妊娠期妇女用药说明书的特殊人群标注及与药学数据库的比较  

Safety information for pregnant women in drug instructions and drug information databases

作　　者：何晓静[1] 季颖 李晓冰[1] 菅凌燕[1] HE Xiao-jing;JI Ying;LI Xiao-bing;JIAN Ling-yan(Department of Pharmacy,Shengjing Hos-pital of China Medical University,Shenyang 110004,China;Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004 [2]沈阳药科大学,沈阳110016

出　　处：《实用药物与临床》2018年第9期1077-1080,共4页Practical Pharmacy and Clinical Remedies

基　　金：2013/2014国家临床药学重点专科建设项目

摘　　要：目的掌握妇女妊娠期常用药物的用药安全信息并比较其与药学数据库信息的差异,为妊娠期的妇女合理用药提供正确的参考意见。方法通过收集中国医科大学附属盛京医院2016年9月至2017年3月妇产科门急诊处方中常用药物135种,对所收集的药物说明书中妊娠期的用法用量、用药安全、药代动力学进行分析,并分析其与TOXNET数据库和MICROMEDEX SOLUTIONS数据库内容的差异。结果 135种本院妊娠女性患者常用药品的说明书"妊娠期的用法用量"项标注的统计中,标注率为15. 6%;在"妊娠期用药安全"项标注的统计中,排名前3位的分别是"标注"、"无"、"尚不明确",标注率分别是55. 6%、17. 0%、14. 8%,在"妊娠期药代动力学"项标注的统计中,标注率为6. 7%。化学药的说明书中妊娠期用药安全标注率明显高于中成药(P <0. 05);进口化学药的说明书中妊娠期的用法用量、用药安全和药代动力学标注率均明显高于国产化学药(P <0. 05)。与药品说明书比较,TOXNET和MICROMEDEX SOLUTIONS数据库提供信息更及时全面。结论药品说明书中存在"妊娠期妇女用药安全"相关内容缺失的问题。药师既要掌握药品说明书,又要及时了解国内外数据库有关药品信息,才能更好地为患者提供合理用药服务。Objective To acknowledge the safety information and compare it with databases to provide ration- al references for pregnant women. Methods Through collecting 135 kinds of common drug instructions used in gyne- cological clinic and emergency department of the Shengjing Hospital of Chinese Medical University from September 2016 to March 2017,we analyzed dosage, safety information and pharmacokinetics in drug instructions, and compared drug instructions with TOXNET and MICROMEDE SOLUTIONS databases. Results Among 135 kinds of drug in- structions, there was 15.6% with dosage for pregnant women. As for safety information for pregnant women in drug in- structions,the label of ＂ yes＂ ,＂ none＂ and ＂ unclear＂ were the top three, the percentage being 55.6%, 17. 0% and 14. 8,respectively. As for pharmacokinetics for pregnant women in drug instructions, there was only 6. 7% being la- belled. Compared with the traditional Chinese medicine, there was much more safety information in chemicals （ P 〈 0. 05 ）. Also, compared with domestic chemicals, there was more information on the dosage, safety and pharmacokinet- ics of drugs for pregnant women in imported chemicals （P 〈 0. 05 ）. Compared with drug instructions, drug informationdatabases could supply more timely and comprehensive information. Conclusion Most drug instructions don＇t provide information on dosage,safety and pharmacokinetics for pregnant women. In order to provide better pharmacy services for patients,pharmacist should master knowledge of drug instructions and learn the drug information in databases in time.

关 键 词：药品说明书 药学信息数据库 妊娠女性 合理用药 

分 类 号：R969.3[医药卫生—药理学]