Risk factors of anti-tuberculosis drugs induced liver injury and its impact on the treatment outcome of patients treated with first line anti-tuberculosis drugs: a historic retrospective cohort study

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Objective To explore the incidence and risk factors of anti-tuberculosis (TB) drugs induced liver injury (ATDILI) and to discuss its impact on the treatment outcome of patients treated with first line anti-TB drugs. Methods Among the patients who received anti-TB treatment with directly-observed treatment strategy (DOTS), 121 patients with ATDILI and 817 patients without ATDILI were included in this retrospective cohort study. Binary Logistic regression model was used to analyze the risk factors of ATDILI in univariate and multivariate analysis. The χ2 test was used to compare the treatment success rates and drug resistant rates. Kaplan-Meier analysis and Log-rank test were used to compare the sputum smear/culture conversion rates and cavity closure rates. Results The incidence of ATDILI was 12.9%(121/938) in this cohort. Multivariate Logistic regression showed that hepatitis B virus carrier with both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) positive (OR=4.29, 95%CI: 2.15-8.58, P 0.05). The sputum smear/culture conversion rate (85.4%[41/48] vs 94.0%[298/317], χ2=38.912, P<0.01) and cavity closure rate (84.6%[22/26] vs 93.0%[198/213], χ2=20.709, P<0.01) in patients with ATDILI were both significantly lower than those in patients without ATDILI. Conclusions The incidence of ATDILI is relatively high in hospitalized patients treated with first line anti-TB drugs. ATDILI has negative effects on treatment outcome of TB patient. Hepatitis B carrier with positive HBsAg and HBeAg, systemic lupus erythematosus, albumin ≤25 g/L and alcoholism may increase the risk of developing ATDILI. Key words: Antitubercular agents; Liver injury; Risk factor; Treatment outcome; Historical cohort study