inflammatory pseudotumor
Conditions
Interventions
Experimental group:High dose of glucocorticoid intravenous infusion shock therapy (1g * 3D, 500mg * 3D, 240mg * 3D), oral sequential reduction + Tacrolimus 2mg orally
Control group:High dose of glucocorticoid intravenous infusion shock therapy (1g * 3D, 500mg * 3D, 240mg * 3D) + oral sequential reduction
Sponsors
the First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consistent with the diagnosis of orbital inflammatory pseudotumor; 2. Aged 12-65 years; 3. Best corrected visual acuity: 0.1 ~ 1.0; 4. Intraocular pressure 10 ~ 21mmHg; 5. The total amount of white blood cells in peripheral blood was within the normal range; 6. Normal bone marrow reserve function and normal liver and kidney function; 7. No obvious genetic diseases; 8. Women of child-bearing age (15-49 years) must undergo a pregnancy test within 7 days before the start of treatment and the result is negative; 9. Willing to submit to the trial protocol and sign the informed consent to participate in the study after the review and approval of the ethics committee; 10. Duration of > for 12 months.
Exclusion criteria
Exclusion criteria: 1. Orbital specific inflammation: inflammation caused by bacteria, fungi and parasites in the orbit, orbital cellulitis; 2. Orbital non-specific inflammation: painful ophthalmoplegia, sarcoidosis, middle linear necrotizing granuloma, Kimura's disease, tuberous arteritis, temporal arteritis, lymphoma, benign lymphoepithelial lesion, fleshomatosis, metastatic cancer, Wegener granuloma; 3. Orbital tumor; Dermoid cyst, cavernous hemangioma, orbital meningioma, rhabdomyosarcoma, etc.; 4. Thyroid related eye disease; 5. Uncontrollable infection, temperature >=38 degree C; 6. Uncontrolled hypertension; 7. Diabetes; Cardiovascular and cerebrovascular diseases; 8. Severe psychiatric disorders, central nervous system symptoms, epileptic seizures, metabolic diseases or electrolyte disorders; 9. Other diffuse connective tissue diseases and other immune diseases: ankylosis, systemic lupus erythematosus, behce's disease, etc.; 10. Any uncontrolled clinical problems: AIDS, malignant tumors, active hepatitis, tuberculosis, chronic stomach diseases, etc.; 11. Liver and kidney failure; 12. Respiratory and other systemic diseases; 13. Hematopoietic system lesions: the patient has coagulation mechanism disorder or is taking oral warfarin, clopidogrel and other similar drugs for anticoagulant therapy; 14. Screened for systemic hormone use 6 months prior to visit; 15. Patients with a history of immunosuppressive and cytotoxic drug treatment in the past 3 months; 16. Researchers with poor compliance or suffering from severe mental or language disorders cannot complete the clinical trial protocol; 17. Routine blood test: white blood cell count <3.0x10^9/L or (and) platelet count <50x10^9/L; 18. Has contraindications or a history of allergies and allergies to any component of the test drug, is allergic to two or more drugs and/or non-drug factors, or is suffering from an allergic disease; 19. Those who have participated in any drug clinical trial within 3 months before screening; 20. The investigator considers it inappropriate to participate in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| annualised relapse rate; | — |
Countries
China
Contacts
Public ContactShihui Wei
the First Medical Center of Chinese PLA General Hospital
Outcome results
None listed