Abstract: Objective To analyze the symptoms related to liver injuries induced by anti-tuberculosis drugs and liver injury in tuberculosis (TB) patients during treatment, and to evaluate the risk of anti-tuberculosis drugs induced liver injury (ATLI) in patients with these symptoms. Methods Relevant data in the database of “Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Control and Prevention Scheme Study” (ADACS), including information of follow-up calendars and outcome, were used to analyze the distribution of symptoms related to liver injury in 4065 new smear positive TB patients during treatment with first-line anti-tuberculosis drug and evaluate the risk of ATLI on patients with these symptoms. Results The proportion of TB patients had symptoms related to liver injury during treatment was 33.9% (1377/4065). Among whom 91.1% (1255/1377) experienced 1 to 3 symptoms, and 92.2% (1269/1377) developed symptoms in intensive phase. In patients with symptoms related to liver injury, the risk of liver injury and moderate or severe liver injury increased. The rates of liver injury in patients with fever, nausea, weakness, skin rash, abdominal discomfort, anorexia and other symptoms of ATLI were 7.4% (14/190), 13.3% (130/975), 10.1% (51/505), 10.8% (47/434), 14.5% (56/387), 77.4% (41/53) and 55.6% (15/27) respectively, while the rates of moderate or severe liver injury were 6.3% (12/190), 5.8% (57/975), 5.0% (25/505), 5.3% (23/434), 7.2% (28/387), 60.4% (32/53) and 48.1% (13/27) respectively. Patients with each symptom of above (except fever) had higher risk of liver injury and moderate or severe liver injury than those without the symptom. The relative risk of liver injury in patients with anorexia or other symptoms of ATLI was 13.4 (95%CI: 10.5-17.1) and 8.7 (95%CI: 5.7-13.2) respectively in comparison with patients without the symptom, and the relative risk of moderate or severe liver injury was 27.5 (95%CI: 21.2-35.7) and 18.2 (95%CI: 12.1-27.3) respectively. The relative risk of moderate or severe liver injury in patients with fever was 2.3 (95%CI: 1.3-4.0) compared with patients without fever. Conclusion One third of TB patients experience symptoms related with liver injury during treatment, and the symptoms mainly appear in intensive phase. Patients with nausea, weakness, skin rash, abdominal discomfort, anorexia and other symptoms of ATLI have a higher risk of liver injury. Fever may be the indicative symptom of moderate or severe liver injury, which needs to be further confirmed.

Key words: Tuberculosis, pulmonary/drug therapy, Antitubercular agents, Hepatitis, toxic