thyroid-associated opthalmopathy
Conditions
Interventions
Group 1:4-week protocol
Group 2:12-week protocol
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women older than 18 years of age; 2. The more severe side of the eye was diagnosed as active moderate-to-severe TAO; 3. Thyroid function was normal within 1 month before enrollment,including those taking antihyperthyroidism or who do not need to take it; 4. Weight between 40-70 kg; 5. Have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe heart, liver, and renal insufficiency, such as myocardial ischemia or myocardial infarction, arrhythmia and cardiac insufficiency; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >= upper limit of normal value x 1.5 times; creatinine >= upper limit of normal; estimated glomerular filtration rate <60 ml·min-1·(1.73 m2)-1; 2. Gastric ulcer, gastric bleeding, diabetes, other autoimmune diseases, uncontrolled hypertension, tuberculosis, mental illness, active hepatitis and glaucoma; 3. Allergic to glucocorticoids; 4. With a positive pregnancy test or breast-feeding; 5. Received radioactive iodine treatment or received hepatitis vaccine within 3 months before enrollment; 6. Had systemic immunotherapy for Graves' ophthalmology within 1 month before enrollment, including oral or IVGC, or other immunosuppressants; and had orbital radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| extraocular muscles MRI;fasting plasma glucose;glycated hemoglobin;blood total cholesterol;blood triglycerides;high-density lipoprotein;low-density lipoprotein;blood osteocalcin;type I procollagen amino terminal extension peptide;blood alanine aminotransferase;blood aspartate aminotransferase;blood creatinine;blood urea nitrogen;blood uric acid;blood alkaline phosphatase;body mass index;blood lymphocyte subpopulation;blood thyroxine;blood triiodothyronine;blood thyroid stimulating hormone; | — |
Countries
China
Contacts
Public ContactLu Yingli
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed