基于药品综合评价的含朱砂类中成药说明书安全性内容分析  

Content Analysis of Safety Information in the Label of Chinese Patent Medicines Containing Cinnabar Based on Comprehensive Drug Evaluation

作　　者：郭红叶[1] 张爽 苑鹏程 金锐 杨毅恒[2] GUO Hongye;ZHANG Shuang;YUAN Pengcheng;JIN Rui;YANG Yiheng(Department of Pharmacy,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]中国中医科学院西苑医院药学部,北京100091 [2]北京大学第三医院药学部,北京100191

出　　处：《医药导报》2025年第5期732-737,共6页Herald of Medicine

基　　金：首都卫生发展科研专项(首发2020-2-2081);北京市中医药管理局第三批中药骨干人才培养项目(京中医科字〔2022〕59号)。

摘　　要：目的通过对含朱砂类中成药进行安全性评价,寻找评分高、评价等级好的中成药,从而为优化说明书安全性内容提出建议。方法对2020年版《中华人民共和国药典》中符合筛选标准的含朱砂的中成药建立数据库,分别从安全性和中成药毒性特点2个维度对该类中成药进行定量评分,同时对安全性证据进行分级评价。结果从安全性评价维度来看,具有相对较高安全性评分的中成药(评分≥5分)与该类药物说明书中明确报告药品不良反应的内容具有一定的相关性,并且该类中成药中54.55%证据风险可控,安全性较好。从中成药毒性特点评价维度看,组方配伍中毒性成分种类、用药日极量的评分对临床用药注意事项具有一定指导意义。结论含朱砂类中成药说明书中完善不良反应信息、对特殊人群用药限制情况进行提示,不仅对药物安全性评价分级具有重要的影响,而且为临床及患者安全用药能提供一定的警戒和参考。Objective Through the safety evaluation of Chinese patent medicines containing cinnabar,the correlation between the evaluation score and the content of drug instructions was analyzed.And the methods and suggestions for improving the label quality of Chinese patent medicines were proposed.Methods Establish a database of Chinese patent medicines and simple preparations containing cinnabar that meet the screening criteria in the 2020 edition of the Chinese Pharmacopoeia,and quantitatively score such Chinese patent medicines and simple preparations from the two first level dimensions of safety and toxicity characteristics of Chinese patent medicines and simple preparations,and at the same time,grade the level of safety evidence.Results From the perspective of safety evaluation dimension,Chinese patent medicines and simple preparations with relatively high safety score(safety score≥5 points)has a certain correlation with the content of adverse drug reactions clearly reported in the instructions of this kind of medicine,and 54.55%of the evidence risk of this kind of Chinese patent medicines and simple preparations is controllable,with good safety.From the perspective of the evaluation dimension of toxicity characteristics of Chinese patent medicines and simple preparations,the types of toxic ingredients in the compatibility of prescriptions and the scores of daily maximum dosage have certain guiding significance for clinical medication precautions.Conclusion For improving the adverse reaction information in the instructions of Chinese patent medicines and simple preparations containing cinnabar,and reminding the special population of drug use restrictions,it not only has an important impact on drug safety evaluation and grading,but also provides warning and reference for clinical and patient safety in drug use.

关 键 词：朱砂 中成药 说明书 药品综合评价 安全性评价 

分 类 号：R286[医药卫生—中药学] R288[医药卫生—中医学]