《国家基本药物目录》中的中成药说明书项目若干问题探讨 点击下载
| 论文标题： | 《国家基本药物目录》中的中成药说明书项目若干问题探讨 |
| 英文标题： | |
| 中文摘要： | 目的：调查研究《国家基本药物目录》中的中成药说明书项目标注存在的问题，为中成药的合理应用、说明书修订提供依据。方法：搜集2018年版《国家基本药物目录》所载的268个中成药品种的不同剂型的465份说明书，统计分析药品说明书项目标注率及内容中存在的问题。结果：465份说明书中，注意事项标注率为86.88％，不良反应、药动学、禁忌、药物相互作用、临床试验、药理毒理、药理作用标注率低，分别为20.64％、0.21％、30.1％、1.07％、2.36％、8.81％、1.93％；其他项目全部标注。说明书成分项表述不完善，未完全列出所含中药饮片、辅料信息的分别占2.15％、48.81％；功能主治项表述不统一、不规范，共有12种表述方法，其中16.5％的主治项中缺乏中医适应证；规格项表述不统一、不规范，有5种表述方法；用法用量项标注不明确，且465份说明书都未提及老人、孕妇及哺乳期妇女的用法用量；药物相互作用、不良反应、注意事项、禁忌项表述不全面，无实质性内容，只有0.64％标注了与化学药的相互作用、12.68％标注了禁忌内容。结论：2018年版《国家基本药物目录》的中成药说明书项目存在表述不规范、不完整等问题。应加大力度建立健全中成药信息收集与反馈机制，出台政策支持企业开展上市后的基础和临床研究；并通过积极开展符合中医特色的基础和临床研究，以中医药理论为指导结合最新的研究成果，进一步完善中成药说明书内容。 |
| 英文摘要： | OBJECTIVE：To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ，and to provide reference for rational drug use and instruction revision. METHODS ：Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ，including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ，were collected ，and the labeling rate and content problems of drug instructions were counted. RESULTS ：Of the 465 instructions，86.88％ were labeled with cautions. The labeling rates of ADR ，pharmacokinetics，contraindications，drug interactions ， clinical trials ，pharmacological toxicology and pharmacological action were low ，being 20.64％，0.21％，30.1％，1.07％，2.36％， 8.81％，1.93％. All other items were labeled. Incomplete description of ingredients ，incomplete information of decoction pieces and excipients accounted for 2.15％ and 48.81％，respectively；the expression of functional indications was varied ，and there were 12 expression methods ，among which 16.5％ of indications lacked TCM indications ；specifications were not uniform ，and there were 5 expression methods ；usage and dosage were not clearly marked ，and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ，ADR，matters needing attention and contraindications were not fully described with no substantive content ；only 0.64％ marked interaction with chemical medicine and 12.68％ marked contraindication content. CONCLUSIONS ：There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ，such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ，and introduce policies to support enterprises to carry out basic and clinical research after listing ；and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ，guided by the theory of traditional Chinese medicine ，combined with the latest research results ，so as to further improve the contents of Chinese patent medicine instructions. |
| 期刊： | 2021年第32卷第13期 |
| 作者： | 李春晓，孙静雅，凌霄，李学林，赵娅，张博 |
| 英文作者： | LI Chunxiao ，SUN Jingya ，LING Xiao，LI Xuelin ，ZHAO Ya，ZHANG Bo |
| 关键字： | 国家基本药物目录；中成药说明书；合理用药；特殊人群用药 |
| KEYWORDS： | National Essential Medicine List ；Chinese patent medicine instruction ；Rational drug use ；Medication for special |
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