Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Prevalence of hepatitis at 8 weeks
研究概览
简要总结
To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).
详细描述
Tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-TB drug was observed for 5-28%. Slow acetylator status in the N-acetyltransferase 2 (NAT2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (AT-DILI). We assessed the effect of N-acetylcysteine to prevent hepatitis from anti-TB drug in Thai population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed TB
- •Received standard dose of anti-TB drugs regimen (National Tuberculosis Control Programme guideline Thailand 2018)
- •Aged ≥18 years
- •Informed consent
排除标准
- •Previous TB infection or MDR TB
- •Allergy to NAC
- •Abnormal baseline LFT
- •(AST or ALT>2.5 times UNL, ALP> 2 times UNL, TB> 1.5 mg/dl)
- •Chronic hepatitis B, C infection
- •Decompensated cirrhosis
- •HIV infection
- •Active malignancy
- •Pregnancy or lactation
- •Severe co-morbidity i.e. severe heart diseases, severe lung diseases, ESRD
研究组 & 干预措施
NAC group
Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C using NAC-long 1,200 mg/day for 8 weeks (NAC long group). Genetic test (acetylator status of NAT2), CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks.
干预措施: N acetyl cysteine (Drug)
结局指标
主要结局
Prevalence of hepatitis at 8 weeks
时间窗: 8 weeks
To study efficacy of NAC to prevent anti-TB drug induced liver injury. Outcome was measured events of hepatitis occurred at 8 weeks, compared between NAC versus controlled group, presented by total number and percent. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels.
次要结局
- Prevalence of hepatitis among NAT2 slow acetylator patients(8 weeks)
研究者
Watcharasak Chotiyaputta
Associate professor, Faculty of Medicine, Siriraj Hospital Affiliation: Mahidol University
Mahidol University