| 摘要: |
| 目的:回顾性分析2014 年1 月至2024 年6 月贺州市医疗机构上报的18 岁以下儿童药品不良反应(ADR) 报告,探讨儿
童ADR 的发生情况、特点及主要诱因,为儿童ADR 监测与合理用药提供参考。方法:采用回顾性分析方法,对收集的ADR 报
告进行统计分析,包括ADR 类型、临床表现、发生时间、涉及药物种类、给药途径、患儿年龄及性别分布等。结果:收集的3 531 例ADR
报告中已知一般ADR 2 586 例(73. 23%),新的一般ADR 688 例(19. 48%),已知严重ADR 217 例(6. 15%),新的严重ADR 40 例
(1. 13%)。发生ADR 的患儿年龄主要为≥28 d ~ 7 岁。发生ADR 给药途径以静脉用药为主, 其中静脉滴注2 973 例
(84. 20%)、静脉注射95 例(2. 69%)、泵内注射29 例(0. 82%),其次是口服给药258 例(7. 31%)。引发ADR 的前3 位药品种类
分别为抗菌药物1 518 例(42. 99%)、中成药845 例(23. 93%)、抗病毒药物346 例(9. 80%)。ADR 最高的前10 种药品分别为注
射用双黄连冻干粉、清开灵注射液、注射用头孢曲松钠、注射用炎琥宁、注射用头孢哌酮钠/ 舒巴坦钠、注射用头孢呋辛钠、注射
用头孢他啶、注射用哌拉西林钠/ 舒巴坦钠、注射用阿奇霉素、痰热清注射液。ADR 累及系统/ 器官最多的是皮肤及其附件损害
(2 453 例,69. 47%),其次是消化系统损害(361 例,10. 22%) 和全身性损害(193 例,5. 47%)。结论:贺州市医疗机构上报的
ADR 发生情况、特点与国内报道相似,应强化医务工作者在静脉给药、联合用药、抗菌药物及中药注射剂的监管,加强专科临床
药师对ADR 的监测,减少儿童ADR 的发生,保障儿童用药安全。 |
| 关键词: 儿童 药品不良反应 用药安全 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.04.005 |
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| 基金项目: |
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| Investigation and Analysis on Adverse Drug Reactions in Children in Medical Institutions of Hezhou from2014 to 2024 |
| Yu Lihua1, Lai Jinglun2, Cai Lingyun2 |
| ((1. Hezhou Hospital of Traditional Chinese Medicine, Guangxi Hezhou 542899, China;
2. Hezhou Market Supervision and Administration Bureau, Guangxi Hezhou 542899, China)) |
| Abstract: |
| Objective: To retrospectively analyze the adverse drug reactions (ADR) reports of children under 18 years reported by
medical institutions in Hezhou from Jan. 2014 to Jun. 2024, and to explore the occurrence, characteristics and main causes of ADR in
children, so as to provide reference for monitoring and rational drug use of ADR in children. Methods: Retrospective analysis was used
to statistically analyze the types of ADR reports, clinical manifestations, timing of occurrence, drug categories, administration routes,
and age and gender distributions of affected children. Results: Among the 3,531 ADR reports collected, 2,586 cases (73. 23%) were
general ADR, 688 cases were new general ADR (19. 48%), 217 cases were severe ADR (6. 15%) and 40 cases were new severe ADR
(1. 13%). The age of children with ADR mainly ranged from ⩾28 d to 7 years. The main administration routes of ADR were
intravenous infusion in 2,973 cases (84. 20%), intravenous injection in 95 cases (2. 69%), and intra-pump injection in 29 cases
(0. 82%), followed by oral administration in 258 cases (7. 31%). The top 3 drug categories of ADR were respectively antibacterial
drugs in 1,518 cases (42. 99%), Chinese patent medicine in 845 cases (23. 93%) and antiviral drugs in 346 cases (9. 80%). The top
10 drugs with the highest ADR were respectively Shuanghuanglian injection (lyophilized), Qingkailing injection, ceftriaxone sodium for
injection, potassium sodium dehydroandrographolide succinate for injection, cefoperazone sodium for injection, cefuroxime sodium for
injection, ceftazidime for injection, piperacillin sodium and sulbactam sodium for injection, azithromycin for injection, and Tanreqing
injection. The most common system/ organ involvements caused by ADR were damage of skin and its appendages (2,453 cases,
69. 47%), followed by the digestive system damage (361 cases, 10. 22%) and systemic damage (193 cases, 5. 47%). Conclusion:
The situation and characteristics of ADR in medical institutions in Hezhou are similar to those reported in China. The supervision of
medical staff in intravenous drug administration, drug combination, antibacterial drugs and traditional Chinese medicine injection should
be strengthened, and the monitoring of ADR by clinical pharmacists should be enhanced, so as to reduce the occurrence of ADR in
children and ensure the medication safety. |
| Key words: children adverse drug reactions medication safety |
