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喹诺酮类和氟喹诺酮类药物在妊娠中的安全性:一项荟萃分析。

The safety of quinolones and fluoroquinolones in pregnancy: a meta-analysis.

机构信息

Department of Obstetrics & Gynecology, Emek Medical Center, Afula, Israel.

Research Authority and Biostatistics, Emek Medical Center, Afula, Israel.

出版信息

BJOG. 2018 Aug;125(9):1069-1076. doi: 10.1111/1471-0528.15119. Epub 2018 Feb 22.

DOI:10.1111/1471-0528.15119
PMID:29319210
Abstract

BACKGROUND

Quinolones were contraindicated during pregnancy because of concerns regarding fetal malformations and carcinogenesis in animals. The literature is conflicting regarding their safety in humans.

OBJECTIVES

To conduct a meta-analysis evaluating the risk for fetal malformations and pregnancy complications following exposure to quinolones during pregnancy.

SEARCH STRATEGY

We searched Embase, PubMed, Medline, the Cochrane database, clinicaltrials.gov, and Dart Databases. We added articles found through the references of included articles.

SELECTION CRITERIA

Relevant English citations using the terms quinolone/s, fluoroquinolone/s, and pregnancy in humans. Exclusion criteria were case reports, reviews, and articles without data regarding the study outcomes.

DATA COLLECTION AND ANALYSIS

Two authors performed the database search, assessment of eligibility, and abstraction of data from included studies. Disagreement was settled by consensus among all authors. The pooled odds ratios (with 95% CIs) were estimated. The Cochrane's Q-test of heterogeneity and I² were used for the measurement of heterogeneity. A total of 256 papers were retrieved, 13 of which met the inclusion criteria and were then analysed.

MAIN RESULTS

No association was found between quinolones and fetal malformations (pooled odds ratio, OR 1.08; 95% CI 0.96-1.21), preterm delivery (pooled OR 0.97; 95% CI 0.75-1.24), stillbirth (pooled OR 1.11; 95% CI 0.34-3.6), or miscarriage (pooled OR 1.78; 95% CI 0.93-3.38).

CONCLUSIONS

Quinolones are not associated with unfavourable pregnancy outcomes; however, larger studies are needed before safety is established. Until then, it is suggested that quinolones should not be used as a first-line therapy during the first trimester.

TWEETABLE ABSTRACT

Quinolones were associated with favourable pregnancy outcomes; caution should be taken in the first trimester.

摘要

背景

由于担心喹诺酮类药物会导致胎儿畸形和动物致癌,因此在怀孕期间禁用喹诺酮类药物。关于其在人类中的安全性,文献存在争议。

目的

进行一项荟萃分析,评估怀孕期间接触喹诺酮类药物后胎儿畸形和妊娠并发症的风险。

检索策略

我们检索了 Embase、PubMed、Medline、Cochrane 数据库、clinicaltrials.gov 和 Dart 数据库。我们还添加了通过纳入文章参考文献找到的文章。

选择标准

使用喹诺酮/氟喹诺酮和人类妊娠等术语的相关英文引文。排除标准为病例报告、综述和没有研究结果数据的文章。

数据收集和分析

两名作者执行了数据库搜索、纳入标准评估和纳入研究数据提取。如有分歧,则由所有作者协商解决。汇总了(95%置信区间)的合并优势比(OR)。使用 Cochrane's Q 检验和 I²来衡量异质性。共检索到 256 篇论文,其中 13 篇符合纳入标准并进行了分析。

主要结果

未发现喹诺酮类药物与胎儿畸形(汇总 OR 1.08;95%CI 0.96-1.21)、早产(汇总 OR 0.97;95%CI 0.75-1.24)、死产(汇总 OR 1.11;95%CI 0.34-3.6)或流产(汇总 OR 1.78;95%CI 0.93-3.38)之间存在关联。

结论

喹诺酮类药物与不良妊娠结局无关;但需要更大规模的研究来确定其安全性。在此之前,建议在孕早期不要将喹诺酮类药物作为一线治疗药物。

推文摘要

喹诺酮类药物与良好的妊娠结局相关;在孕早期应谨慎使用。

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