摘要
目的为规范药品说明书提供信息。方法收集近2年来本院及附近医院临床常用药品说明书676份,进行汇总分析。结果部分国产西药和中成药说明书中的项目未能按国家规定标注,缺项严重。特别是药物过量、不良反应、禁忌证、孕妇及哺乳期用药、儿童用药、老年患者用药、药理毒性、药代动力学、注意事项、药物相互作用等10项内容缺项最多。进口药品说明书项目标注优于国产西药;国产西药优于中成药;注射制剂优于口服制剂;口服制剂优于外用制剂。结论不规范的药品说明书影响安全合理用药。
Objective To offer message for standardizing the drug package insert. Methods These material were collected in the recent two years, the package inserts of drugs in common use, the inserts were collected from our hospital and the hospitals near ours, they were in total number of 676 sheets. Results Part of domestic western medicines and the item in the Chinese traditional medicine manual could not press the nation provision to mark and lack a severity. Especially medicine surfeit, bad reaction, taboo certificate, pregnant woman and breast feed expect with the medicine, child with the medicine, old age sufferer with 10, such as the dynamics, regulation of the medicine, pharmacology toxicity, medicine generation and medicine interaction, etc. lack an item at most. Drugs manual item＇s can press the nation provision what to mark is an importing medicine better than domestic western medicine. The domestic western medicine surpassed a Chinese herbal medicine. Inject better than take orally a product. Take orally a product a better than outside to use a product. Conclusions Nonstandard drugs package inserts influence rational drug use.
出处
《中国药事》
CAS
2009年第8期777-779,782,共4页
Chinese Pharmaceutical Affairs
关键词
药品说明书
调查
分析
规范
西药
中成药
package insert
investigate
analyze
standardization
western medicine
Chinese traditional medicine
