| 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。 |
| 关键词: 新生儿 超说明书用药 系统评价 药物不良反应 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2021.02.011 |
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| 基金项目:重庆市2018 年科卫联合医学科研项目,编号2018MSXM063 |
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| Systematic Review of Off-Label Drug Use in Hospitalized Neonates |
| Zhou Yiting, Zhang Yu, He Huayun, Hua Ziyu |
| (Children’s Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, National Clinical Research Center for Child Health and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China) |
| 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. |
| Key words: neonates off-label drug use systematic review adverse drug reactions |
