A Systematic Review Of Off-label Studies In Hospitalized Neonates

Objectives: To systematically evaluate the status and to investigate the characteristics of off-label drug use among hospitalized neonates.Methods: The database CBM,CNKI,VIP,PubMed,EMbase were searched,published in Chinese and English,the evaluation tool was Australia JBI evidence-based health care center recommended to evaluate the quality of survey research,R3.4.0 was used to perform a Meta analysis of randomized controlled trials,descriptively analysis OL types and OL drug species composition ratio.Results: A total of 22 studies were included,including 3,400 neonates and 47,226 prescriptions,26,172 OL prescriptions.Analysis of the composition ratio of off-label drug types showed that among the studies classified as "no drug information for children",the composition ratio of this type was the largest.Meanwhile,in the studies without this type,the top types of newborn OL were overdose,over-frequency and overage,respectively.Systemic anti-infective drugs,nervous system drugs and cardiovascular system drugs were the main types of neonatal OL drugs.The neonates of premature and NICU may be more likely to be treated with OL drugs.Conclusions: More than 90% of hospitalized neonates accepted OL drug,probably resulting in increased incidence of adverse drug reactions.Therefore,ADR monitoring and evaluation system might become the focus of OL related study in the future,enabling the safety of neonatal drug use.