| 摘要: |
| 目的:分析儿童中药注射剂不良反应(ADR)发生情况,为临床合理用药提供参考。方法:从国家药品ADR 监测系统中
收集2006-2021 年中成药不良反应案例1 356 例,筛选出中药注射剂在儿童中发生的ADR 共104 例。从患儿因素、药物因素及
临床因素3 个角度对ADR 的特点及原因进行分析。结果:男65 例(62. 50%),女39 例(37. 50%);≤5 岁59 例(56. 73%);复方
制剂63 例(60. 58%),单一组分制剂41 例(39. 42%);用药后30 min 内发生ADR 86 例(82. 69%)。结论:儿童尚处于生长发育
阶段,需要重视中药注射剂在儿童中的应用,谨慎用药,加强监测,以减少或避免ADR 的发生。 |
| 关键词: 儿童 中成药 中药注射剂 不良反应 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.01.006 |
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| 基金项目: |
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| Analysis of Adverse Drug Reactions Induced by Traditional Chinese Medicine Injections in 104 Children |
| Xu Jian, Tang Zhihua |
| ((Shaoxing People’s Hospital, Zhejiang Shaoxing 312000, China)) |
| Abstract: |
| Objective: To analyze the occurrence of adverse drug reactions (ADR) induced by traditional Chinese medicine injections
in children, so as to provide reference for rational drug use in clinic. Methods: A total of 1,356 cases of ADR induced by Chinese
patent medicines were collected from the National ADR Monitoring System from 2006 and 2021. Totally 104 cases of ADR induced by
traditional Chinese medicine injections in the pediatric population were selected for analysis. The characteristics and causes of ADR were
analyzed from three perspectives: patient factors, drug factors and clinical factors. Results: Of the 104 cases, 65 cases (62. 50%) were
males and 39 cases (37. 50%) were females. In the age group of ⩽5 years, there were 59 cases (56. 73%). Composite formulations
accounted for 63 cases (60. 58%), while single-component formulations accounted for 41 cases (39. 42%). ADR occurred within
30 minutes after administration in 86 cases (82. 69%). Conclusion: As children are still in the stage of growth and development,
attention should be paid to the use of traditional Chinese medicine injections. Prudent drug use, enhanced monitoring, and measures to
reduce or avoid ADR are recommended. |
| Key words: children Chinese patent medicines traditional Chinese medicine injections adverse drug reactions |
