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头三个月暴露于局部维 A 酸类药物后妊娠结局:系统评价和荟萃分析。

Pregnancy outcomes following first-trimester exposure to topical retinoids: a systematic review and meta-analysis.

机构信息

TERAFAR - Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey.

The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, The Hospital for Sick Children and University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.

出版信息

Br J Dermatol. 2015 Nov;173(5):1132-41. doi: 10.1111/bjd.14053. Epub 2015 Oct 19.

Abstract

Evaluation of human data regarding the outcomes of topical-retinoid-exposed pregnancies is important in terms of counselling pregnant women with inadvertent exposure. The objective of this study was thus to determine whether exposure to topical retinoids leads to an increase in the risk of adverse pregnancy outcomes. We carried out a search using the Medline, Embase, Web of Science and Cochrane Central Register of Controlled Trials databases from inception to 4 December 2014. The selection, review and quality assessment of the studies were carried out by two independent reviewers according to predetermined inclusion criteria. Odds ratios (ORs) were calculated by the random effects method. This meta-analysis, including a total of 654 pregnant women who were exposed to topical retinoids, and 1375 unexposed control pregnant women, did not detect significant increases in rates of major congenital malformations [OR 1·22, 95% confidence interval (CI) 0·65-2·29], spontaneous abortions (OR 1·02, 95% CI 0·64-1·63), stillbirth (OR 2·06, 95% CI 0·43-9·86), elective termination of pregnancy (OR 1·89, 95% CI 0·52-6·80), low birthweight (OR 1·01, 95% CI, 0·31-3·27) or prematurity (OR 0·69, 95% CI 0·39-1·23). No significant heterogeneity was detected among the studies for the evaluated outcomes. The present meta-analysis ruled out a major increase in the rates of major congenital malformations, spontaneous abortions, low birthweight and prematurity. This result may be used primarily in reassuring women who were inadvertently exposed to topical retinoids during their pregnancy. However, the statistical power is not adequate to justify the use of topical retinoids during pregnancy.

摘要

评估局部维 A 酸暴露妊娠结局的人体数据对于意外暴露的孕妇咨询非常重要。因此,本研究旨在确定局部使用维 A 酸是否会增加不良妊娠结局的风险。我们使用 Medline、Embase、Web of Science 和 Cochrane 对照试验中心注册数据库从建库至 2014 年 12 月 4 日进行了检索。根据预先确定的纳入标准,由两名独立评审员进行研究的选择、审查和质量评估。采用随机效应法计算比值比(OR)。本 meta 分析共纳入 654 名局部暴露于维 A 酸的孕妇和 1375 名未暴露于维 A 酸的对照孕妇,未发现主要先天畸形(OR 1·22,95%CI 0·65-2·29)、自然流产(OR 1·02,95%CI 0·64-1·63)、死胎(OR 2·06,95%CI 0·43-9·86)、选择性终止妊娠(OR 1·89,95%CI 0·52-6·80)、低出生体重(OR 1·01,95%CI 0·31-3·27)或早产(OR 0·69,95%CI 0·39-1·23)的发生率显著增加。对于评估的结局,研究之间没有显著的异质性。本 meta 分析排除了主要先天畸形、自然流产、低出生体重和早产发生率的显著增加。这一结果可能主要用于减轻意外暴露于局部维 A 酸的孕妇的担忧。然而,统计效力不足以证明在怀孕期间使用局部维 A 酸是合理的。

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