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临床试验/NCT01204359
NCT01204359Unknown3 期

"5010 Clinical Research Programme"of Sun Yat-sen University

Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 627 人开始时间: 2007年7月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
627
试验地点
2
主要终点
The rate of Hypothyroidism after Iodine 131 treatment

研究概览

简要总结

Iodine 131 (131I) treatment on Graves disease and Graves ophthalmopathy relationship has always been the focus of debate. Majority view is that the current treatment does not increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is not a contraindication of 131I treatment. While treatment with corticosteroids, a timely corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But the merger with severe proptosis in patients with Graves , especially infiltrative exophthalmos , the application of 131I treatment will induce or aggravate not yet reached consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective study and visual assessment is not lack of uniform standards, and a variety of factors (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment or not, how to dose adjustments, and the use of which required treatment with systemic issues such as research, explore treatment exophthalmos reduction and mitigation of increased proptosis reasonable treatment of symptoms. To further promote the standardization of 131I treatment of Graves disease on basis.

详细描述

no more description

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
8 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed.

排除标准

  • 131I treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy

结局指标

主要结局

The rate of Hypothyroidism after Iodine 131 treatment

时间窗: one year

次要结局

  • The side effect to Infiltrative exophthalmos after Iodine 131 treatment(one year)

研究者

发起方
Sun Yat-sen University
申办方类型
Other

研究点 (2)

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