Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
Condition: Graves' Disease
MeSH terms: Graves Disease; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy
      withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of
      intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with
      newly diagnosed GD.
    

Detailed description: 
      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.
    

Intervention name(s): MMI combined with IID; MMI
Intervention type(s): Drug; Drug
Intervention description(s): 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.; MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.
Other intervention name(s): methimazole,tapazole;dexamethasone,hexadecadrol
Intervention MeSH terms: Dexamethasone; Methimazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graves' disease; dexamethasone; relapse; methimazole