Role of N-acetylcysteine(NAC) in preventing development of anti tuberculosis therapy(ATT) induced liver injury in pulmonary tuberculosis(PTB) patients, a simple randomized single blind clinical trial

Abstract

Background: ATT is associated with increased risk of liver injury in PTB patients. NAC reduces the chances of drug induced liver injury(DILI) Aim and Objective: To find out if NAC is useful in preventing ATT induced liver injury in PTB patients or not Material and Method: A randomized clinical trail conducted on 162 newly diagnosed PTB patients having age between 18-60 years at OICD Karachi. Patients were randomized into two groups, a control group in which only standard ATT was used and a trail group in which standard ATT regimen and NAC 600mg twice daily was used. Patients followed for 2 months. Baseline laboratory tests including aspartate aminotransferase(AST), alanine aminotransferase(ALT) and bilirubin were evaluated before starting ATT,at the end of 2 weeks,at the end of 2 months or whenever patient was symptomatic of liver injury Results: Out of 169 enrolled patients 7 dropped out,162 completed the study protocol. 54.3% patients were male and 45.7% were female. Liver injury occurred in 14/81(17.3%) in control group and 1/81(1.2%) in trial group. Most of the liver injury was noted in 2nd week of ATT. AST, ALT and bilirubin were found deranged. It was common 10 (66.7%) in age group 50-60 years. Reported symptoms of liver injury were anorexia in 10 (66.7%), nausea and vomiting in 7 (46.7%), abdominal pain in 2 (13.3%) and jaundice in 3 (20.6%)patients in control group whereas 1 patient of trial group was asymptomatic. Conclusion: NAC is effective in preventing ATT induced liver injury. Method: Liver injury, Pulmonary tuberculosis, Anti tuberculosis therapy, N-acetylcysteine.