HU Bo-lin, BU Zi-qing, ZHU Mei, QIU Sheng-hua
Objective: To explore the clinical characteristics of adverse drug reactions (ADRs) induced by colchicine using China Hospital Pharmacovigilance System (CHPS), and provide a reference for the safe use of colchicine in clinical practice. Methods: Using CHPS, patients who used colchicine in the First People's Hospital of Qinzhou from January 2021 to December 2022 were selected as the research objects. The occurrence of ADRs after colchicine use was statistically analyzed, and a correlation evaluation was conducted. Information such as patient age, gender, ADR occurrence time, clinical manifestations, and outcome was collected to analyze the clinical characteristics of colchicine-related ADRs. Results: A total of 2 008 patients who used colchicine were retrieved through CHPS, among which 133 cases were reported of ADRs, with an incidence rate of ADRs at 6.62%. According to the classification and evaluation criteria for ADR causality of WHO-UMC, the vast majority had a "probable" association with colchicine (119 cases, 89.47%). Among 133 patients with colchicine-related ADRs, males were far more than females (120 cases vs 13 cases), and middle-aged and elderly patients aged not below 45 were the main group (117 cases, 87.97%). Most of 133 colchicine-related ADRs occurred within the first five days of colchicine use (116 cases, 87.22%), with diarrhea being the most common clinical manifestation (120 cases, 90.23%), followed by abdominal pain (12 cases, 9.02%). Among 133 ADR patients, most adopted the strategies of discontinuing colchicine and using montmorillonite powder (56 cases, 42.11%) and simply discontinuing colchicine (47 cases, 35.34%). After treatment, ADRs of all patients gradually disappeared, and related indicators returned to normal. Conclusion: As a drug with a narrow therapeutic window, colchicine has a high incidence rate of ADRs, especially in middle-aged and elderly patients. Clinicians should strengthen the monitoring of medication safety in related patients, such as using CHPS, to ensure medication safety of patients.