Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Hepatotoxicity
研究概览
简要总结
Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two sputum specimens positives for tubercle bacilli on direct smear microscopy
- •No previous anti-TB chemotherapy higher than two weeks
- •Aged 60 years and over
- •Agreement to participate in the study
排除标准
- •Alcohol consumption
- •Viral disease (Hepatitis,...)
- •Abnormal pretreatment LFT level
- •Chronic disease (liver and kidney disease, asthma,...)
- •Additional hepatotoxic drug use
- •HIV positive
- •Patient in a moribund state
- •Hemoptysis
结局指标
主要结局
Hepatotoxicity
时间窗: Two weeks
次要结局
未报告次要终点
