| 摘要: |
| 目的:基于日本药物不良事件报告(JADER)数据库对儿童使用新型四环素类药物(多西环素和米诺环素)有关药物不良 事件(ADE)信号进行检测,为新型四环素类药物在儿童中的安全使用提供参考。 方法:采用报告比值比(ROR)法和综合标准 (MHRA)法,对 JADER 数据库中患者年龄<10 岁或年龄层为“新生儿”“婴幼儿”或“儿童”的,以新型四环素类药物为怀疑药物 的相关 ADE 报告进行数据挖掘。 结果:共检索到目标 ADE 报告 69 例。 其中,多西环素 2 例,米诺环素 67 例。 由于检索到的多 西环素相关 ADE 较少,未检测到 ADE 风险信号。 检测到米诺环素相关 ADE 风险信号 8 个,涉及 6 个器官分类(SOC)。 其中, 多形性红斑等 6 个 ADE 风险信号为药品说明书收载的已知 ADE,闭塞性细支气管炎和谵妄 2 个 ADE 风险信号未在药品说明 书中记载。 未发现牙齿变色和牙齿发育不良相关 ADE 风险信号。 结论:本研究得出的相关安全性信息为新型四环素类药物的 儿童临床应用提供了有益参考。 |
| 关键词: 新型四环素类 药物不良事件 闭塞性细支气管炎 谵妄 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2025.09.012 |
|
| 基金项目:许昌市重点研发与推广专项(科技攻关、软科学研究)备案项目,编号 20230213065。 |
|
| Pharmacovigilance Study of Novel Tetracyclines in Children Based on Japanese Adverse Drug Event Report Database |
| Cao Kai, Qian Peipei, Zhang Xiaohan, Zhao Liang |
| (Xuchang Central Hospital Affiliated to Henan University of Science and Technology, Henan Xuchang 461000, China) |
| Abstract: |
| ]Objective: To detect the adverse drug event ( ADE) risk signals associated with novel tetracyclines ( doxycycline and minocycline) in children based on Japanese Adverse Drug Event Report (JADER) database, so as to provide reference for the safe use of novel tetracyclines in children. Methods: Reporting odds ratio (ROR) method and medicines and healthcare products regulatory agency (MHRA) method were used for data mining on the ADR reports related to novel tetracyclines as “suspect” drugs in patients “< 10 years old” or in the age group of “newborn” “infant” or “child” in JADER database. Results: A total of 69 target ADE reports were retrieved. Among them, 2 cases were doxycycline and 67 cases were minocycline. Due to the limited number of ADE cases, no ADE risk signals related to doxycycline were detected. Eight ADE risk signals corresponding to 6 system organs class ( SOC) related to minocycline were detected. Among them, 6 ADE risk signals, including erythema multiforme, were known ADE listed in the drug instructions, while the two ADE risk signals of obliterative bronchiolitis and delirium were not recorded in the drug instructions. No ADE risk signals related to tooth discolouration or tooth hypoplasia were detected. Conclusion: The relevant safety information obtained from this study provides valuable reference for the clinical application of novel tetracyclines in children. |
| Key words: novel tetracyclines adverse drug events bronchiolitis obliterans delirium |
