Abstract: Objective This clinical trial was conducted to observe combination of polyene phosphatidylcholine and silybin in treatment of patients with drug-induced liver injury (DILI) . Methods 102 patients with DILI were recruited in our hospital between January 2021 and July 2024, and the patients were randomly assigned to receive intravenous polyene phosphatidylcholine in control group (n=51) or receive intravenous polyene phosphatidylcholine and oral silybin capsules in observation group (n=51) for 2 to 4 weeks. Serum superoxide dismutase(SOD), malondialdehyde(MDA) and glutathione(GSH) levels were routinely obtained, and serum C-reactive protein (CRP), interleukin-6 (IL-6), IL-1β and tumor necrosis factor-α (TNF-α) levels were detected by ELISA. Results Normalization rates of liver function tests in our series was 91.2%, with slight liver function tests abnormal in 9 cases (8.8%); after treatment, serum ALT, AST and ALP levels in the observation group were (33.6±6.7)U/L, (35.8±7.1)U/L and (62.3±11.4)U/L, all significantly lower than [(47.9±7.4)U/L, (52.8±7.0)U/L and (73.1±11.9)U/L, respectively, P<0.05] in the control; serum SOD and GSH levels were 86.0(74.6, 93.2)U/L and (7.9±1.3)μmol/L, both much higher than [73.5(69.1, 81.2)U/L and 6.3±1.0)μmol/L, P<0.05], while serum MDA level was (5.2±1.1)nmol/L, much lower than [(6.4±1.2)nmol/L, P<0.05] in the control; serum TNF-α and IL-1β levels were (4.6±1.8)pg/mL and (11.3±4.4)ng/mL, both significantly lower than [(9.3±2.6)pg/mL and (26.4±6.7)ng/mL, respectively, P<0.05] in the control group. Conclusion The combination of polyene phosphatidylcholine and silybin could improve liver function test back to normal in patients with DILI, which might be related to inhibition of oxidative stress and cytokine release, and is worthy of further clinical observation.

Key words: Drug-induced liver injury, Polyene phosphatidylcholine, Silymarin, Superoxide dismutase, Cytokines, Therapy