| 摘要: |
| 目的:挖掘分析儿童药品不良反应(ADR)的发生情况、规律及特点,为儿童安全用药提供参考。方法:调取2020 年通过
自发呈报系统上报至山东省ADR 监测中心的11 904 例儿童ADR 数据,对报告类型、来源、报告人职业和患者性别、年龄、ADR
转归及关联性评价、合并用药、怀疑药品类别、累及器官/ 系统进行统计分析。结果:11 904 例儿童ADR 报告中,一般ADR 9 732
例(81. 75%),严重ADR 1 143 例(9. 60%),新的ADR 1 029 例(8. 64%);报告主要来源于医疗机构(99. 70%);报告人主要为医
师(47. 60%);患儿年龄3~7 岁居多(26. 89%),转归以痊愈和好转为主(99. 11%);关联性评价主要为“很可能” (78. 56%);合
并用药占比22. 88%;主要给药途径为静脉给药(71. 72%);怀疑药品类别分布前5 位依次为抗感染药物(59. 32%)、中药制剂
(10. 63%)、呼吸系统用药(7. 69%)、调节水电解质酸碱平衡用药(5. 58%) 以及中枢神经系统用药(2. 82%),分别涉及94、188、
40、81 和101 个品种;累及器官/ 系统主要为皮肤及其附件(47. 98%)。结论:建议规范儿童用药,关注儿童ADR 发生的规律特
点,加强儿童用药ADR 监测,保障儿童用药安全、合理。 |
| 关键词: 儿童用药 不良反应 报告分析 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2023.04.007 |
|
| 基金项目:中国毒理学会临床毒理专项课题,编号CST2019CT307;山东省药品不良反应监测哨点研究课题,药械化-2020-SDADRKY04;潍坊
市卫生健康委员会中医药科研项目,编号2022-4-023。 |
|
| Analysis of Adverse Drug Reactions in Children of Shandong Province in 2020 Based on Real-WorldMonitoring Data |
| Chen Huanlei, Li Xiaoyao, Wang Guanjie, Li Ning, Wang Zhenhua |
| ((Weifang Hospital of Traditional Chinese Medicine,
Shandong Weifang 261041, China)) |
| Abstract: |
| Objective: To discover and analyze the adverse drug reactions (ADR) in children and its regularity, to provide references for
the safe medication of children. Methods: The 11,904 children’s ADR data reported to ADR Monitoring Center through the spontaneous
reporting system in the year of 2020 were retrieved, and statistical analysis was performed on the report type, source, reporter’s occupation
and patient’s gender, age, ADR outcome and relevance evaluation, combined drugs, suspected drug categories, and involved organs/
systems. Results: Among the 11,904 cases of children’s ADR reports, general ADR accounted for 81. 75% (9,732 cases), serious ADR
accounted for 9. 60% (1,143 cases), and new ADR accounted for 8. 64% (1,029 cases). The reports were mainly from medical
institutions (99. 70%), and the majority of reporters were physicians (47. 60%). Most of children were mainly 3 to 7 years old
(26. 89%). The main outcomes were recovery and improvement (99. 11%), and the relevance evaluation was mainly “probable”
(78. 56%). Drug combination accounted for 22. 88%, and the intravenous drip (71. 72%) was the main route of administration. The top
five drugs suspected were anti-infection-related drugs (59. 32%), traditional Chinese medicine preparations (10. 63%), respiratory system
drugs (7. 69%), water, electrolyte and acid-base balance regulating drugs (5. 58%) and central nervous system drugs (2. 82%),
involving 94, 188, 40, 81 and 101 varieties, respectively. The organs/ systems involved were mainly skin and its accessories (47. 98%).
Conclusion: It is recommended to regulate children’s medication, pay attention to the regular characteristics of children’s ADR, and
strengthen the monitoring of children’s ADR of medication, in order to ensure the safety and rationality of children’s medication. |
| Key words: children’s medication adverse drug reaction report analysis |
