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2010－2020年我国中成药药品说明书修订情况分析
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| 篇名： | 2010－2020年我国中成药药品说明书修订情况分析 |
| TITLE： | Analysis on Revision of Chinese Patent Medicine Instructions in China from 2010 to 2020 |
| 摘要： | 目的：为进一步规范和完善中成药药品说明书、促进其临床安全合理使用提供依据。方法：查询国家药品监督管理局网站2010年1月－2020年6月发布的、药品说明书修订内容明确的中成药品种，归纳并分析修订内容、特点及不足，提出修改建议。结果与结论：在修订内容明确的107个中成药品种中，安全性项目为修订重点，修订“禁忌”项的有106个（占99.07％），修订“注意事项”项的有103个（占96.26％），修订“不良反应”项的有102个（占95.33％），修订“警示语”项的有49个（占45.79％）等。涉及修订的药品剂型主要为口服制剂，其次为注射剂和少量外用/直肠/阴道剂型。修订内容突出了中成药适用的中医证型，强调了含有毒性和化学药成分中成药的使用注意事项，细化了特殊人群用药注意事项；但也存在缺乏量化表述、缺乏系统全面的药物相互作用提示、其他未修订的相关项目也有待完善等问题。建议中成药说明书修订以安全用药为核心，提供明确的不良反应监测数据、清晰具体的用药注意、系统全面的药物相互作用，以促进中成药的安全合理使用。 |
| ABSTRACT： | OBJECTIVE：To furt her standardize and improve the drug instructions of Chinese patent medicine ，and to promote its clinical safe and rational use. METHODS ：The varieties of Chinese patent medicines with clear content revision issued by the website of the State Drug Administration from January 2010 to June 2020 were inquired. The revised contents ，characteristics and deficiencies were summarized and analyzed to put forward the revision suggestions. RESULTS & CONCLUSIONS ：Among 107 Chinese patent medicine varieties the instruction content of which were revised clearly ，safety items were the focus of revision ；106 types（99.07％）were revised in terms of “contraindications”，103 types（96.26％）were revised in terms of “precautions”，102 types（95.33％）were revised in terms of “ADR”，49 types（45.79％）were revised in terms of “warning words ”，etc. The main dosage forms involved in the revision were oral preparations ，followed by injections and a small amount of external/rectal/vaginal dosage forms. The revised content highlighted the TCM syndrome types applicable to Chinese patent medicine ，emphasized the precautions for the use of Chinese patent medicine containing toxic and chemical components and detailed the medication precautions for special groups. However ，there were still some problems ，such as lack of quantitative expression ，lack of systematic and comprehensive drug interaction tips ，and other related items that had not been revised needed to be improved. In order to promote the safe and rational use of Chinese patent medicine ，it is suggested that the revision of Chinese patent medicine instructions should focus on safe drug use ，provide clear ADR monitoring data ，clear and specific medication attention and systematic and comprehensive drug interaction. |
| 期刊： | 2021年第32卷第04期 |
| 作者： | 王晶 |
| AUTHORS： | WANG Jing |
| 关键字： | 中成药；药品说明书；合理用药；修订；分析 |
| KEYWORDS： | Chinese patent medicin e；Drug instructions ；Rational drug use ；Revision；Analysis |
| 阅读数： | 235 次 |
| 本月下载数： | 23 次 |
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