Analysis of Adverse Drug Reactions in 182 Neonates

doi:10.19803/j.1672-8629.2021.05.15

Abstract

Abstract: Objective To explore the causes, characteristics and influencing factors of adverse drug reactions (ADR) in neonates in order to reduce neonatal ADR and promote rational clinical use of drugs in neonates. Methods The 182 cases of ADR in neonates reported by our hospital between October 1, 2006 and December 31, 2019 were statistically analyzed. The ADR severity index (SIADR)of various drugs was calculated. Results The ratio of boys and girls was 2.57∶1. The main drugs that caused ADR in newborns were antibacterial drugs, nervous system drugs, and traditional Chinese medicine preparations. However, the three drugs with the highest SIADR were sedative and hypnotic drugs, blood system drugs and electrolytes, acid-base balance and nutritional drugs. The most common ADR were injuries to the skin and its appendants. Off-label drug use and irrational drug use were found during clinical medication of neonates. Conclusion ADR among neonates are closely related to gender, neonatal pharmacokinetics, off-label drug use and irrational drug use. Drugs with a high severity index deserve attention in clinical use. The following measures are recommended to reduce the incidence of neonatal ADR and promote the rational use of drugs: investing more in the study on neonatal pharmacokinetics, boosting R&D of special drugs for newborns; and to promote rational antibacterial drugs use.

Key words: neonates, adverse drug reactions, adverse drug reaction severity index, （SIADR）, rational drug use

CLC Number:

R969.3

LI Jing, PENG Cuiying, LUO Fangmei, ZHANG Haixia. Analysis of Adverse Drug Reactions in 182 Neonates[J]. Chinese Journal of Pharmacovigilance, 2021, 18(5): 473-477.

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