| 摘要: |
| 目的：调查注射剂药品说明书中关于儿童用药安全信息的标注情况，分析儿童用药风险。方法：统计我院141份常用注射剂说明书，分析儿童用药安全信息标注情况。结果：儿童专用药品说明书4份，占2.8%。国产药和外资药儿童临床试验数据和儿童药代动力学的数据标注率分别为4.7%、40.0%和11.3%、34.3%，儿童用法用量标注率分别为51.9%、68.6%，外资药高于国产药；抗感染类药物说明书儿童临床试验项、儿童药代动力学项标注率分别为29.4%、37.3%，明显高于其他类别。限制级抗菌药物的儿童临床试验项、儿童药代动力学项标注率分别为77.8%、77.8%，明显高于其他类别。外资西药和国产西药的儿童临床试验项、儿童药代动力学项标注率分别为40.0%、34.3%和4.9%、11.8%，西药高于中成药。儿童专用药品未出现儿童用药安全信息的标注缺失情况；非儿童专用药品的儿童用法用量项、儿童药代动力学项标注率分别为54.7%和17.5%，非儿童专用药品标注率低于儿童专用药品。部分国产西药与外资西药说明书儿童用药项存在差异。结论：注射剂中儿童专用药品较少，非儿童专用药品中儿童用药安全信息标注不充分，儿童用药存在风险隐患 |
| 关键词: 注射剂 药品说明书 儿童 信息 风险 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2020.07.013 |
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| 基金项目: |
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| Medication Information Annotations in Pediatric Injection Instructions and Risk Analysis of Children’s Medication |
| Tao Baicheng, Xue Jin, Zhou Lifang |
| (Children’s Hospital of Soochow University, Jiangsu Suzhou 215025, China) |
| Abstract: |
| Objective: To investigate the medication information annotations in pediatric injection instructions, and to analyze the risks of children’s medication. Methods: Through the statistics of 141 commonly used injection instructions in our hospital, the medication information annotations in pediatric injection instructions were analyzed. Results: Totally 4 pieces of instructions for child-specific medicines, accounting for 2.8%. The annotation rates of children’s clinical trials and pharmacokinetics for domestic and foreign medicines were respectively 4.7%, 40.0% and 11.3%, 34.3%, and the usage and dosage rates for children were respectively 51.9% and 68.6%, the data of foreign medicines were higher than those of domestic medicines. The annotation rates of children’s clinical trials and pharmacokinetics for anti infective drugs were respectively 29.4% and 37.3%, significantly higher than those in other categories. The annotation rates of children’s clinical trials and pharmacokinetics for restricted grade antibiotics was 77.8% and 77.8%, significantly higher than those in other categories. The annotation rates of children’s clinical trials and pharmacokinetics for foreign western medicine and domestic western medicine were respectively 40%, 34.3% and 4.9%, 11.8%, and the data of western medicine were higher than those of the traditional Chinese patent medicine. There was no lack of annotation of children’s medication safety information for child-specific medicines. The annotation rates of usage and dosage items and pharmacokinetics for non-child-specific medicines were respectively 54.7% and 17.5%, and the annotation rates for non-child-specific medicines were lower than those for child-specific medicines. There were differences in the children’s medicines in the instructions for some domestic and foreign medicines. Conclusion: There are few child-specific medicines in injections and inadequate annotations of safety information for children’s medication in non-child-specific medicines, and there are potential risks for children’s medication |
| Key words: injection instructions children information risks |
