166份抗糖尿病药品说明书中妊娠妇女用药信息标注情况调查分析 点击下载
论文标题： 166份抗糖尿病药品说明书中妊娠妇女用药信息标注情况调查分析
英文标题：
中文摘要： 目的：为规范抗糖尿病药品说明书中妊娠妇女用药信息标注提供参考。方法：收集丁香园用药助手中收录的所有抗糖尿病药品说明书，分析其中妊娠妇女用药信息标注情况。结果：166份药品说明书中，147份（88.55％）有单独列出“孕妇及哺乳期妇女用药”项，并对妊娠妇女用药信息进行了标注；14份（8.43％）也有列出该项，但仅标注尚无临床资料或临床资料有限，未提示妊娠妇女可否用药；5份（3.01％）无“孕妇及哺乳期妇女用药”项。在无用药指导意见中，指导意见缺失3份（1.81％），临床资料无/有限14份（8.43％）；在有用药指导意见中，指导意见为禁用49份（29.52％），不得/不宜/不应使用40份（24.1％），慎用/不推荐/权衡利弊/益处大于风险时使用/向医师咨询49份（29.52％），可用/使用不受限制11份（6.63％）。166份药品说明书中，26份为国外药企药品说明书，均有单独列出“孕妇及哺乳期妇女用药”项，且有妊娠妇女用药指导意见。结论：国内药品说明书标注内容存在妊娠妇女用药相关信息缺失、指导意见表述不统一、更新滞后等问题，应引起药品监督管理部门、药品生产企业的重视。
英文摘要： OBJECTIVE： To provide reference for specified labeling of medication information on pregnant women in drug instructions of anti-diabetic drugs. METHODS： All of drug instructions of anti-diabetic drugs in DXY Drugs Information were collected， the medication information labeling on pregnant women was analyzed. RESULTS： Among 166 drug instructions， 147 （88.55％） had listed the item of “drug use for pregnant and lactating women” alone， and labeled with the drug information on pregnant women； 14 （8.43％） had listed the item too， but labeled with no or limited clinical data， and whether pregnant women could use or not was not suggested； 5 （3.01％） didn’t have the item. About without guidance of drug use， there were 3 （1.81％） drug instructions missed guidance， and 14 （8.43％） with no or limited clinical data. About with guidance of drug use， 49 （29.52％） were labeled with forbidden for pregnant women； 40 （24.1％） were labeled with can’t/not suitable/should not be used for pregnant women； 49 （29.52％） were labeled with cautious/not recommend/weighed the pros and cons/benefits greater than the risk/consulted a doctor for pregnant women； and 11 （6.63％） were labeled with being safe/being not restricted for pregnant women. In the 166 drug instructions， 26， which were from foreign pharmaceutical companies， had listed the item of “drug use for pregnant and lactating women” alone， as well as labeled the guidance of drug use for pregnant women. CONCLUSIONS： The labeling of domestic drug instructions shows inadequate drug information on pregnant women， non-uniform guidance statements， lag of update and other problems， which should be attached to great importance by drug supervision and management departments， as well as pharmaceutical production enterprises.
期刊： 2017年第28卷第16期
作者： 冯娜
英文作者： FENG Na
关键字： 药品说明书；抗糖尿病药；妊娠妇女
KEYWORDS： Drug instruction； Anti-diabetic drug； Pregnant women
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