甲状腺眼病联合免疫抑制与放疗（CIRTED）试验方案：一项多中心、双盲、析因随机对照试验。
Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: a multi-centre, double-masked, factorial randomised controlled trial.
作者信息
Rajendram Rathie, Lee Richard W J, Potts Mike J, Rose Geoff E, Jain Rajni, Olver Jane M, Bremner Fion, Hurel Steven, Cook Anne, Gattamaneni Rao, Tomlinson Marjorie, Plowman Nicholas, Bunce Catey, Hollinghurst Sandra P, Kingston Laura, Jackson Sue, Dick Andrew D, Rumsey Nichola, Morris Olivia C, Dayan Colin M, Uddin Jimmy M
机构信息
Department of Clinical Science at South Bristol, University of Bristol, UK.
出版信息
Trials. 2008 Jan 31;9:6. doi: 10.1186/1745-6215-9-6.
BACKGROUND
Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed.The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease.
METHODS/DESIGN: Patients with active thyroid eye disease will be randomised to receive (i) azathioprine or oral placebo and (ii) radiotherapy or sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures.
DISCUSSION
The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b) constructing effective inclusion and exclusion criteria to select for active disease; and (c) selecting pragmatic outcome measures.
TRIAL REGISTRATION
Current controlled trials ISRCTN22471573.
背景
由于缺乏关于长期治疗效果的高质量证据，甲状腺眼病的药物治疗仍存在争议。已知糖皮质激素最初有效，但长期使用会有显著副作用，停药后可能复发。目前关于放疗和非甾体类全身免疫抑制疗效的证据相互矛盾，且大多数先前研究为回顾性、非对照、小规模或设计不佳。甲状腺眼病联合免疫抑制与放疗（CIRTED）试验旨在研究放疗和硫唑嘌呤联合标准疗程口服泼尼松龙对活动性甲状腺眼病患者的疗效。
方法/设计：在这项多中心、析因随机对照试验中，活动性甲状腺眼病患者将被随机分组，接受（i）硫唑嘌呤或口服安慰剂，以及（ii）放疗或假放疗。主要结局是12个月时疾病严重程度的改善（使用复合二元指标评估），次要终点包括生活质量评分和卫生经济学指标。
讨论
CIRTED试验是第一项评估放疗和硫唑嘌呤作为甲状腺眼病长期联合免疫抑制治疗方案一部分的作用的研究。它将为放疗和延长免疫抑制在该疾病管理中的作用提供证据，以及它们联合使用的初步数据。在试验设计中，我们特别关注建立（a）对放疗和抗增殖药物全身给药均有效且安全的稳健安慰剂对照和盲法方案；（b）构建有效的纳入和排除标准以选择活动性疾病患者；以及（c）选择实用的结局指标。
试验注册
当前受控试验ISRCTN22471573。
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