To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
82
N acetyl cysteine 1,200 mg/day for 8 weeks in NAC group
Faculty of Medicine, Siriraj Hospital
Bangkok, Thailand
RECRUITINGPrevalence of hepatitis at 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.
Time frame: 8 weeks
Prevalence of hepatitis among NAT2 slow acetylator patients
To study efficacy of NAC to prevent anti-TB drug induced liver injury among NAT2 slow acetylator patients. Outcome was measured events of hepatitis occurred at 8 weeks among NAT2 slow acetylator patients 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.
Time frame: 8 weeks
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