中国多地区儿童医院β内酰胺类抗菌药物说明书中相关儿童用药信息研究

Study on Medication Information in Drug Instructions of β-lactam Antibiotics in Children's Hospitals in Multiple Regions of China

关键词:  β内酰胺类抗菌药物  儿童  药品说明书  用药信息

Key words:  β-lactam antibiotics  child  drug instructions  medication information

摘要:

目的 调查全国多地区儿童医院常用β内酰胺类抗菌药物说明书中相关儿童用药信息的标注情况，为进一步完善β内酰胺类抗菌药物说明书中儿童用药信息提供参考依据。方法 收集国内20所儿童医院847份β内酰胺类抗菌药物说明书，对药品说明书中相关儿童用药信息标注情况进行统计分析。结果 排除重复后共396份抗菌药物说明书，涉及62个品种，其中包含青霉素类12个(59份)，头孢菌素类27个(201份)等；但儿童专用抗菌药物仅2种，儿童和成人共用药最多有376份；注射剂最多有284份(71.72%)，口服制剂112份(28.28%)，其中儿童较适宜的剂型有干混悬剂(24.11%)、颗粒剂(23.21%)、咀嚼片(4.46%)。396份说明书中明确儿童适应证、儿童用法用量、儿童用药项、儿童药动学、不良反应的标注率分别为27.78%，93.69%，64.65%，39.14%，20.96%，口服剂型中儿童适应证标注率32.14%，儿童用法用量标注率95.53%，儿童用药项标注率58.93%，其中注意事项和不良反应标注与注射剂有显著差异(P<0.05)；国产药较涉外药儿童用药信息标注情况相差不大，但注意事项信息标注差异有统计学意义(P<0.05)；7大区域儿童医院间儿童用药信息标注率差异无统计学意义。结论 β内酰胺类抗菌药物儿童专用品种少，其说明书中相关儿童用药信息标注不完善，说明书信息指导意义不足，相关部门应给予重视，完善说明书中儿童用药信息，保障儿童安全合理用药。

Abstract:

OBJECTIVE To investigate the children's medication information in β-lactam antibiotics's in children's hospitals in multiple regions, and to provide reference for further improving the drug information in the instructions of β lactam antibiotics. METHODS Collecting 847 drug instructions of β-lactam antibiotics in twenty children's hospitals in China, medication information labeling in drug instructions on children was investigated and analyzed. RESULTS After excluding duplicates, a total of 396 antibacterial drug inserts were obtained, involving 62 varieties, including 12 penicillins(59 copies), 27 cephalosporins(201 copies), etc. But there was two antibacterial drug for children only and up to 376 drugs for children and adults. In all drugs, there were 284 injections(71.72%) and 112 oral preparations(28.28%), among which the most suitable dosage forms for children were dry suspension(24.11%), granules(23.21%) and chewable tablets(4.46%). The annotation rates of children's indication, children's usage and dosage, children's drug guidance, pharmacokinetics in children, children's adverse reactions(396 categories) were respectively 27.78%, 93.69%, 64.65%, 39.14%, 20.96%, respectively. In oral dosage forms, the labeling rate of children's indications was 32.14%, the labeling rate of children's usage and dosage was 95.53%, the labeling rate of medication items for children was 58.93%, among them there were significant differences in the precautions and adverse reaction labeling rates between oral preparation and injections(P<0.05). There was not much difference in the labeling of pediatric medication information between domestic drugs and foreign-related drugs, but there was significant difference in the information labeling of precautions(P<0.05). There was no significant difference in the labeling rate of children's medication information among the seven regional children's hospitals. CONCLUSION There are few pediatric-specific β-lactam antibiotics, and the labeling information for pediatric use in their respective instructions is often incomplete and insufficient to provide meaningful guidance. Relevant departments should pay attention to the incomplete mark of drug use for children, improve the medication information of children in the instructions, and ensure the safety of pediatric drug use.