Chambers C D, Polifka J E, Friedman J M
Department of Pediatrics, University of California, San Diego School of Medicine, La Jolla, California, USA.
Clin Pharmacol Ther. 2008 Jan;83(1):181-3. doi: 10.1038/sj.clpt.6100448. Epub 2007 Dec 12.
Although clinical trials address questions regarding drug safety for most segments of the population, pregnant women constitute one special group that is "orphaned" with respect to this issue. The lack of adequate pregnancy safety information for the vast majority of medications, combined with a need to make appropriate treatment decisions and to communicate risk information to a potentially vulnerable population, are some of the most challenging and critical women's health issues.
尽管临床试验解决了针对大多数人群的药物安全性问题,但孕妇是在这一问题上被“忽视”的一个特殊群体。绝大多数药物缺乏足够的孕期安全性信息,再加上需要做出恰当的治疗决策并向潜在的脆弱人群传达风险信息,这些都是最具挑战性和关键性的女性健康问题。