Role of bicyclol in preventing drug-induced liver injury in tuberculosis patients with liver disease.

Setting: Four hospitals in China.
Objective: To evaluate the clinical efficacy and safety of using bicyclol in conjunction with glucurolactone in preventing drug-induced liver injury (DILI) in tuberculosis (TB) patients suffering from underlying liver disease.
Design: A total of 240 initially treated TB patients who were healthy hepatitis B carriers or had pure steatosis were randomised into two equal groups; both received an oral glucurolactone tablet 600 mg/day (200 mg three times daily) as basic liver protection. The test group also received 75 mg/day (25 mg three times daily) bicyclol tablets orally, while the control group received no other liver protection. The incidence of liver injury in the two groups, the adjustment or termination of anti-tuberculosis chemotherapy and any adverse reactions were assessed.
Results: The incidence rate and level of severity of liver injury and the termination rate of anti-tuberculosis treatment in the test group were lower than that of the control group (P < 0.05). The overall time of occurrence of liver injury was significantly different between the two groups (P < 0.05).
Conclusion: Adding bicyclol to basic liver protectants may effectively and safely prevent the occurrence of anti-tuberculosis DILI in patients with underlying liver disease, and help simplify anti-tuberculosis treatment.