Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone|
- relapse of hyperthyroidism [ Time Frame: 4.5 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Study Completion Date:||March 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: MMI+IID group
MMI,methimazole；IID,intrathyroid injection of dexamethasone
Drug: MMI combined with IID
MMI titration regimen for 18 months,initial dosage of MMI was 20 mg/d,which combined with IID for 3 months.Dexamethasone was injected into the two side of thyroid, the dose of dexamethasone was 5 mg by every side, twice a week. The treatment strategy was changed to once a week at the second month and twice a month at the third month, the dose of dexamethasone was the same as the first month.
Other Name: methimazole,tapazole;dexamethasone,hexadecadrol
Active Comparator: MMI Group
MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.
The morbility of GD is nearly 0.5% and the underlying cause of 50 to 80% of cases of hyperthyroidism.Recently,anti-thyroid drugs are still the main therapy for Graves'hyperthyroidism in a lot of districts, but the relapse rate is very high (51~68%) after withdrawal of anti-thyroid treatment.In order to reduce the relapse rate, some studies tried to prescribe replacement thyroxine, either with the anti-thyroid drug treatment, or after this was completed, but there is no clear evidence in favour of giving thyroid hormone supplementation following the initial treatment of Graves' thyrotoxicosis with anti-thyroid medication. Therefore, the optimal medical therapy for Graves' hyperthyroidism remains a subject of debate.
It is well known that glucocorticoids have anti-inflammatory, immunomodulation and immunosuppression effects and they has long been used to treat GO, and is one of the most effective medicine ,it can decrease some cytokines and reduce inflammatory status ,and improve some thyroid specific antibody, like as thyrotropin receptor antibodies (TRAb), antithyroperoxidase antibodies (TPOAb) and antithyroglobulin antibodies (TGAb).These studies suggested that glucocorticoids might affect autoimmune process and have some benefit effects on GD. Moreover glucocorticoids have been used to treat GD in several early reports, in which serum free triiodothyronine (FT3) and thyroxine (FT4) or total T3(TT3) and TT4 levels decreased after 8 days or three weeks treatment with glucocorticoids . But in those studies, the number of selected patients is small, and the duration of the therapy is relatively short, so that might not confirm the effects of glucocorticoids on GD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917241
|Principal Investigator:||Xiaoming Mao, M.D.||Affiliated Nanjing First Hospital, Nanjing Medical University|