Goldstein D J, Corbin L A, Fung M C
Lilly Research Laboratories, Department of Pharmacology and Toxicology, Indiana University Medical School, Indianapolis, USA.
J Clin Psychopharmacol. 2000 Aug;20(4):399-403. doi: 10.1097/00004714-200008000-00002.
Psychosis frequently occurs in women of childbearing potential who may have unplanned pregnancies. Understanding the risk of prenatal antipsychotic exposure can be of benefit in selecting therapies. The authors evaluated the in utero and lactation exposure effects of olanzapine, a novel antipsychotic that is used in treating schizophrenia, bipolar disorder, and other conditions and that may have expanded use in the childbearing population. All prospectively and retrospectively ascertained pregnancy reports were collected as a registry in the Lilly Worldwide Pharmacovigilance Safety Database. Outcomes were available from 23 prospectively ascertained olanzapine-exposed pregnancies. Spontaneous abortion occurred in 13%, stillbirth in 5%, major malformation in 0%, and prematurity in 5%, all within the range of normal historic control rates. There were 11 retrospectively ascertained cases of pregnancy. Two retrospectively ascertained cases of lactation exposure did not suggest infant risk. The early experience with olanzapine use in pregnancy and lactation is encouraging in that no obvious added risk to the fetus or infant was observed. Additional cases of pregnancy and lactation exposure need to be evaluated to determine whether these early findings are representative of the risks of olanzapine exposure to the fetus and infant. At this time, olanzapine should only be used during pregnancy and lactation when the potential benefit justifies the potential risk to the fetus or infant.
精神病在有生育潜力的女性中经常发生，这些女性可能会意外怀孕。了解产前接触抗精神病药物的风险有助于选择治疗方法。作者评估了奥氮平在子宫内和哺乳期的接触影响，奥氮平是一种新型抗精神病药物，用于治疗精神分裂症、双相情感障碍和其他病症，并且在育龄人群中的使用可能会增加。所有前瞻性和回顾性确定的妊娠报告都作为礼来全球药物警戒安全数据库中的一个登记处收集。有23例前瞻性确定的接触奥氮平的妊娠结果可供分析。自然流产发生率为13%，死产率为5%，严重畸形率为0%，早产率为5%，所有这些都在正常历史对照率范围内。有11例回顾性确定的妊娠病例。两例回顾性确定的哺乳期接触病例未提示对婴儿有风险。奥氮平在妊娠和哺乳期的早期使用经验令人鼓舞，因为未观察到对胎儿或婴儿有明显的额外风险。需要评估更多的妊娠和哺乳期接触病例，以确定这些早期发现是否代表奥氮平接触胎儿和婴儿的风险。目前，只有当潜在益处大于对胎儿或婴儿的潜在风险时，奥氮平才能在妊娠和哺乳期使用。
