Abstract: Objective  In order to provide evidence for developing policy on expansion of fixed-dose combination (FDC) anti-TB drugs in China, FDC-associated liver injuries were evaluated. Methods  In 2011 and 2012, five provinces, including Gansu, Hebei, Jilin, Sichuan and Shandong, were involved in the evaluation. In each province, one prefecture was selected as the study site. All new pulmonary tuberculosis (PTB) patients notified from 1 July to 31 December 2011 were recruited in the study and FDC was used for treatment. EpiData 3.1 software was used for data entry and validation, and SPSS 16.0 was used for statistical analysis. The following data or information were collected and analyzed: time of getting liver damage and extent of liver damage, correlations between clinical symptoms and laboratory abnormalities, methods for dealing with liver damage (such as adjustment of treatment regimen and its influence to treatment outcomes). The value of P<0.05 was regarded as statistically significant difference.  Results  A total of 5981 PTB patients were enrolled in this study and 14.4% (862/5981) of them got abnormal liver function during treatment with FDC, including 2.4% (145/5981) of enrolled patients had abnormal alanine aminotransferase, 4.0% (241/5981) of enrolled patients had abnormal total bilirubin and 11.9% (714/5981) of enrolled patients had abnormal direct bilirubin. Among the patients who got abnormal liver function, 56.1% (484/862) of them had moderate or severe liver damage and it occurred within 1 month of treatment in 57.2% (277/484) of patients. Ten point three percent (619/5981) of enrolled patients showed clinical symptoms of adverse reaction in digestive system. Data from the patients who had digestive reactions and abnormal liver function were compared and the results showed that: there was no significant difference between digestive reactions and abnormal DBIL (χ²=1.1382, P>0.05); however, there were significant difference between digestive reactions and TBIL (χ²=14.3116, P<0.05), digestive reactions and ALT (χ²=19.4849，P<0.0001). The treatment was adjusted in 23.1% (112/484) of patients who had moderate or severe liver damage, namely FDC was replaced by loose drugs.  Conclusion  During treatment with FDC, the attention should be paid to liver injury.Patients who got moderate or severe liver injury,FDC should be replaced by loose drugs.

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