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阿奇霉素在新生儿中的使用与安全性：一项系统评价

Use and safety of azithromycin in neonates: a systematic review.

作者信息

Smith Coral, Egunsola Oluwaseun, Choonara Imti, Kotecha Sailesh, Jacqz-Aigrain Evelyne, Sammons Helen

机构信息

Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.

Department of Child Health, Institute of Molecular & Experimental Medicine, Cardiff University School of Medicine, Wales Heart Research Institute, Heath Park, UK.

出版信息

BMJ Open. 2015 Dec 9;5(12):e008194. doi: 10.1136/bmjopen-2015-008194.

DOI:10.1136/bmjopen-2015-008194
PMID:26656010
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4679913/
Abstract

OBJECTIVES

To identify the use and adverse drug reactions associated with azithromycin in neonates.

SETTING

Databases MEDLINE (1948-August 2015), EMBASE (1980-August 2015) and Pubmed (August 2015) were searched for studies on azithromycin in neonates.

PARTICIPANTS

All studies involving neonates (<28 days old) who have received at least a single dose of azithromycin for which safety was evaluated.

PRIMARY AND SECONDARY OUTCOME MEASURES

The primary outcome was adverse event (AE) associated with use of azithromycin. Use of azithromycin in neonates was the secondary outcome.

RESULTS

A total of 11 articles involving 473 neonates were identified. 371 AEs were reported. Adverse events were mainly respiratory (358/1000 neonate), neurological (273/1000 neonates) and gastrointestinal (196/1000 neonates) in origin. Azithromycin significantly reduced the risk of bronchopulmonary dysplasia (BPD) in extremely premature neonates (RR=0.83, 95% CI 0.71 to 0.98, p=0.02). There was no significant difference in the incidence of elevated liver enzymes between the azithromycin and placebo group (p=0.76). There were four cases of infantile hypertrophic pyloric stenosis (IHPS).

CONCLUSIONS

Azithromycin significantly reduces the risk of BPD in preterm neonates. The relationship between azithromycin and IHPS requires further investigation.

摘要

目的

确定阿奇霉素在新生儿中的使用情况及相关药物不良反应。

设置

检索数据库MEDLINE（1948年 - 2015年8月）、EMBASE（1980年 - 2015年8月）和Pubmed（2015年8月）中关于新生儿阿奇霉素的研究。

参与者

所有涉及接受至少单剂量阿奇霉素且对其安全性进行评估的新生儿（小于28天）的研究。

主要和次要结局指标

主要结局是与阿奇霉素使用相关的不良事件（AE）。新生儿使用阿奇霉素是次要结局。

结果

共识别出11篇涉及473例新生儿的文章。报告了371例不良事件。不良事件主要源于呼吸（每1000例新生儿中有358例）、神经（每1000例新生儿中有273例）和胃肠道（每1000例新生儿中有196例）。阿奇霉素显著降低了极早产儿支气管肺发育不良（BPD）的风险（RR = 0.83，95% CI 0.71至0.98，p = 0.02）。阿奇霉素组和安慰剂组之间肝酶升高的发生率无显著差异（p = 0.76）。有4例婴儿肥厚性幽门狭窄（IHPS）。

结论

阿奇霉素显著降低早产儿BPD的风险。阿奇霉素与IHPS之间的关系需要进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/d237f99e48f7/bmjopen2015008194f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/442f2552ee29/bmjopen2015008194f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/0cc5d4b9b078/bmjopen2015008194f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/2ed3b7732196/bmjopen2015008194f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/becef3720e10/bmjopen2015008194f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/d237f99e48f7/bmjopen2015008194f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/442f2552ee29/bmjopen2015008194f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/0cc5d4b9b078/bmjopen2015008194f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/2ed3b7732196/bmjopen2015008194f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/becef3720e10/bmjopen2015008194f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/51c9/4679913/d237f99e48f7/bmjopen2015008194f05.jpg

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Neonatology. 2014;106(4):337-47. doi: 10.1159/000363493. Epub 2014 Oct 1.
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