Antibiotic use in pregnancy and lactation - What is and is not known about teratogenic and toxic risks
Antibiotic use in pregnancy and lactation - What is and is not known about teratogenic and toxic risks
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DOI：
10.1097/01.aog.0000216197.26783.b5
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发表时间：
2006-05-01
影响因子：
7.2
通讯作者：
Kennedy, Dianne L.
中科院分区：
文献类型：
--
作者：
Nahum, Gerard G.;Uhl, Kathleen;Kennedy, Dianne L.
目的：在美国，任何时候都有超过1000万的妇女怀孕或哺乳。这些妇女使用药物的风险是独特的。除了改变药物药代动力学的正常生理变化外，还存在对发育中的胎儿和新生儿可能的致畸和毒性作用的担忧。本文综述了11种广谱抗生素的风险和药代动力学考虑因素，这些抗生素可用于治疗妊娠和哺乳期间的常规和危及生命的感染。来自美国食品药品监督管理局（FDA）产品标签、致畸剂信息服务、REPROTOX、谢泼德致畸剂目录、临床药理学的信息，并对同行评议的医学文献进行了综述，涉及11种抗生素在妊娠和哺乳期妇女中的使用。使用PubMed搜索引擎，检索词为“[抗生素名称]与妊娠”、“[抗生素名称]与哺乳”和“[抗生素名称]与母乳喂养”，检索时间为1940年1月至2005年11月，以及标准参考文献追踪。124篇参考文献有足够的关于受试者数量、方法和结果的信息。和结果：在人体中的致畸潜力范围从“无”（青霉素G和VK）到“不太可能”（阿莫西林、氯霉素、环丙沙星、多西环素、左氧氟沙星和利福平）到“未确定”（克林霉素、庆大霉素和万古霉素）。评估基于“良好数据”（青霉素G和VK）、“一般数据”（阿莫西林、氯霉素、环丙沙星、多西环素、左氧氟沙星和利福平）、“有限数据”（克林霉素和庆大霉素）和“非常有限数据”（万古霉素）。青霉素类、氟喹诺酮类和庆大霉素在妊娠期间发生了显著的药代动力学变化，表明可能需要调整这些药物的剂量。除氯霉素，所有这些抗生素被认为是兼容的母乳喂养。结论：卫生保健专业人员应考虑的致畸性和毒性的风险概况的抗生素，以协助孕妇和哺乳期妇女的处方决定。如果需要采取抗感染对策，以保护接触生物恐怖主义行为可能造成的致病性细菌制剂的个人的健康、安全和生存，这些措施可能变得特别重要。
OBJECTIVE: Over ten million women are either pregnant or lactating in the United States at any time. The risks of medication use for these women are unique. In addition to normal physiologic changes that alter the pharmacokinetics of drugs, there is the concern of possible teratogenic and toxic effects on the developing fetus and newborn. This article reviews the risks and pharmacokinetic considerations for 11 broad-spectrum antibiotics that can be used to treat routine and life-threatening infections during pregnancy and lactation.DATA SOURCES: Information from the U.S. Food and Drug Administration (FDA) product labels, the Teratogen Information Service, REPROTOX, Shepard's Catalog of Teratogenic Agents, Clinical Pharmacology, and the peer-reviewed medical literature was reviewed concerning the use of 11 antibiotics in pregnant and lactating women. The PubMed search engine was used with the search terms "[antibiotic name] and pregnancy," "[antibiotic name] and lactation," and "[antibiotic name] and breastfeeding" from January 1940 to November 2005, as well as standard reference tracing.METHODS OF STUDY SELECTION: One hundred twenty-four references had sufficient information concerning numbers of subjects, methods, and findings to be included.TABULATION, INTEGRATION, AND RESULTS: The teratogenic potential in humans ranged from "none" (penicillin G and VK) to "unlikely" (amoxicillin, chloramphenicol, ciprofloxacin, doxycycline, levofloxacin, and rifampin) to "undetermined" (clindamycin, gentamicin, and vancomycin). Assessments were based on "good data" (penicillin G and VK), "fair data" (amoxicillin, chloramphenicol, ciprofloxacin, doxycycline, levofloxacin, and rifampin), "limited data" (clindamycin and gentamicin), and "very limited data" (vancomycin). Significant pharmacokinetic changes occurred during pregnancy for the penicillins, fluoroquinolones and gentamicin, indicating that dosage adjustments for these drugs may be necessary. With the exception of chloramphenicol, all of these antibiotics are considered compatible with breastfeeding.CONCLUSION: Health care professionals should consider the teratogenic and toxic risk profiles of antibiotics to assist in making prescribing decisions for pregnant and lactating women. These may become especially important if anti-infective countermeasures are required to protect the health, safety, and survival of individuals exposed to pathogenic bacteriologic agents that may occur from bioterrorist acts.