BACKGROUND: A Chinese population-based study aimed to investigate the risk factors for the incidence and severity of drug-induced liver injury (DILI) from Chinese herbal medicines and conventional Western medicines.

MATERIAL AND METHODS: Liver biopsy and routine laboratory testing, including serum lipid measurements, was performed on 465 patients, including 168 patients with DILI and 297 patients without DILI. Histological grading of DILI used the METAVIR scoring system and the severity of DILI was graded as levels 0–5. Multivariate and univariate regression analysis were used to compare the two study groups, using a risk-adjusted odds ratio (AOR).

RESULTS: There was no significant association between age, alcohol status, cardiovascular disease (CVD), hypertension, or type 2 diabetes mellitus and development of DILI. However, when compared with controls, patients with dyslipidemia (AOR, 2.173; 95% CI, 1.388–3.401; P=0.001) had an increased incidence of DILI, and men had a reduced incidence of DILI when compared with women (AOR, 0.276; 95% CI, 0.169–0.450; P<0.001). Risk factors for severe DILI (≥level 3) included drinking alcohol (AOR, 6.506; 95% CI, 2.184–19.384; P=0.001), and dyslipidemia (AOR, 3.095; 95% CI, 1.345–7.123; P=0.008). Patients with an increased duration of drug treatment of >1 year had a reduced risk of developing severe DILI compared with patients with a medication duration of ≤1 month (AOR, 0.259; 95% CI, 0.084–0.802).

CONCLUSIONS: Increased risk of the incidence of DILI was significantly associated with female gender and dyslipidemia, and the risk of developing severe DILI was associated with drinking alcohol and dyslipidemia.

Keywords: drug-induced liver injury, dyslipidemias, Risk Factors, Asians, Incidence, Lipids, Liver, Odds Ratio, Severity of Illness Index