Analysis on 5099 ADR reports occurred in children in military hospitals from 2009 to 2014

XIE Ting-ting; GUO Dai-hong; ZHAO Su-yu; MA Liang; ZHAO Liang; XU Yuan-jie; ZHU Man; ZHAO Peng-zhi; GUO Jun-rong

Abstract：Objective:To investigate the characteristics and general pattern of adverse drug reaction (ADR) occurred in children, and provide reference for clinical rational drug use.Methods:With the retrospective method, a total of 5099 ADR reports occurred in children were collected from 2009 to 2014 in the database of PLA ADR monitoring center. The data in respect of age and gender of patients, categories of drugs, route of administration, dosage form, systems and organs involved in ADR and clinical manifestations, relevance evaluation and prognosis were analyzed statistically.Results:Among 5099 ADR reports, new and severe ADR reports were 261 cases (5.11%), the male to female ratio was 1.56 : 1, the average age of the patients was (5.12 ± 2.55) years, the incidence of ADR was the highest in the childeren of 1 – 3 years old (28.85%). Intravenous infusion and injection type were the main administration route and dosage form, respectively. The ADRs were related to 16 kinds of drug categories. The top 3 drug categories involved in ADRs were anti-infection drugs (54.17%), Chinese patent medicine (8.16%), electrolyte and acid-base balance and nutrition drugs (7.79%), respectively. These children's ADRs involved multiple systems and organs (7046 frequencies), the most common clinical manifestation was skin and its accessories damage (3458 frequencies, 49.08%), followed by gastrointestinal system damage (1547 frequencies, 21.96%) and systemic damage (595 frequencies, 8.44%).Conclusion:We should strengthen the risk prevention work on children's drugs and the rational use of drugs in pediatrics. ADR monitoring and drug consulting work need to be paid more attention to, in order to reduce or avoid the occurrence of ADR.