An Investigation of the Risk Factors Associated With Anti-Tuberculosis Drug-Induced Liver Injury or Abnormal Liver Functioning in 757 Patients With Pulmonary Tuberculosis.

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. 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. 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 ( <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) ( = 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 ( = 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. 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.