Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Graves' Disease |
Drug: MMI combined with IID Drug: MMI |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 218 |
| Study Start Date: | June 2004 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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,methimazole
|
Drug: MMI
MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed of Graves' Disease
Exclusion Criteria:
- Pregnancy
- Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST) above 2 times of upper normal range
- Non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study.
Contacts and Locations More Information
No publications provided by Nanjing Medical University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Xiao-Ming Mao, Professor, Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT00917241 History of Changes |
| Other Study ID Numbers: | NanjingMU |
| Study First Received: | June 9, 2009 |
| Last Updated: | May 2, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Nanjing Medical University:
|
Graves' disease dexamethasone relapse methimazole |
Additional relevant MeSH terms:
|
Graves Disease Exophthalmos Orbital Diseases Eye Diseases Goiter Thyroid Diseases Endocrine System Diseases Hyperthyroidism Autoimmune Diseases Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Methimazole BB 1101 |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013