thyroid associated ophthalmopathy
Conditions
Interventions
Patients with moderately to severely active TAO:N/A
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years and over; 2. Meet the TAO diagnostic criteria: A. History of abnormal thyroid function (FT3, FT4, TT3, TT4, TSH, TRAb, TPOAb, or TGAb, any one abnormality); B. With eyelid withdrawal, eye protrusion (eye protrusion exceeds the normal upper limit, that is, 14mm, not less than 3mm), and at least one typical eye symptom of eye movement disorder; C. Imaging evidence of extraocular muscle involvement (one or more extraocular muscle thickening); 3. Meet the TAO standard for activity period (at least one of the following performance is assessed as activity period): A.CAS score of 3 points; (CAS score of 7 items, each count of 1 point: eyelid congestion, moderate / severe eyelid edema, moderate / severe conjunctival congestion, conjunctival edema, spontaneous retrobulbar pain, gaze eye pain, eye pain during activity, tear pad swelling); B. Orbital MRI shows ocular muscle hyperintense signal; 4. Meet moderate to severe TAO standards (with at least two following performances): A. Bear withdrawal 2mm; B. Moderate to severe soft tissue damage; C. exophthalmos; D. Stable or intermittent diplopia; Supplement: If both eyes meet the inclusion criteria, higher CAS scores are considered; consistent CAS scores and multiple moderate and severe evaluation criteria are considered as the study subjects; and the same criteria are designated by the researcher. 5. Hormonal shock therapy is proposed.
Exclusion criteria
Exclusion criteria: 1. Severe heart, liver and renal insufficiency; patients with diabetes, uncontrolled hypertension and psychiatric diseases; SLE and RA; patients with tuberculosis, HIV infection or AIDS; glucocorticoid allergy; pregnant women or lactation; patients with hepatitis and other vaccines within 1 month before enrollment; 2. Previous hormone shock therapy; previous systemic immunotherapy, including oral or intravenous 1g of glucocorticoids or more, various immunosuppressive agents, and TAO-related targeted drugs; 3. Obtain orbital radiotherapy and eye surgery within 1 months; 4. Abnormal thyroid function, optic neuropathy and / or keratopathy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| effective percentage; | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate;Safety indicators; | — |
Countries
China
Contacts
Public ContactHuifang Zhou
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed