The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- successful re-use of isoniazid for TB treatment
研究概览
简要总结
To improve the treatment outcome in patients with tuberculosis and integrate the pharmacogenetics into clinical practice, the information of NAT2 genotyping was used in re-challenge protocol for isoniazid (INH) titration in patients with anti-tuberculosis medication-induced hepatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •>= 18 years.
- •Take INH for at least a week.
- •abnormal liver function (ALT (alanine, transaminase) increased by more than three times the upper limit of normal, or ALT higher than twice the upper limit of normal and total bilirubin higher than 2.0 mg / dL
排除标准
- •1.Taking INH before liver function abnormalities. 2.
研究组 & 干预措施
isoniazid rechalleng
When patients encountered hepatotoxicity during the anti-TB treatment, genotyping and pk study of INH would be performed and dose adjustment accordingly.
干预措施: isoniazid (Drug)
结局指标
主要结局
successful re-use of isoniazid for TB treatment
时间窗: 6 months
In this study, we would like to test the hypothesis of NAT2 genotyping helping in isoniazid rechallenge after patients experienced adverse effects of anti-TB treatment. Therefore, to observe the patients can re-use isoniazid successfully is an important outcome measure in this study.
次要结局
未报告次要终点