An investigation of the risk factors associated with anti-tuberculosis drug-induced liver injury or abnormal liver functioning in 757 patients with pulmonary tuberculosis.

Objectives: To identify the risk factors associated with anti-tuberculosis drug-induced liver injury (AT-DILI) or abnormal living functioning from 757 patients with pulmonary tuberculosis (TB) registered at Nanshan Center for Chronic Disease Control (Nanshan CCDC), Shenzhen, Guangdong Province, China. Design and methods: We identified 757 TB patients who met our inclusion criteria by screening the Hospital Information System (HIS) at Nanshan CCDC. Next, we identified positive cases of AT-DILI or abnormal liver functioning based on results of the first-time liver function tests (LFTs) after taking anti-TB drugs. The χ2 test was used to relate the positive rate with a variety of factors. A logistic regression model was also used to identify statistically significant risk factors. Results: Of the 757 patients, the positive rate of AT-DILI or abnormal liver functioning was 37.9% (287/757). Univariate analysis revealed that the positive rate was 42.91% (212/494) for males and 28.52% (75/263) for females. The positive rate was significantly higher in males (p <0.001). Patients with an annual income of 9,231-13,845 USD had a significantly higher positive rate (67.35%; 33/49) than those with an income of 1,540-4616 USD (37.97%; 30/79) (p = 0.022). The most frequent prescription regime among positive cases was a 2 months supply of fixed dose combination Ethambutol Hydrochloride, Pyrazinamide, Rifampicin and Isoniazid Tablets (Ⅱ) 450 mg) followed by a 4 months supply of fixed dose combination Rifampin and Isoniazid Capsules (2FDC-HRZE half/4FDC-HR) at 56.03% (144/257). The least frequent prescription regime was a 2 months supply of fixed dose combination Rifampin, Isoniazid and Pyrazinamide Capsules with Ethambutol independently followed by a 4 months supply of fixed dose combination Rifampin and Isoniazid Capsules (2FDC-HRZ + EMB/4FDC-HR) at 24.27% (25/103). The difference between these two different regimes was significant (p = 0.022). With an increase in the duration of medication, patients under various prescription regimes all showed a gradual increase in the positive rate of AT-DILI or abnormal liver functioning. Conclusion: We identified several risk factors for the occurrence of AT-DILI or abnormal liver functioning, including gender, annual income, prescription regime, dosage, and treatment time.