Abstract: Objective The aim of this study was to investigate the prevention of drug-induced liver injury(DILI) by orally diammonium glycyrrhetate in naïve patients with pulmonary tuberculosis (PT). Methods A multi-centered, open, randomized, parallel controlled clinical trial was conducted in 14 specialized tuberculosis hospitals in China, and 933 patients with PT were recruited and randomly divided into observation (n=495) and control (n=438), receiving six month 2HREZ/4HR regimen. The patients in the observation received diammonium glycyrrhetate enteric-coated capsules during anti-tuberculosis chemotherapy, whilethose in the control group didn't receive any hepatoprotectants. Results During the anti－tuberculosis therapy, the incidence of DILI in our series of 933 patients was 31.9%, and of which, that was 27.7% in the observation, significantly lower than36.8%(P<0.05) in the control; the incidence of regimen change owing to DILI in the observation was 3.2%, significantly lower than 7.8%(P<0.05) in the control; at the end of six month therapy, thesputum smear negative rates were 91.8% and 92.2%(P>0.05) in the two groups; the incidences of side effects other than DILI were 25.4% and 30.7%(P=0.054) in the two groups. Conclusion Our findings suggest that the preventive administration ofdiammonium glycyrrhetate could reduce the incidence of DILI during anti-tuberculosis treatment, which might keep the regimen going smoothly.

Key words: Drug-induced liver injury, Pulmonary tuberculosis, Anti-tuberculosis treatment, Diammonium glycyrrhetate, Prevention