部分儿童适宜药品在五项权威资料中的适宜年龄段分析

目的：调研并分析部分儿童适宜药品在五项权威资料中的适宜年龄段,以期为我国儿童临床合理用药提供参考。方法：调研药品说明书、中国国家处方集（儿童版）（CNFc）、英国国家处方集（儿童卷）、WHO儿童标准处方集、WHO儿童基本药物标准清单（WHO EMLc）,将结果进行统计分析。结果：调研品种在五项权威资料中收录的比例差异较大,在CNFc中接近80%,而在WHO EMLc中,仅为49.3%;儿童用药剂量计算方法有"按年龄"、"按体质量"、"按体表面积"等6种,但均以"按年龄"为主;说明书和其他四项资料两两比较,适宜年龄段一致的品种最高仅为31%;五项参考资料适宜年龄段均一致的品种仅有14个,部分资料适宜年龄段一致的品种也仅有129个;全部或部分适宜年龄段一致的品种中,有51%的品种适用于新生儿。结论：五项参考资料收录的活性成分和品种、儿童用药剂量计算方法、品种的适宜年龄段等方面存在较大差异;对于适宜年龄段一致的品种,临床使用时可直接参考;对于适宜年龄段不一致的品种,建议将五项资料的优先级进行排序,笔者建议的顺序为：药品说明书、中国国家处方集（儿童卷）、WHO儿童标准处方集、WHO儿童基本药物标准清单、英国国家处方集（儿童卷）。

Analysis on suitable age group for certain medicine can be used by children in five authoritative references

OBJECTIVE To investigate and analyze the suitable age group of some appropriate drugs for children in five authoritative references,so as to provide reference for rational drug use for children in China.METHODS Related information in drug package inserts,Chinese National Formulary (Chemicals and Biological Products for Children)(CNFc),British National Formulary for Children (BNFc),WHO Model Formulary for Children,WHO Model List of Essential Medicines for Children (WHO EMLc) was collected and then the results were analyzed.RESULTS The proportion of the investigated formulations included in the five authoritative references varied greatly,with nearly 80% in CNFc and only 49.3% in WHO EMLc;the calculation methods of the dosage for children included "by age","by body mass" and "by body surface area",but all of them were mainly "by age" in all 5 references;the package insert was compared with the other authoritative references,and the highest number of formulations with the same age group was only 31%;there were only 14 formulations with the same age group in the five reference data,and only 129 formulations with the same age group in some data;among the formulations with the same age group in all or part,51% of the formulations were suitable for newborns.CONCLUSION Significant differences were found among the five references in terms of active ingredients and formulations,methods of children's dose calculation,suitable age group of formulations.The same suitable age group of the formulation provided by all or partial references can be used as a guide for desicion;However,for formulations with inconsistent information,it is recommended to rank the priority of the five references as follows:drug package inserts,Chinese National Formulary (Chemicals and Biological Products for Children),WHO Model Formulary for Children,WHO EMLc,and BNFc.