192种中成药说明书中特殊人群用药信息的调查分析  

Investigation and Analysis of Drug Information on Special Populations in 192 Package Inserts of Traditional Chinese Medicine

作　　者：王翔岩[1] 李英涛[2] 张翠莲[2] 

机构地区：[1]首都儿科研究所附属儿童医院,北京100730 [2]中国医学科学院北京协和医学院北京协和医院

出　　处：《中国药事》2011年第7期667-669,共3页Chinese Pharmaceutical Affairs

摘　　要：目的调研中成药说明书中特殊人群用药信息标注,以促进中成药说明书的规范,更好地为临床用药提供参考依据。方法按照2006年6月SFDA发布的《中药、天然药物处方药说明书撰写指导原则》,对本院在用的192种中成药说明书中特殊人群用药信息进行统计、分析。结果本院在用的187种非儿童专用中成药说明书中对儿童用药、老年用药和妊娠期妇女及哺乳期妇女用药进行了说明的分别为36.90%、25.67%和61.50%,未对三类特殊人群用药做任何说明的中成药说明书占34.76%。结论目前中成药说明书对特殊人群用药信息的标注存在信息量不足,过于简单和描述不准确等问题,应进一步完善其说明书管理。Objective To investigate and analyze the drug information on special populations in 192 package inserts of traditional Chinese medicine（TCM） so as to strengthen the standardization and regulation to the package inserts of TCM and provide a reference for clinical.Methods To analyze each items of information on special populations in 192 package inserts of TCM sampled in pharmacy of Peking Union Medical College Hospital in accordance with the guiding principle of package inserts for TCM and natural medicine announced by SFDA in 2006.Results Only one package inserts in the 187 non-child-specific drugs met the requirement of the guiding principle,drug use information for children,elderly and pregnant and lactating women respectively for 36.90%,25.67% and 61.50%,no drug use information for these three types of special populations for 34.76%.Conclusion Now there are some problems about package inserts of TCM,such as inadequate information and simple,inaccurate description.To ensure safe use,the package inserts of TCM should be further improved.

关 键 词：中成药说明书 儿童用药 老年患者用药 妊娠期及哺乳期妇女用药 

分 类 号：R288[医药卫生—中药学]