Comparison of Adverse Reactions and Efficiency of Fixed-dose Combination Chemotherapy and Separate Formulations for Pulmonary Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
研究概览
简要总结
The fixed-dose combinations (FDC) with two or more antituberculous drugs in one capsule or tablet are available to prevent the development of drug resistance. However, the fixed-dose combination regimen is not consistent with the dosages that are usually given. The present available FDC chemotherapy (Rifater) for pulmonary tuberculosis that is used in Taiwan has a higher ratio of isoniazid to rifampin and pyrazinamide. The higher risk of drug toxicity and adverse reactions when using fixed-dose combinations regimen should be considered. The aim of the present study is to compare the toxicity between using FDC regimen (Rifater/Rifinah) in Taiwan and single drugs in the treatment of newly diagnosed pulmonary tuberculosis. The investigators also evaluate the efficacy of two regimens and determine the incidence of discontinuation of TB drugs and the predisposed factors between two regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Newly diagnosed pulmonary TB and extrapulmonary TB patients
- •No previous anti-TB drugs treatment
- •Age≥18years old
排除标准
- •Expected life < 6months
- •Baseline AST/ALT > 3x upper limit of normal (ULN)
- •Age <18years old
结局指标
主要结局
To compare the frequency of occurrence of adverse reactions between using FDC and single drugs in pulmonary tuberculosis treatment
时间窗: two year
次要结局
- To compare the efficacy of anti-TB treatment between using FDC and single drugs(two year)