Liu Shenghua, Lu Shiyao, Xiong Wei, Zhang Feng
Department of Ophthalmology, Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
Central South University Xiangya School of Medicine, Changsha, Hunan, China.
BMJ Open. 2025 Aug 5;15(8):e098243. doi: 10.1136/bmjopen-2024-098243.
Thyroid-associated ophthalmopathy (TAO), the most common orbital disease in adults, is an autoimmune disease of the orbital and periorbital tissues. Typical ocular symptoms of TAO include periorbital oedema, conjunctival congestion and oedema, eyelid retraction, exophthalmos, restrictive strabismus, etc. Hypercholesterolaemia is considered one of the modifiable risk factors of TAO. However, it is unclear whether lipid levels are related to TAO activity and severity and the intravenous glucocorticoids (GC) therapeutic effect. The study aims to evaluate the association between initial lipid and lipoprotein levels, the clinical features of TAO and the efficacy of intravenous methylprednisolone in patients with moderate-to-severe TAO, as well as to explore the oxidative stress-related mechanisms involved.
This real-world prospective cohort study will recruit 178 patients with moderate-to-severe TAO who receive two intravenous methylprednisolone regimens, respectively. The primary outcome is the improvement in the composite index at 3 months after baseline treatment, with secondary outcomes including other ocular features, changes in serological characteristics and major adverse events.
The study protocol was approved by the ethics committees of Xiangya Third Hospital of Central South University (Kuai241012) on 29 November 2024. The study will be conducted according to the guidelines of the Declaration of Helsinki. Participants will be informed of the purpose and content of the study and will complete a written informed consent form before being recruited. The findings will be published in peer-reviewed journals as well as in reports of relevant conferences.
Chinese Clinical Trial Registry (ChiCTR2400094094). Registered on 17 December 2024.
甲状腺相关眼病（TAO）是成人中最常见的眼眶疾病，是一种眼眶和眶周组织的自身免疫性疾病。TAO的典型眼部症状包括眶周水肿、结膜充血和水肿、眼睑退缩、眼球突出、限制性斜视等。高胆固醇血症被认为是TAO的可改变危险因素之一。然而，尚不清楚血脂水平是否与TAO的活动度、严重程度以及静脉糖皮质激素（GC）治疗效果相关。本研究旨在评估中重度TAO患者初始血脂和脂蛋白水平、TAO的临床特征与静脉注射甲泼尼龙疗效之间的关联，并探讨相关的氧化应激机制。
这项真实世界的前瞻性队列研究将招募178例中重度TAO患者，他们将分别接受两种静脉注射甲泼尼龙方案。主要结局是基线治疗后3个月时综合指标的改善情况，次要结局包括其他眼部特征、血清学特征变化和主要不良事件。
本研究方案于2024年11月29日获得中南大学湘雅三医院伦理委员会（快241012）批准。研究将按照《赫尔辛基宣言》的指导原则进行。将向参与者告知研究目的和内容，并在招募前让其签署书面知情同意书。研究结果将发表在同行评审期刊以及相关会议报告中。
中国临床试验注册中心（ChiCTR2400094094）。于2024年12月17日注册。
