The Effect of Hydroxychloroquine Treatment in Hashimoto's Thyroiditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anti-TPO antibody
研究概览
简要总结
Hashimoto's thyroiditis is an autoimmune thyroid disease, which induced chronic inflammation of thyroid gland and destroys thyroid tissue.
Hydroxychloroquine is used as disease modifying anti-rheumatic drug (DMARD) for treatment of several autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis(RA) for more than one century.
The purpose of this study is to evaluate whether hydroxychloroquine is effective in treatment of Hashimoto's thyroiditis.
详细描述
Hashimoto's thyroiditis is an autoimmune thyroid disease, and when the disease progresses, thyroid function finally declined to hypothyroidism.
There was no medical treatment recommended for patients with Hashimoto's thyroiditis, but currently at euthyroid state. Levothyroxine replacement therapy starts if patients become hypothyroid state.
Hashimoto's thyroiditis is a T-cell mediated autoimmune thyroid disease. The major auto-antigens include thyroid peroxidase (TPO) and thyroglobulin. Anti-TPO antibodies induce antibody-dependent cell-mediated cytotoxicity (ADCC) and cause destruction of thyroid tissues.
Antimalarial agents like hydroxychloroquine have several pharmacologic effects which may be involved in the treatment of rheumatic diseases, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, nicotinamide adenine dinucleotide hydrogen-cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosome membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis.
This study is to investigate the treatment effect of hydroxychloroquine on autoantibodies and disease progression of Hashimoto's thyroiditis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hashimoto's thyroiditis
- •Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit)
- •Never receive immunomodulators or immunosuppressants
排除标准
- •Planned pregnant or already pregnant women
- •Renal insufficiency
- •Hepatic insufficiency
- •Agranulocytosis
- •Thrombocytopenia
- •Glucose-6-phosphate dehydrogenase deficiency
- •Porphyria cutaneous tarda
- •Allergy to 4-aminoquinolone
研究组 & 干预措施
Hydroxychloroquine
Receive treatment with hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Anti-TPO antibody
时间窗: 6th month after medical treatment
Check anti-TPO antibody 6 months after medical treatment as inflammatory marker
Anti-thyroglobulin antibody
时间窗: 6 months after medical treatment
Check serum anti-thyroglobulin antibody 6 months after medical treatment as inflammatory status
次要结局
- Elasticity of thyroid gland(6 months after medical treatment)
- Thyroid function(6 months after medical treatment)
- Inflammatory cytokines(6 months after treatment)