A Retrospective and Prospective Observational Study of Hyperthyroidism in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months.
研究概览
简要总结
This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 29 Days 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤14 years old
- •Initial diagnosis of hyperthyroidism
排除标准
- •Hyperthyroidism had been treated with medication in other hospitals,
- •History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation,
- •Patients with incomplete clinical data
结局指标
主要结局
Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months.
时间窗: 10 years
To analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment.
Adverse effects of methimazole in the treatment of hyperthyroidism in children. Adverse effects are defined as having neutropenia (absolute neutrophil count< 1500/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al.
时间窗: 1 year
Analyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions.
次要结局
- Relapse of hyperthyroidism in children treated with methimazole. Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole.(10 years)
研究者
Shi Tang
Attending Physician
Shengjing Hospital