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| 国内8家儿童医院常用药品说明书中儿童用药信息的调查分析 |
| Investigation and Analysis of Children Medication Information of Pediatric Commonly-used Drug Instructions in 8 Children’s Hospitals |
| 投稿时间：2020-05-01 修订日期：2020-12-24 |
| DOI： |
| 中文关键词: 药品说明书 儿童用药 调查分析 |
| 英文关键词: Drug instruction Pediatric medication Investigation and analysis |
| 基金项目:国家科技重大专项 |
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| 中文摘要: |
| 目的：了解我国儿科常用药品说明书中的儿童用药信息标注情况，为儿童合理用药提供参考。方法：以我国8家三甲儿童医院常用化学与生物制品作为研究对象，对说明书中的儿童用药信息进行统计分析。结果：在儿科常用药品的2083个品规中，注射剂有1063种（占51.03%），外用剂型155种（占7.44%），雾化吸入剂型57种（占2.73%），口服剂型808种（占38.79%）。儿童专用药品品规数有74个（占3.55%）。儿科常用药品中标注了儿童用法用量的有1126个（占54.06%）、儿童最大剂量190个（占9.12%）、儿童用药疗程90个（占4.32%），儿童注意事项537个（占25.78%），儿童禁忌118个（占5.66%），儿童不良反应190个（占9.12%）。结论：目前我国儿童专用药品少，儿科常用药品说明书中儿童用药信息缺乏，且存在同一药品说明书差异大、说明书内容表述不规范等问题。建议相关部门加强对药品说明书内容的审核力度，督促药品生产企业完善说明书中儿童用药信息，加强对药品说明书的规范和管理，保证说明书各项目的完整性及内容的准确性，促进药物的合理使用。 |
| 英文摘要: |
| Objective：To investigate the children medication information of instructions in pediatric commonly used medicines in our country and provide reference for safe medication in children. Methods：The children medication information in the pediatric commonly used chemicals and biologicals instructions of eight 3A children's hospitals were collected and statistically analyzed. Results：The 2083 kinds of pediatric commonly used medicines were collected, including 1063 kinds of injections (51.03%), 155 kinds of external preparations (7.44%), 57 kinds of atomization inhalation formulations (2.73%) and 808 kinds of oral dosage forms (38.79%). Only 74 kinds of medicines belonged to child-specific medicines among the pediatric commonly used medicines. The items of children’s usage and dosage were 1126 (54.06%), children’s maximum dosage were 190 (9.12%), children’s treatment course were 90 (4.32%), children’s attention were 537（25.78%）, children’s contraindications were 118 (5.66%), children’s adverse reactions were 190 (9.12%). Conclusions：The child-specific medicines is insufficient in our country. The information on children medication in the instructions of pediatric commonly used medicines is deficient，and there are some problems such as differences and nonstandard statement in instructions. It is suggested that the relevant departments should strengthen the audit of drug instructions content, urge the improvement of instructions about children medication information in pharmaceutical production enterprise, strengthen the standard and management of drug instructions, guarantee the integrality of items ,the accuracy of the content, and promote the rational use of drugs. |
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