中成药药品说明书中禁忌注意事项不良反应的调查分析

Investigation and analysis of contraindication,note and untoward reaction in traditional Chinese patent medicine instructions

目的调查分析258份中成药说明书中禁忌、注意事项、不良反应及存在的问题,为完善药品说明书提供科学依据。方法收集洛阳市第三人民医院药房中成药说明书258份,根据国家食品药品监督管理局2006年颁布的《药品说明书和标签管理规定》及其他参考资料对不同剂型的中成药说明书中禁忌、注意事项不良反应、各项欠缺情况进行统计并考察其文字表述的规范性。结果在所调查的258份中成药说明书中,不良反应、禁忌、注意事项明确叙述的标注率分别为34.88%、46.51%、78.29%;2个剂型的说明书都有不同程度的表述欠完整、规范。结论中成药说明书仍需要不断完善,其表述的不完整现象应引起重视并加强监管。

Objective To analyze 258 Chinese patent medicines instructions contraindications precautions adverse reac-tions, and the problems, provide a scientific basis for improving the package insert. Methods Colleetied the 258 pro-prietary Chinese medicine instructions from the No. 3 People＇ s Hospital of Luoyang City pharmacies, promulgated in 2006 by the State Provisions for Drug Insert Sheets and Labels regulations, and other reference materials of different for- mulations statistics precautions adverse reactions and the situation of lack tion and examine its textual representation normative. Results Surveyed 258 Chinese patent medicines instructions, clear narratition of the label rate of adverse re- actions, contraindications, precautions were 34. 88% , 46. 51% , 78.29%, the two formulations of the instructions have different levels of representation incomplete specification. Conclusions Instaructions of traditionaal Chinese medicines still need to constantly improve instructions, incomplete statements, attention should be paid and strengthen supervision.