儿童常用新型抗癫痫发作药国内外说明书儿童用药信息分析

Analysis of the Information of Children's Commonly Used New Anti-Seizure Medications in Drug Instructions in China and Abroad

目的分析中国、美国、欧洲说明书中儿童常用新型抗癫痫发作药用药信息差异,为完善说明书中儿童用药信息提供参考。方法收集中国、美国、欧洲儿童常用新型抗癫痫发作药说明书,统计分析儿童用药信息标注情况。结果共收集127份药品说明书,适应证、用法用量、注意事项、儿童用药等项目儿童用药信息标注率差异不大;美国药品说明书临床试验标注率明显高于中国(OR=31.31,P<0.05),欧洲药品说明书不良反应、药动学标注率明显高于中国(OR=0.13,P<0.05;OR=0.17,P<0.05)。虽然国内外药品说明书儿童适应证标注率相仿,但美国、欧洲批准的儿童适用年龄较宽泛、批准的发作类型更多。辅料标注率方面,美国、欧洲药品说明书标示率100.00%,中国仅为57.58%。结论儿童常用新型抗癫痫发作药国外说明书儿童用药安全性数据标注率明显高于中国,中国药品说明书儿童适应证较国外无论发作形式还是适用年龄均有不足,辅料标注率中国明显低于国外,需进一步推进药品说明书儿童用药信息的完善。

OBJECTIVE To analyze the differences in pediatric medication information in the instructions for new anti-seizure medications commonly used in children between China,the United States,and Europe,this provides a reference for improving the pediatric medication information in the instructions.METHODS The drug instructions approved by drug supervision and administration departments in China,the United States and Europe were collected,and the information about children's medication in the drug instructions was statistically analyzed.RESULTS A total of 127 drug package inserts were collected.The labeling rate of pediatric medication information showed little difference in indications,dosage and administration,precautions,and pediatric medication use;clinical trials in the United States were significantly higher than those in China(OR=31.31,P<0.05),and adverse reactions and pharmacokinetics in European drug package inserts were significantly higher than those in China(OR=0.13,P<0.05;OR=0.17,P<0.05).Although the labeling rate of indications for children in drug instructions was similar both domestically and internationally,the age range for children approved for use and the types of seizures approved were more extensive in the United States and Europe.The labeling rate of excipients in drug package inserts was 100.00%in the United States and Europe,and 57.58%in China.CONCLUSION The labeling rate of pediatric medication safety data in the instructions for new anti-seizure medications commonly used in children is significantly higher abroad than in China.The pediatric indications in China’s drug instructions are insufficient compared to foreign countries in terms of both seizure forms and applicable age ranges.The labeling rate of excipients in China is significantly lower than that in foreign countries,and there is a need to further promote the improvement of pediatric medication information in drug instructions.