Analysis on 1175 cases of serious adverse drug reaction and events associated with anti-infective agents from military hospitals

ZHU Man; FAN Chao; GUO Dai-hong; ZHAO Su-yu; MA Liang; CHEN Chao; XU Yuan-jie; ZHAO Peng-zhi; ZHAO Liang

Abstract：Objective:To investigate the characteristics of serious adverse drug reaction and events (ADR/ADE) related to anti-infective agents, and provide references for the clinical rational drug use.Methods:A total of 1175 serious ADR/ADE of anti-infective agents were collected from the database of PLA ADR monitoring center from 2009 to 2013. The data in respect of age and gender of patients, categories of suspected anti-infective drugs, route of administration, dosage form, systems and organs involved and clinical manifestations, relevance evaluation and prognosis were analyzed retrospectively.Results:The male to female ratio was 1.58 : 1, the average age of the patients was (49.62 ± 24.57) years, and the main route of administration was intravenous drip. Among suspected drugs, quinolones (195 cases, 16.60%), cephalosporins (184 cases, 15.66%),β-lactamase inhibitor and its compound preparations (159 cases, 13.53%) ranked the top three positions in terms of ADR/ADE frequency. The ADR/ADE were related to 124 kinds of anti-infective agents, levolfoxacin related reports were 73 cases (6.21%), followed by moxilfoxacin (64 cases, 5.45%) and linezolid (59 cases, 5.02%). The 1175 cases of serious ADR/ADE mainly involved systemic damage (286 cases, 19.13%), followed by hepatobiliary system damage (203 cases, 13.58%) and the skin and its appendages damage (186 cases, 12.44%). Abnormal liver function (162 cases, 10.84%) ranked the first place in appearance of serious ADR/ADE, followed by allergic shock (137 cases, 9.16%) and thrombocytopenia (97 cases, 6.49%). Conclusion:Anti-infective drugs associated serious ADR/ADE involved various categories and multiple systems and organs. Besides the efifcacy of anti-infection, we should focus on the function of liver, kidney and hematological system so as to handle safety issues in time.