xx医院门诊口服中成药说明书情况调查与分析.doc
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xx医院门诊口服中成药说明书情况调查与分析,摘要:目的 调查中成药说明书中各项目的缺失情况及其内容的完整性,提高临床用药的合理性，进一步完善中成药说明书。方法 收集xx医院门诊口服中成药说明书共127张，参照《药品说明书和标签管理规定》及《关于中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知》中的有关规定，...
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xx医院门诊口服中成药说明书情况调查与分析
摘要:目的 调查中成药说明书中各项目的缺失情况及其内容的完整性,提高临床用药的合理性，进一步完善中成药说明书。方法 收集xx医院门诊口服中成药说明书共127张，参照《药品说明书和标签管理规定》及《关于中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知》中的有关规定，对127份中成药说明书的所有项目标注情况、安全项及特殊人群用药项进行统计分析。结果 127份中成药说明书中项目标注情况上，警示语、药物相互作用、临床试验等项目缺失率较高；特殊人群用药项上，只有一份说明书将儿童用药、老年用药、孕妇及哺乳期妇女用药作为单独一项列出，孕妇及哺乳期妇女用药在别项中提到比率较高；安全项标注情况较完整，标注率均接近100%，但其内容缺乏完整性。结论 中成药说明书中仍存在许多不足，我们要提高警惕，进一步完善中成药说明书。
关键词: 中成药说明书；标注情况；特殊人群用药；安全项调查
The ninth hospital outpatient proprietary Chinese medicine oral instruction situation investigation and analysis
Abstract: Objective to investigate the lack of integrity and the content of each item of proprietary Chinese medicines in the specification, improve the rationality of clinical medicine, to further improve the Chinese patent medicines. Methods the data of nine five hospital outpatient oral Chinese patent medicines, a total of 127, according to "drug instructions and labeling regulations" and "Regulations on traditional Chinese medicine, natural medicine prescription drug instruction format requirement of writing content and notice" writing guidelines in 127 Chinese patent medicines, for all items, safety and drug use in special populations a statistical analysis. Results of the 127 projects in the Chinese traditional medicine manual annotation status, lack of a higher rate of warnings, drug interaction, clinical trials and other projects; drug use in special populations item, only a description will use for children, elderly patients, pregnant and lactating women use as a separate item list, pregnant and lactating women use mentioned higher ratios in don't item; security label is complete, labeling rate is close to 100%, but its content is lack of integrity. There are still many problems conclusion Chinese medicine instructions, we must be vigilant, to further improve the Chinese patent medicines.
Keywords: Proprietary Chinese medicine specifications; the mark; Special populations medication; Safety survey
摘要:目的 调查中成药说明书中各项目的缺失情况及其内容的完整性,提高临床用药的合理性，进一步完善中成药说明书。方法 收集xx医院门诊口服中成药说明书共127张，参照《药品说明书和标签管理规定》及《关于中药、天然药物处方药说明书格式内容书写要求及撰写指导原则的通知》中的有关规定，对127份中成药说明书的所有项目标注情况、安全项及特殊人群用药项进行统计分析。结果 127份中成药说明书中项目标注情况上，警示语、药物相互作用、临床试验等项目缺失率较高；特殊人群用药项上，只有一份说明书将儿童用药、老年用药、孕妇及哺乳期妇女用药作为单独一项列出，孕妇及哺乳期妇女用药在别项中提到比率较高；安全项标注情况较完整，标注率均接近100%，但其内容缺乏完整性。结论 中成药说明书中仍存在许多不足，我们要提高警惕，进一步完善中成药说明书。
关键词: 中成药说明书；标注情况；特殊人群用药；安全项调查
The ninth hospital outpatient proprietary Chinese medicine oral instruction situation investigation and analysis
Abstract: Objective to investigate the lack of integrity and the content of each item of proprietary Chinese medicines in the specification, improve the rationality of clinical medicine, to further improve the Chinese patent medicines. Methods the data of nine five hospital outpatient oral Chinese patent medicines, a total of 127, according to "drug instructions and labeling regulations" and "Regulations on traditional Chinese medicine, natural medicine prescription drug instruction format requirement of writing content and notice" writing guidelines in 127 Chinese patent medicines, for all items, safety and drug use in special populations a statistical analysis. Results of the 127 projects in the Chinese traditional medicine manual annotation status, lack of a higher rate of warnings, drug interaction, clinical trials and other projects; drug use in special populations item, only a description will use for children, elderly patients, pregnant and lactating women use as a separate item list, pregnant and lactating women use mentioned higher ratios in don't item; security label is complete, labeling rate is close to 100%, but its content is lack of integrity. There are still many problems conclusion Chinese medicine instructions, we must be vigilant, to further improve the Chinese patent medicines.
Keywords: Proprietary Chinese medicine specifications; the mark; Special populations medication; Safety survey
