thyroid associated ophthalmopathy
Conditions
Interventions
Experimental group:Radiotherapy combined with rituximab
Sponsors
the Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The patient is 18 years old and above. 2. Comply with the internationally recognized TAO diagnosis. 3. It belongs to the TAO active period (based on the 2016ETA-EUGOGO Guidelines: Management Judgment of Graves Eye Disease). 4. Hormone (methylprednisolone) treatment accumulates 4.5g, and hormone treatment is not sensitive (sensitivity criterion: 2 or more effective indicators are met, and 0 aggravation indicators are met): (1) Effective indicators: 1) The degree of exophthalmos is reduced by at least 2mm; 2) The CAS score should be reduced by at least 2 points; 3) Improvement of diplopia (decline in diplopia score); 4) Improvement of eye movement (decline in eye movement score); (2) Aggravating indicators: 1) The degree of exophthalmos increased by at least 2mm; 2) CAS increased by at least 2 points; 3) Increased diplopia (increased diplopia score); 4) Deterioration of eye movement (increased eye movement score); 5) DON (decreased visual acuity, and orbital imaging examination shows that the extraocular muscles are oppressing the orbital apical optic nerve). 5. Thyroid function was normal before enrollment (FT3, FT4 were normal, and TSH was normal or decreased). 6. Sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Severe cardiac, liver, and renal insufficiency (myocardial ischemia or myocardial infarction, arrhythmia and cardiac insufficiency; ALT, AST >= upper limit of normal x 1.5 times; creatinine >= upper limit of normal); 2. Patients with infectious diseases such as viral hepatitis, AIDS, and syphilis; 3. Patients with diabetes, uncontrolled hypertension, or mental illness; Received radiotherapy/immunosuppressive/surgical treatment within 4.3 months; 5. Patients with a history of allergy to rituximab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in eyeball proptosis;changes in clinical activity score;changes in diplopia score;changes in eye movement score;corrected visual acuity changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in thyroid autoantibody levels;quality of life assessment score;orbital enhanced magnetic resonance changes;changes in serum cytokine levels;changes in lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactZhou Huifang
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed