Retractable Graves Disease and Ophthalmopathy
Conditions
Interventions
A:Antithyroid drug monotherapy
B:Rapamycin monotherapy
C:Rapamycin combined with antithyroid drug treatment
Sponsors
First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria of part 1: detecting the expression of mTOR signalling proteins in peripheral blood mononuclear cells of patients with retractable GD or GO: 1) retractable GD patients: those who are unable to withdraw drug treatment or with persistently positive TRAB despite on regular antithyroid drug treatment for more than 5 years; 2) GD patients in remission: those who achieve withdrawal criteria after regular antithyroid drug treatment within 1 to 2 years, and remain in remission for more than 1 year after drug withdrawal; 3) healthy controls: age- and sex-matched healthy participants; 4) retractable GO patients: those who are resistant to conventional glucocorticoid pulse therapy; 5) GO patients in remission:NO SPECS and CAS scores show remission after conventional glucocorticoid pulse therapy. Inclusion criteria of part 2: investigating the clinical and immunological efficacy of rapamycin on patients with retractable GD: 1) diagnosis of retractable GD through medical history, thyroid function tests, TRAB measurement and thyroid sonography; 2) intake of anti-thyroid drug(Methimazole) 5-15 g per day; 3) normal T3 and T4 levels; TSH below 0.07uIU/mL.
Exclusion criteria
Exclusion criteria: 1) Hyperlipidemia, hypertension, hyperglycemia, or other major co-morbidity; 2) Leukopenia, infection or thrombosis, active hepatitis; 3) serious heart, liver or kidney disease, cancer, or other autoimmune diseases; 4) treatment with immunomodulatory drugs; 5) pregnant,breast-feeding or unborn women; 6) aged below 18 or above 60 years old; 7) no informed concents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of participants with normal TSH levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| the average time needed for TSH level to return to normal;thyroid volume;TRAB titre; | — |
Countries
China
Contacts
Public ContactBingyin Shi
First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed