中药大品种口服中成药说明书安全性信息分析

doi:10.19803/j.1672-8629.2021.10.19

摘要/Abstract

摘要： 目的通过分析和总结中药大品种科技竞争力前100名的口服中成药说明书安全性信息的完整性、规范性和严谨性,为口服中成药的临床安全使用和开发应用提供参考。方法收集中药大品种口服中成药科技竞争力前100名的药品现行说明书95份,对涉及的安全性信息,包括成分、不良反应、禁忌、注意事项、特殊人群用药提示、药物相互作用、临床试验及药理毒理报告、警示语等项目的标注情况进行统计分析。结果纳入分析的口服中成药说明书中存在对有毒、药性峻猛药物、涉及十八反十九畏药物警示不足;说明书中不良反应、使用注意、禁忌信息存在尚不明确的信息;部分使用注意、药物相互作用、警示语存在的无效信息。结论应加强口服中成药说明书安全性信息规范化标注,为医师和患者合理用药提供依据。

关键词: 口服中成药, 说明书, 安全性信息, 中药大品种, 科技竞争力

Abstract: Objective To summarize and analyze the integrity, standardization and rigor of the safety information of oral Chinese patent medicines that are listed among the top 100 in the scientific and technological competitiveness of major varieties of big brand traditional Chinese medicine, and to provide reference for the clinical safe use and development and application of oral Chinese patent medicines. Methods 95 copies of the current drug instructions of oral Chinese patent medicines that are listed among the top 100 in the scientific and technological competitiveness of major varieties of big brand traditional Chinese medicine were collected, then the security information, including ingredients, adverse reactions, contraindications, cautions, medication tips for special populations, drug interactions, clinical trials and pharmacological toxicology reports, warnings were statistically analyzed, then the security information, including ingredients, adverse reactions, contraindications, cautions, medication tips for special populations, drug interactions, clinical trials and pharmacological toxicology reports, warnings were statistically analyzed. Results There exit some medicine instructions lack of warnings for toxic and powerful drugs and the eighteen incompatible medicaments &the nineteen medicaments of mutual restraint drugs. Adverse reactions, cautions, and contraindications were not clear. Invalid information exists in cautions, drug interactions, and warnings. Conclusion The safety information of oral Chinese patent medicine specifications should be standardized, so as to provide basis for rational drug use by doctors and patients.

Key words: oral Chinese patent medicine, medicine instructions, safety information, big brand traditional Chinese medicine, scientific and technological competitiveness

中图分类号:

R994.11

周莎, 杨洪军, 荆志伟, 李耿. 中药大品种口服中成药说明书安全性信息分析[J]. 中国药物警戒, 2021, 18(10): 981-985.

ZHOU Sha, YANG Hongjun, JING Zhiwei, LI Geng. Safety Information in Oral Chinese Patent Medicine Instructions for Big Brand Traditional Chinese Medicine[J]. Chinese Journal of Pharmacovigilance, 2021, 18(10): 981-985.

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