Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Number of Participants with GD relapse
研究概览
简要总结
The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:
- To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
- To determine an optimal cut-off of TSI level for predicting GD relapse.
- To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.
详细描述
Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
- •TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.
排除标准
- •Hyperthyroidism due to other causes
- •Patients who were intolerant to ATD or had serious side effects with ATD.
- •TSIs were measured in pregnancy.
- •Patients treated with surgery or radioactive iodine.
结局指标
主要结局
Number of Participants with GD relapse
时间窗: at least 1 year after ATD withdrawal
Patients who had relapse of hyperthyroidism due to GD
次要结局
- TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.(before ATD withdrawal)
- Optimal cut-off of TSI level for predicting GD relapse(before ATD withdrawal)
研究者
Phong VN Nguyen
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City