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| 43份中药注射剂说明书的调查分析 |
| Investigation of 43 Package Inserts of Traditional Chinese Medicine Injection |
| 投稿时间：2011-10-12 修订日期：2012-01-05 |
| DOI： |
| 中文关键词: 中药注射剂 说明书 调查分析 |
| 英文关键词:Traditional Chinese medicine injection Instruction Investigation |
| 基金项目: |
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| 中文摘要: |
| 摘 要 目的：调查分析中药注射剂说明书内容完整性，为完善药品说明书提供参考依据。方法：收集本院43份中药注射剂说明书，依据有关说明书法律法规，关注其内容的完整性。结果：调查的43份说明书中，部分内容不完整，功能主治项仅用西医概念标注的有21份（48.8%）；用法用量项中未标注滴速有34份（79.1%）；未标注疗程的有25份（58.1%）；不良反应项内容不完整的有10份（23.3%）；35份标注老年用药内容不完整或没有（81.4%）、37份标注儿童用药内容不完整或没有（86.0%）、33例标注孕妇及哺乳期用药内容不完整或没有（76.8%）；药物相互作用内容不完整的有31份（72.1%）。结论：中药注射剂说明书仍需要不断完善，不完整说明书将会影响临床用药安全，导致不良反应发生。 |
| 英文摘要: |
| ABSTRACT Objective:To investigate and analyze the integrity of traditional Chinese medicine（TCM） injection’s instructions for their improvement.Method:43 portion instructions of TCM injection were collected and their integrity, analyzed according to related laws.Result:21 portions(48.8%) of the 43 portion instructions indicated the function and use of the prescription only with the concept of western medicine, but 34 portions(79.1%) did not indicate the dripping speed in the usage and dosage, 25 portion(58.1%) did not indicate the course of treatment, 10 portion(23.3%) had their incomplete content about adverse drug reaction, 35 portion(81.4%) did not indicate they were the drug use in elderly, 37 portion (86.0%) did not indicate they were the drug use in children, 33 portion(76.8%) had no order for pregnancy and lactation, and 31 portion(72.1%) had incomplete interactions of drugs.Conclusion:TCM injection’s instructions must be continuously perfected because the incomplete drug instructions influenced the safety of clinical administration of medicine and resulted in the occurrence of adverse drug reactions. |
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