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四川省2012~2014年儿童药品不良反应分析

Adverse Drug Reactions in Sichuan Children During 2012-2014

  • 摘要: 目的 对四川省2012~2014年儿童药品不良反应的发生情况进行描述、分析,促进儿科合理用药,为儿科药物遴选提供基础。 方法 数据选取2012~2014年四川省药品不良反应/事件监测数据库中0~18岁患者信息,对其3年变化趋势、人口学特征、用药信息、不良反应表现〔按器官系统分类(system organ class, SOC)〕及其转归进行描述及分析。 结果 2012~2014年四川省儿童药品不良反应发生数量呈上升趋势。性别构成上男性(7 709例,56.40%)多于女性(5 932例,43.40%);年龄构成上学龄前儿童发生数量最多(5 928例,43.37%)。最常见给药途径为静脉滴注(8 492例,62.13%),最常见表现为皮肤系统及其附件损害(7 510例,55.10%)。严重不良反应267例,发生率为1.95%,其中最多表现为全身性损害(120例,44.94%)。多数不良反应程度较轻,结局以痊愈、好转为主(13 515例,98.87%),但亦有死亡病例(5例,0.04%)。 结论 儿童药品不良反应多出现于5岁以下儿童、静脉滴注给药,严重不良反应表现与一般不良反应有差异,需引起医务人员重视。

     

    Abstract: Objective To determine the characteristics of adverse drug reactions (ADRs) in children. Methods Reported ADRs in the patients aged from 0-18 years were extracted from the 2012-2014 Sichuan ADR surveillance system. The time trend, category of ADRs 〔system organ class (SOC)〕, outcomes, and demographic characteristics of the patients were analyzed. Results The reported paediatric ADRs increased over time; most occurred in males (7 709, 56.40%) and preschool children (5 928, 43.37%). The majorities involved intravenous drips (8 492, 62.13%) and skin and appendages (7 510, 55.10%). About 267 (1.95%) cases were deemed as serious ADRs, most (120, 44.94%) involving whole body consequences. The majority (13 515, 98.87%) of patients recovered. But deaths (5, 0.04%) were also reported. Conclusion Pediatric ADRs are associated with young age (less than 5 years old) and intravenous drips. Serious ADRs should be identified for early interventions.

     

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