Abstract: Objective To analyze the clinical manifestations, imaging features and prognosis of patients with drug-induced cholestatic liver injury. Methods Between March 2020 and March 2022, our hospital diagnosed 47 patients with drug-induced cholestatic liver injury, comprising 29 males and 18 females, with an average age of 55.5±7.1 years. We analyzed the patients age, medication history, clinical manifestations, causative drugs, and imaging findings. Additionally, we compared clinical data based on different prognostic outcomes and identified factors influencing prognosis. Results Among 47 patients diagnosed with pharmacological cholestatic liver injury, age distribution was aas follows: 3 patients(6.4%) were under 40 years old, 23 patients(48.9%) were between 40-60 years old, and 21 patients(44.7%) were over 60 years old. The duration of medication ranged from 3 to 150 days, with a median of 13 days(IQR 3, 25days).Tthe latency period varied from 2 to 180 days, with a median of 21 days(IQR 10, 32days). 42 patients (89.4%) exhibted one or more clinical symptoms, while 5 patients (10.6%) displayed only liver function abnormalities without conscious symptoms. Among the causative agents, a total of 74 drugs were identified, with 31 patients (65.9%) being exposed to more than one causative drug. The top five categories of drugs included Chinese herbs(21 cases, 44.7%), antimicrobials(16 cases, 34.0%), anti-tuberculosis drugs(14 cases, 29.8%), digestive system drugs(13 cases, 27.6%), and antitumor drugs(7 cases, 14.9%). Disease severity was categorized into four levels: level 1 (19 cases, 50.0%), level 2(17 case, 44.7%), level 3 (6 cases, 15.8%), and level 4(5 cases, 13.1%). 30 patients (63.8%) underwent magnetic resonance cholangiopancreatography(MRCP), while the remaining patients underwent B-ultrasound or abdominal CT examination. Imaging revealed sclerosing cholangitis-like changes in 10 patients (21.3%), including extrahepatic strictures (5 cases, 10.6%), strictures of both intrahepatic and extrahepatic bile ducts(3 cases, 6.4%), and hilar bile duct strictures(2 cases, 4.2%). By October 2023, of the 47 patients, 27 were cured (62.5%), 11 showed improvedment (20.0%), 7 had poor outcomes(12.5%) and 2 died (5.0%), resulting in a total effective rate of 82.5%. Patients were divided into an effective group (cured and improved, n=38) and an ineffective group( poor and deceased, n=9). The clinical and laboratory parameters showed significant differences between the effective and ineffective groups. In the effective group, the age, RUCAM score, WBC, PLT, initial ALP, initial TBil, peak ALP, peak TBil and presnece of sclerosing cholangitis-like changes were 53.5±7.0 years, 8 (IQR 7, 9) points, 5.0 (IQR 3.9, 7.5) × 10⁹/L, 227 (IQR 170, 278) ×10⁹/L, 401.6±37.2 U/L, 126.5±21.3 μmol/L, 436.0±37.2 U/L, 146.3±35.6 μmol/L, and 4 cases (10.5%), respectively. In the ineffective group, these parameters were 62.4±11.3 years old, 6 (IQR 6, 7) points, 7.4 (IQR 5.0, 9.3) × 10⁹/L, 130 (IQR 98, 155) × 10⁹/L, 503.4±54.0 U/L, 150.2±47.0 μmol/L, 634.5±82.6 U/L, 181.2±64.5 μmol/L, and 6 cases (66.7%), respectively, with all the differences being statistically significant (P<0.05). In terms of disease severity, the distribution in the effective group was as follows: level 1, 17 cases (44.7%); level 2, 16 cases (42.1%); level 3, 3 cases (7.9%); and level 4, 2 cases (5.3%). In the ineffective group, the distribution was: level 1, 2 cases (22.2%); level 2, 1 case (11.1%); level 3, 3 cases (33.3%); and level 4, 3 cases (33.3%), with statistically significant differences(P<0.05). Conclusion Most patients with drug-induced cholestatic liver injury have a good prognosis; however, close attention should be paid to those with a low RUCAM score, high peak ALP, high peak TBil, and severe disease.

Key words: Pharmacologic, cholestatic, Liver injury, Clinical presentation, Imaging features, Regression