To investigate the difference in clinical characteristics of drug-induced liver injury (DILI) between patients of different gender.

Through the hospital electronic medical record system, clinical data of patients hospitalized because of DILI at Liver Research Center, Beijing Friendship Hospital, Capital Medical University from January 2005 to January 2021 were collected and retrospectively analyzed. The collected information included gender, age, body mass index, underlying diseases, medication, results of the first laboratory tests after admission, clinical manifestation and types of DILI, etc. The patients were divided into 2 groups according to gender and the clinical characteristics of DILI were compared. The factors affecting death/liver transplantation in DILI patients were analyzed by Cox regression method.

A total of 616 patients with DILI were entered, including 139 males (22.6%) and 477 females (77.4%). The median age was 56 (47, 64) years, ranging from 18 to 80 years. Drugs that caused DILI were traditional Chinese medicine and/or health care products (TCMHCP) in 345 patients (56.0%), western drugs in 148 patients (24.0%), and TCMHCP and western drugs in 123 patients (20.0%). Death/liver transplantation occurred in 42 patients (6.8%), including 3 liver transplantation, 19 death directly caused by the liver disease, and 20 death with causes other than liver disease. The incidences of dark urine and abdominal distension, severe liver injury, and death/liver transplantation in male patients were all higher than those in female patients, respectively [71.9% (100/139) vs. 60.0% (286/477), P=0.010; 28.8% (40/139) vs. 18.7% (89/477), P=0.010; 46.8% (65/139) vs. 40.5% (193/477), P<0.001; 15.1% (21/477) vs. 4.4% (21/139), P<0.001]. Laboratory test results such as the white blood cell count, hemoglobin, total bilirubin, direct bilirubin, total bile acid, triglyceride, and low density lipoprotein cholesterol in male patients were all higher than those in female patients, while the levels of pre-albumin, immunoglobulin G, immunoglobulin M, and serum creatinine were lower (all P<0.05). Cox regression analysis showed that male, older age, low albumin, high total bile acid, high serum creatinine, and prolonged international normalized ratio (INR) were the independent influencing factors of death/liver transplantation in patients with DILI.

Clinical manifestation are different in DILI patients of different gender hospitalized in the Liver Research Center, Beijing Friendshop Hospital, Capital Medical University. In male patients, cholestasis is more obvious, the disease condition is more serious, and death/liver transplantation is more common. Male patients and patients with older age, lower albumin, higher total bile acid, higher serum creatinine, and higher INR are more prone to death/liver transplantation, which should be paid attention to in clinic.

Liver; Drug toxicity; Sex factors; Disease attributes; Drug-induced liver injury; Risk factors