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34家儿童医疗机构镇咳祛痰药品说明书信息标注情况分析 Δ

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丁 臻 ，梁 海 ，阮文懿 ，蔡和平 （1.安徽省儿童医院临床药学部，合肥 230022；2.亳州市人民医院药学
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部，安徽 亳州 236800）
中图分类号 R974+.1；R985 文献标志码 A 文章编号 1001-0408（2024）05-0607-05
DOI 10.6039/j.issn.1001-0408.2024.05.17

摘 要 目的 了解儿童医疗机构常用镇咳祛痰药药品说明书中儿童用药信息标注情况，并提出相关建议。方法 收集我国具有
区域代表性的20家三级儿童医院（中心）和14家妇幼保健院（中心）的100种常用镇咳祛痰药的说明书，对药品说明书中儿童用药
信息标注情况进行调查分析。结果 专用儿童镇咳祛痰药只有7种，其他均为非儿童专用药；镇咳祛痰药中片剂占18.00％，注射
剂占18.00%，胶囊剂占4.00％；100种镇咳祛痰药中72种（占72.00％）标注了儿童用法用量，63种（占63.00％）标注了儿童用药项，
59种（占59.00％）注意事项中注明了儿童信息，均未标注儿童药动学参数；对比进口或合资的镇咳祛痰药，国产药品儿童用药信息
标注缺失较多；63种标注有儿童用药项的药品说明书中，多种说明书标注信息指导意义不大。结论 镇咳祛痰药说明书中儿童用
药信息存在标注缺乏的情况，儿童专用药品占比低，说明书中儿童用药项标注信息对儿童用药指导意义不大。相关部门应进一步
推进镇咳祛痰药的药品说明书中儿童用药信息的完善，保障儿童用药的合理使用。
关键词 镇咳祛痰药；儿童；药品说明书；用药信息标注；调查

Analysis of information labeling in instructions of antitussive and expectorant drugs in 34 children’s
medical institutions
DING Zhen ，LIANG Hai ，RUAN Wenyi ，CAI Heping（1. Dept. of Clinical Pharmacy， Anhui Provincial Children’s
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Hospital， Hefei 230022， China；2. Dept. of Pharmacy， Bozhou People’s Hospital， Anhui Bozhou 236800，
China）
ABSTRACT OBJECTIVE To understand the information labeling of children’s medication in the instructions of antitussive and
expectorant drugs commonly used in children’s medical institutions， analyze the existing problems， and propose relevant
suggestions. METHODS The instructions for 100 antitussive and expectorant drugs commonly used in 20 tertiary children’s
hospitals （centers） and 14 maternal and child health hospitals （centers） with regional representativeness in China were collected，
and the information labeling of children’s medication in the instructions was investigated and analyzed. RESULTS There were only
7 kinds of antitussive and expectorant drugs for children， and the others were non-specific drugs for children. Among antitussive
and expectorant drugs， tablets accounted for 18.00%， injections for 18.00%， and capsules for 4.00%. Among 100 antitussive and
expectorant drugs， 72 （72.00%） labeled the usage and dosage for children， 63 （63.00%） labeled the medication items for children，
59 （59.00%） indicated the information of children in the precautions， and pharmacokinetic parameters for children were absent.
Compared with imported antitussive and expectorant drugs or the drugs manufactured by joint ventures， there were many missing
labeling of medication information for children with Chinese drugs. Among 63 kinds of drug instructions labeled with medication
items for children， various instructions information had little guiding significance. CONCLUSIONS There is a lack of labeling in
the instructions of antitussive and expectorant drugs for children， and the proportion of special drugs for children remains low.
Pediatric drug information in the instructions has little guiding significance for pediatric medication. Relevant departments should
further promote the completeness of pediatric medication information in the instructions of antitussive and expectorant drugs to
ensure the rational use of children’s medication.
KEYWORDS antitussive and expectorant drugs； children； instruction； medication information labeling； investigation

Δ 基金项目 安徽省重点研究与开发计划项目（No.2022e07020066） 咳嗽咳痰是儿童呼吸系统疾病常见的症状，通常由
＊第一作者 副主任药师，硕士。研究方向：医院药学。电话：
上呼吸道感染引起，其他疾病、过敏原或运动引发的支
0551-62237352。E-mail：25399089@qq.com
气管痉挛也会引起咳嗽。作为一种保护性反射，咳嗽促
# 通信作者 主任药师，硕士。研究方向：临床药学、药事管理。电
话：0551-62237131。E-mail：greenhprui@163.com 进了黏液纤毛运动，有助于清除气道中过多的分泌物和

中国药房 2024年第35卷第5期 China Pharmacy 2024 Vol. 35 No. 5 · 607 ·