Graves' ophthalmopathy
Conditions
Interventions
high-dose group:High-dose group: Methylprednisolone 0.5g, administered intravenously once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks, followed by a follow-up period.
low-dose group:Methylprednisolone is administered at a dose of 1mg/kg, given as an intravenous injection once daily for 3 consecutive days, repeated every 4 weeks for a total of 24 weeks
followed by a follow-up period.
Sponsors
Naval Medical University's Second Affiliated Hospital (Shanghai Changzheng Hospital)
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily accept the study and sign the informed consent form. 2. The age range is 25 to 70; both males and females are eligible. 3. Newly diagnosed with Graves' ophthalmopathy, active moderate to severe patients (Criteria for moderate to severe eye disease: 1)Lid retraction >=2mm; 2) Moderate to severe involvement of orbital soft tissues; 3) Proptosis =20mm; 4) Periodic or persistent diplopia. Meeting any one of the above 4 criteria is sufficient. Criteria for active Graves' ophthalmopathy (GO): CAS score >=4 points; Scoring criteria: 1) Spontaneous retro-orbital pain; 2) Pain on eye movement; 3) Conjunctival congestion; 4) Lid congestion; 5) Chemosis; 6) Edema of the caruncle; 7) Lid edema. Each of the above 7 symptoms is scored as 1 point if present and 0 points if absent). 4. The onset of Graves' ophthalmopathy should not exceed 12 months, and the patient should not have been treated with corticosteroids or other immunosuppressive agents. 5. Women of childbearing age must take effective contraceptive measures. 6. The study subjects should have essentially controlled hyperthyroidism during screening. Thyroid function is normal, or only mildly abnormal, defined as FT4 and FT3 levels within 50% of the normal upper and lower limits.
Exclusion criteria
Exclusion criteria: 1. Pregnant women, women who are breastfeeding, or women planning to become pregnant during the trial period. 2. Severe heart diseases such as myocardial infarction, unstable angina, chronic heart failure, etc. 3. Have a clear liver disease, or ALT is higher than 1.5 times the upper limit of normal. 4. Have chronic kidney disease or serum creatinine >135 umol/L (>1.5 mg/dL). 5. Diabetes, and HbA1c > 9.0%. 6. Have a history of alcohol abuse or drug use. 7. The subject's white blood cell count is <4.0×10^9/L or platelet count is <80×10^9/L. 8. Have obvious anemia (hemoglobin in males: <110g/L, in females: <100g/L). 9. Patients with mental illness, those who cannot cooperate. 10. Those with optic nerve involvement requiring orbital decompression surgery, defined as a decrease in vision of =2 lines in the past 6 months, new visual field defects, or color vision defects. 11. Corneal ulcers, contraindications to corticosteroid treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| exophthalmos or Proptosis;CAS score; | — |
Countries
China
Contacts
Public ContactJunjie Zou
Naval Medical University's Second Affiliated Hospital (Shanghai Changzheng Hospital)
Outcome results
None listed