oxygen free radicals and cytokines play a pathogenic role in Graves' orbitopathy.

　　METHODS:We carried out a randomized, double-blind, placebo-controlled trial to determine the effect of selenium (an antioxidant agent) or pentoxifylline (an antiinflammatory agent) in 159 patients with mild Graves' orbitopathy. The patients were given selenium (100 μg twice daily), pentoxifylline (600 mg twice daily), or placebo (twice daily) orally for 6 months and were then followed for 6 months after treatment was withdrawn. Primary outcomes at 6 months were evaluated by means of an overall ophthalmic assessment, conducted by an ophthalmologist who was unaware of the treatment assignments, and a Graves' orbitopathy-specific quality-of-life questionnaire, completed by the patient. Secondary outcomes were evaluated with the use of a Clinical Activity Score and a diplopia score.

　　RESULTS:At the 6-month evaluation, treatment with selenium, but not with pentoxifylline, was associated with an improved quality of life (P<0.001) and less eye involvement (P=0.01) and slowed the progression of Graves' orbitopathy (P=0.01), as compared with placebo. The Clinical Activity Score decreased in all groups, but the change was significantly greater in the selenium-treated patients. Exploratory evaluations at 12 months confirmed the results seen at 6 months. Two patients assigned to placebo and one assigned to pentoxifylline required immunosuppressive therapy for deterioration in their condition. No adverse events were evident with selenium, whereas pentoxifylline was associated with frequent gastrointestinal problems.

　　CONCLUSIONS:Selenium administration significantly improved quality of life, reduced ocular involvement, and slowed progression of the disease in patients with mild Graves' orbitopathy. (Funded by the University of Pisa and the Italian Ministry for Education, University and Research; EUGOGO Netherlands Trial Register number, NTR524.).

　　中文摘要：

　　背景：氧自由基及细胞因子在Graves'眼病发病中有致病的作用。方法：进行随机双盲空白对照试验，评价159名有轻度Graves'眼病患者在服用硒(抗氧化物)和己酮可可碱(抗炎物)后的疗效。所有患者随机分配服用硒(100ug，Bid)及己酮可可碱(600mg，Bid)或安慰剂(Bid)达六个月，然后根据治疗六个月撤药。六个月后通过眼科专家(不知道患者是否用药)评估来评价主要结果，并对患者进行Graves'眼病生活质量问卷。次要结果由临床活动评分及复视评分来评价。结论：在第六周时，服用硒但没有服用己酮可可碱组与安慰剂组比较，前者生活质量提高(p<0.001)、眼部肌受累减少(p=0.01)及Graves'眼病进展延缓。临床活动评分在所有组都是减少的，但是在硒治疗后的患者得到明显改善。在12个月的探索评价证实在6个月时看到的结果。两个患者服用安慰剂及一个患者服用己酮可可碱要求免疫治疗患者恶化状况。用硒治疗者没有副反应，而用己酮可可碱有胃肠道反应。总结:口服硒可改善患者的生活质量，减少眼肌受累，延缓Graves'眼病的进展。

　　主题词：

　　Adult; Anti-Inflammatory Agents; Antioxidants; Disease Progression; Double-Blind Method; Female; Graves Ophthalmopathy; Humans; Male; Pentoxifylline; Quality of Life; Selenium;