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临床试验/NCT00917241
NCT00917241已完成4 期

Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone

Xiao-Ming Mao0 个研究点目标入组 218 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
218
主要终点
relapse of hyperthyroidism

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed of Graves' Disease

排除标准

  • 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.

研究组 & 干预措施

MMI+IID group

Experimental

MMI,methimazole;IID,intrathyroid injection of dexamethasone

干预措施: MMI combined with IID (Drug)

MMI Group

Active Comparator

MMI,methimazole

干预措施: MMI (Drug)

结局指标

主要结局

relapse of hyperthyroidism

时间窗: 4.5 year

次要结局

未报告次要终点

研究者

发起方
Xiao-Ming Mao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiao-Ming Mao

Professor

Nanjing Medical University

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