摘要
目的:本文通过对17种抗抑郁药说明书关于潜在生育人群的修改情况进行调查对比,分析FDA新孕妇用药规则正式实行后抗抑郁药的说明书修改情况,通过临床药学方法为临床提供更为详细的用药策略。方法:本课题分别对17种抗抑郁药的中文说明书、英文说明书和Micromedex进行检索对比,调查目前抗抑郁药说明书的修改情况;通过不同种属间体表面积换算,利用动物实验数据为临床用药提供药学服务。结果:目前17种抗抑郁药均已除去ABCDX字母分类法,关于潜在生育人群17种药物未进行增补;目前有11种抗抑郁药具备大鼠生殖毒性实验;体表面积换算结果显示对生育力存在影响的药物中,2倍MRHD(人体推荐最大剂量)剂量药物5种,2~5倍MRHD剂量药物6种,5~10倍MRHD剂量药物2种,10倍MRHD药物共4种。结论:FDA新孕妇用药规则实行后,17种抗抑郁药的说明书均已除去ABCDX字母分类,但关于潜在生育人群均未进行修改,通过临床药学方法,可以为临床工作者提供更为详尽的用药信息。
Objective： To investigate the changes in labeling of 17 antidepressants on ＂Females and males of reproductive potential＂, we collected and summarized the labeling and Micromedex instructions of the antidepressants. Through dose conversion between rats and humans, we conducted more detailed strategies for clinicians and pharmacists. Methods： Chinese and English labeling of 17 antidepressants on ＂Females and males of reproductive potential＂ and ＂impairment of fertilities＂ were collected and compared. The diagram of toxic dose of antidepressants was developed based on the dose conversion and provided more information on the pharmacy strategies. Results： All ABCDX letter categories of 17 antidepressants had been moved, and no addition on the ＂Females and males of reproductive potential＂ was showed. There were 5 antidepressants below 2 times of MRHD （ maximum recommended human dose）, 6 between 2-5 times of MRHD, 2 between 5-10 times of MRHD, 4 above 10 times of MRHD. Conclusion： All A BCDX letter categories of 17 antidepressants had been moved since PLLR was published by FDA, however, the content of＂Females and males of reproductive potential＂ was not updated in labeling. Pharmacist with clinical pharmacy knowledge is expected to provide more details for the clinicians on antidepressants.
出处
《临床药物治疗杂志》
2017年第2期28-32,共5页
Clinical Medication Journal
关键词
抗抑郁药
潜在生育人群
生殖毒性
剂量换算
antidepressants
females and males of reproductive potential
impairment of fertilities
dose conversion
