Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change of Clinical Activity Score (CAS) score
研究概览
简要总结
The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General conditions:
- •clinically diagnosed as thyroid disease;
- •able and willing to participate in clinical trials and ensure regular follow-up.
- •Eye condition:
- •patients with monocular disease diagnosed by TAO;
- •EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
- •the course of eye disease was less than 12mo and had not been treated in the past.
排除标准
- •General situation:
- •patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
- •blood pressure still fluctuated > 180/110mmHg after medication;
- •obvious liver and kidney insufficiency;
- •contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
- •patients with severe abnormal blood coagulation;
- •patients with other systemic immune diseases;
- •any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
- •history of chronic infection;
- •pregnant and lactating women.
- •Eye conditions:
- •B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
- •moderate to severe TAO, in either eye requiring local or systemic treatment;
- •periorbital infectious diseases, hemorrhagic diseases;
- •uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.
- •those who studied the eyes who had a history of arbitrary surgery;
- •those who were considered by the researchers to be excluded.
研究组 & 干预措施
Periorbitally Injected Glucocorticoids
Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Change of Clinical Activity Score (CAS) score
时间窗: baseline、3months、6months、9months、12months
Comparison of CAS scores before and after treatment in each arm and an inter-arm. The range of CAS scores is 0-7, with 3 as the boundary. The higher the score, the higher the activity.
Change of NOSPECS score
时间窗: baseline、3months、6months、9months、12months
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm. The NOSPECS score was 0-6. The higher the score, the higher the severity.
次要结局
- Quality of life questionnaires (GO-QoL)(baseline、3months、6months、9months、12months)
- adverse events(baseline、3months、6months、9months、12months)
研究者
Huasheng Yang
Principal Investigator, Clinical Professor
Sun Yat-sen University