Diav-Citrin O, Okotore B, Lucarelli K, Koren G
Department of Pediatrics, Research Institute, the Hospital for Sick Children and the University of Toronto, Ontario, Canada.
Am J Perinatol. 1999;16(4):157-60. doi: 10.1055/s-2007-993850.
BACKGROUND & AIM: Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic. To date, no published data exist regarding human pregnancy experience with zopiclone. The purpose of this study was to compare pregnancy outcome following first-trimester exposure to zopiclone with that of a matched control group of women, who were counseled for nonteratogenic exposure.
The Motherisk Program, the Toronto Teratogen Information Service, prospectively collected and followed up 40 women exposed to zopiclone during pregnancy. Pregnancy outcome was compared with that of a matched control group of women, who were counseled for nonteratogenic exposure.
There was no increase in the rate of major malformations (0 of 31 [0%] for zopiclone vs. 1 of 37 [2.7%] for nonteratogenic controls; p = 1).
Our study, which is the first cohort on zopiclone use during embryogenesis, albeit small, suggests that zopiclone does not appear to be a major human teratogen. Larger studies are needed to establish its safety during pregnancy.
佐匹克隆是一种环吡咯酮类衍生物，是一种短效催眠药。迄今为止，尚无关于佐匹克隆在人类孕期使用情况的公开数据。本研究的目的是比较孕早期暴露于佐匹克隆的孕妇与接受非致畸性暴露咨询的匹配对照组孕妇的妊娠结局。
多伦多致畸物信息服务机构的Motherisk项目前瞻性收集并随访了40名孕期暴露于佐匹克隆的女性。将妊娠结局与接受非致畸性暴露咨询的匹配对照组女性进行比较。
主要畸形率没有增加（佐匹克隆组31例中有0例[0%] vs. 非致畸性对照组37例中有1例[2.7%]；p = 1）。
我们的研究是关于胚胎发育期间使用佐匹克隆的首个队列研究，尽管样本量较小，但表明佐匹克隆似乎不是主要的人类致畸物。需要开展更大规模的研究来确定其在孕期的安全性。
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