Analysis on 22 605 ADR/ADE associated with anti-infective agents in military hospitals

Abstract：Objective:To analyze adverse drug reaction reports and events (ADR/ADE) of anti-infective drugs in military hospitals in order to investigate the characteristics and regular pattern of anti-infective ADR/ADE.Methods:A total of 22 605 ADR/ADE of anti-infective drugs were collected retrospectively from 2009 to 2013 in the database of PLA ADR monitoring center. Age and gender of patients, drug category, administration route, dosage form, systems/organs involved and clinical manifestation, relevance evaluation and prognosis were analyzed.Results:Among 22 605 ADR/ADE, ratio of males and females was 1.06:1. The average age was (43.67 ± 22.56) years. The main administration route and dosage form were intravenous drip and injection respectively. A total of 180 kinds of anti-infective agents in 22 categories were related. The top three categories of antibiotics were quinolones (6887 cases, 30.47%), cephalosporins (4044 cases, 17.89%),β-lactamase inhibitor and its compound preparation (2832 cases, 12.53%). The top three antibiotics were levolfoxacin (2910 cases, 12.87%), azithromycin (1800 cases, 7.96%) and gatilfoxacin (1576 cases, 6.97%). Many systems/organs (35 495 frequencies) were involved in 22 605 ADR/ADE, in which the most common is the skin and its appendages damage (14 492 cases, 40.83%) followed by the gastrointestinal system damage (7128 cases, 20.08%) and systemic damage (3707 cases, 10.44%).Conclusion: Anti-infective drugs associated ADR/ADE involved different ages, various drug categories and multiple systems/organs. In order to recognize and treat ADR/ADE in time, risk precaution should be strengthened during the use of anti-infective agents.