孕期暴露于异维甲酸后严重畸形的发生率：一项系统评价和荟萃分析。
The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis.
作者信息
Choi Eun Jeong, Kim NaeRy, Kwak Ho-Seok, Han Hae Ji, Chun Kyoung-Chul, Kim Young-Ah, Koh Jae-Whoan, Han Jung Yeol, Joo Sung Hong, Lee Ji Sung, Koren Gideon
机构信息
Korean Mothersafe Counselling Center, Pregnancy & Breastfeeding Medicines Information Center, Seoul, Korea.
Department of Obstetrics and Gynecology, Inje University Ilsan Paik Hospital, Goyang, Korea.
出版信息
Obstet Gynecol Sci. 2021 Jul;64(4):364-373. doi: 10.5468/ogs.20373. Epub 2021 Mar 17.
OBJECTIVE
Isotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% of malformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM) among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis.
METHODS
Eligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis of odd ratios among controlled studies were performed using Review Manager version 5.3.
RESULTS
Ten eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MM weighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible for the meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooled odds ratio of MM for isotretinoin exposure was significantly lower at 1.04.
CONCLUSION
The current rate of MM in isotretinoin-exposed women was substantially lower after 2006.
目的
异维甲酸是最臭名昭著的人类致畸剂之一，最初记录显示其致畸率高达30%。本系统评价和荟萃分析旨在通过系统评价和荟萃分析评估多年来暴露于异维甲酸的孕妇中严重畸形（MM）的发生率。
方法
使用各种数据库检索并识别符合条件的研究。使用Review Manager 5.3软件进行单臂荟萃分析以及对照研究中比值比的荟萃分析。
结果
我们的研究纳入了10项符合条件的研究，共涉及2783名暴露于异维甲酸的女性。按样本量加权后的MM发生率为15%。三项纳入未暴露对照组的研究符合荟萃分析条件。暴露于异维甲酸的女性发生MM的合并比值比为3.76。2006年后，暴露于异维甲酸的女性发生MM的合并比值比显著降低，为1.04。
结论
2006年后，暴露于异维甲酸的女性当前的MM发生率大幅降低。
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