Systematic Review of Off-Label Drug Use in Hospitalized Neonates

Zhou Yiting; Zhang Yu; He Huayun; Hua Ziyu

doi:10.13407/j.cnki.jpp.1672-108X.2021.02.011

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Systematic Review of Off-Label Drug Use in Hospitalized Neonates

更新时间：2022-11-03

- Systematic Review of Off-Label Drug Use in Hospitalized Neonates
- Vol. 27, Issue 2, Pages: 34-39(2021)
- 作者机构：
  
  重庆医科大学附属儿童医院，儿童发育疾病研究教育部重点实验室，国家儿童健康与疾病临床医学研究中心，儿童发育重大疾病国家国际科技合作基地，儿科学重庆市重点实验室,重庆,400014
- 作者简介：
- 基金信息：
- DOI：10.13407/j.cnki.jpp.1672-108X.2021.02.011
  CLC：
- Published：2021，
  
  Published Online：10 February 2021，
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Zhou Yiting, Zhang Yu, He Huayun, et al. Systematic Review of Off-Label Drug Use in Hospitalized Neonates. [J]. 27(2):34-39(2021)
DOI：

Zhou Yiting, Zhang Yu, He Huayun, et al. Systematic Review of Off-Label Drug Use in Hospitalized Neonates. [J]. 27(2):34-39(2021) DOI： 10.13407/j.cnki.jpp.1672-108X.2021.02.011.

摘要

目的：系统评价住院新生儿超说明书用药研究现状，了解新生儿超说明书用药特点。方法：检索中国生物医学文献数据库、中国知网、维普、PubMed、EMbase数据库，纳入中英文发表的住院新生儿超说明书用药研究，以澳大利亚JBI循证卫生保健中心推荐的对现况调查类研究的质量评价工具评价纳入研究的质量，对同质研究采用R3.4.0软件进行Meta分析，分析超说明书用药的发生率、类型及相关药物种类构成。结果：共纳入22项研究，合计3 400例次住院新生儿，47 226条用药医嘱，其中超说明书用药医嘱26 172条（55.4%）。超说明书用药主要类型为“无儿童用药信息”用药、超剂量用药、超频次用药及超年龄用药；主要涉及药物种类为抗感染药物、神经系统药物、心血管系统药物；早产、重症监护病房新生儿更易发生超说明书用药。结论：住院新生儿超说明书用药现象普遍，可能会增加药物不良反应发生率，所以超说明书用药研究应关注药品不良反监测与评价，保障新生儿用药安全。

Abstract

Objective: To systematically evaluate the research status of off-label drug use in hospitalized neonates

and investigate the characteristics of off-label drug use. Methods: CBM

CNKI

VIP

PubMed and EMBase were retrieved to collect off-label drug use studies of hospitalized neonates published in Chinese and English. The quality of included studies was evaluated by using the quality assessment tool of the current situation survey studies recommended by Joanna Briggs Institute (JBI) evidence-based Health Care Center in Australia

and RevMan3.4.0 software was used for Meta-analysis of homogenous studies. The incidence and types of off-label drug use and composition of related drugs were analyzed. Results: A total of 22 studies were collected

including 3

400 neonates and 47

226 prescriptions

and there were 26

172 off-label drug use prescriptions. The main types of off-label drug use were “without medication information for children”

off-label dose

off-label frequency and off-label age drug use. The main types of drugs were anti-infective drugs

nervous system drugs and cardiovascular system drugs. Preterm delivery and neonates in intensive care units were more likely to have off-label drug use. Conclusion: Off-label drug use is common in hospitalized neonates

which may increase the incidence of adverse drug reactions. Therefore

the study of off-label drug use should focus on the monitoring and evaluation of adverse drug reactions to ensure the safety of drug use in neonates.

关键词

新生儿超说明书用药系统评价药物不良反应

Keywords

neonatesoff-label drug usesystematic reviewadverse drug reactions

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