药品评价
藥品評價
약품평개
DRUG REEVALUATION
2015年
6期
13-19
,共7页
FDA%妊娠%哺乳%用药标签%最终规则
FDA%妊娠%哺乳%用藥標籤%最終規則
FDA%임신%포유%용약표첨%최종규칙
FDA%Pregnancy%Lactation%Drug Labeling%Final rule
妊娠和哺乳作为女性的特殊生理时期，期间的用药安全问题尤为重要。孕期和哺乳期的临床用药决策的制定尤其复杂，需要考虑各种临床上和个人的因素，充分评估药物对母亲和胎儿的潜在益处和风险。本文对孕妇和哺乳期妇女的用药信息标签的演进及FDA 2014年最新颁布的关于孕妇和哺乳期妇女用药信息标签的最终规则进行介绍，目的是为我国完善药品标签说明提供参考价值。用药标签改进将帮助医生为孕妇、哺乳期妇女和分娩期间用药的风险/受益做出决策，减少或避免药物不良反应的发生。
妊娠和哺乳作為女性的特殊生理時期，期間的用藥安全問題尤為重要。孕期和哺乳期的臨床用藥決策的製定尤其複雜，需要攷慮各種臨床上和箇人的因素，充分評估藥物對母親和胎兒的潛在益處和風險。本文對孕婦和哺乳期婦女的用藥信息標籤的縯進及FDA 2014年最新頒佈的關于孕婦和哺乳期婦女用藥信息標籤的最終規則進行介紹，目的是為我國完善藥品標籤說明提供參攷價值。用藥標籤改進將幫助醫生為孕婦、哺乳期婦女和分娩期間用藥的風險/受益做齣決策，減少或避免藥物不良反應的髮生。
임신화포유작위녀성적특수생리시기，기간적용약안전문제우위중요。잉기화포유기적림상용약결책적제정우기복잡，수요고필각충림상상화개인적인소，충분평고약물대모친화태인적잠재익처화풍험。본문대잉부화포유기부녀적용약신식표첨적연진급FDA 2014년최신반포적관우잉부화포유기부녀용약신식표첨적최종규칙진행개소，목적시위아국완선약품표첨설명제공삼고개치。용약표첨개진장방조의생위잉부、포유기부녀화분면기간용약적풍험/수익주출결책，감소혹피면약물불량반응적발생。
It is particularly important for drug use during the period of pregnancy and lactation, which is the special physiological period for women. It is particularly complicated for clinical medical decision-making during pregnancy and lactation, and needs to consider the variety of clinical and personal factors, in order to fully evaluate the potential benefits and risks of the drug for the mother and fetus. In this manuscript, the evolution of the drug information label for pregnant and lactating women and thefinal rule of the drug information label issued by FDA in 2014 were introduced to provide references for the perfection of drug label instructions. Improved drug labels will help the doctors to make decisions about risk/benefit during medication for pregnant women, nursing mothers and women during childbirth, so as to reduce or avoid the occurrence of adverse drug reactions.
