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首页> 外文期刊>The New England journal of medicine >Selenium and the course of mild Graves' orbitopathy.
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Selenium and the course of mild Graves' orbitopathy.

机译：硒和轻度Graves眼眶病的病程。

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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 mug 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mg twice daily), or placebo (twice daily) orally for 6 months and were then followed for 6 months after treatment was withdrawn.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.).
机译：背景：氧自由基和细胞因子在Graves眼眶病中起着致病作用。方法：我们进行了一项随机，双盲，安慰剂对照试验，以确定159例轻度Graves眼眶病患者中硒（抗氧化剂）或己酮可可碱（抗炎剂）的作用。给予患者口服硒（每天两次，每次100杯），己酮可可碱（每天两次，每次600毫克）或安慰剂（每天两次），持续6个月，然后在撤药后随访6个月。通过不了解治疗方案的眼科医生进行的全面眼科评估和患者完成的Graves眼眶病特定生活质量问卷，对6个月时的主要结局进行了评估。使用临床活动评分和复视评分对次要结局进行评估。结果：在为期6个月的评估中，使用硒而不是己酮可可碱治疗可改善生活质量（P <0.001）和减少眼睛受累（P = 0.01），并减慢Graves眼眶病的进展（P = 0.01），与安慰剂相比。所有组的临床活动评分均下降，但硒治疗患者的变化明显更大。 12个月时的探索性评估证实了6个月时的结果。分配给安慰剂的两名患者和分配给己酮可可碱的一名患者需要免疫抑制疗法以改善病情。硒无明显不良反应，而己酮可可碱与胃肠道疾病相关。结论：轻度Graves眼眶病患者服用硒显着改善了生活质量，减少了眼部受累，并减慢了疾病的进展。 （由比萨大学和意大利教育，大学与研究部出资; EUGOGO荷兰试验注册号为NTR524。）。

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