A Prospective Clinical Follow-up Study of Drug Treatment in Patients With Graves' Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Relapse and remission of Graves' disease in adult treated with methimazole.
研究概览
简要总结
This study was a prospective follow-up study of newly diagnosed and relapsed Graves' disease patients in the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The following aspects will be studied: 1. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software; 2. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment; 3. To investigate the sensitivity and specificity of TRAb in the diagnosis of GD in China and its role in predicting recurrence; 4. After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •Newly diagnosed GD and GD relapses.
排除标准
- •Patients with active infiltrative exophthalmos in GD were excluded.
- •Patients with other autoimmune diseases affecting thyroid function were excluded.
- •Excluding patients with combined malignancies and other serious diseases.
结局指标
主要结局
Relapse and remission of Graves' disease in adult treated with methimazole.
时间窗: 30 years
Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software.
Adverse effects of methimazole in the treatment of Graves' disease in adult.
时间窗: 30 years
Adverse effects are defined as having neutropenia (absolute neutrophil count\< 1800/µL), liver dysfunction (AST or ALT\> 60 IU/L), rash, arthralgia, myalgia, et al. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment
次要结局
- Thyrotropin receptor antibody(TRAb)(30 years)
- The serum alkaline phosphatase(30 years)
研究者
Xiaochun Teng
Chief Physician
First Hospital of China Medical University