Analysis of adverse reaction characteristics of PD-1 inhibitors in Shandong Province based upon real-world monitoring data
OBJECTIVE To excavate the patterns and characteristics of adverse reactions of PD-1 inhibitors and provide rationales for patient medication safety.METHODS The adverse reactions of PD-1 inhibitor collected by Shandong ADR Moni-toring Center from April 2019 to May 2023 were retrieved.Statistical analysis was performed on types of adverse reactions,sever ity,unintended or not,patient gender,age,outcome and involved organs/systems.RESULTS Among 1 056 reports of adverse reactions related to PD-1 inhibitors,males dominated(74.91％)with age mostly over 65 year(49.53％).A total of 18 system organ classifications(SOCs)and 1 672 preferred terms(PTs)were involved,with choking sensation as a PT not reported for any of the drugs.And 609 patients with severe ADR occurred,accounting for 57.67％.A comparison of different factors leading to severe adverse drug reaction revealed a significant statistical difference between group with serious adverse drug reactions and group with general adverse drug reaction during off-label drug uses and the previous of adverse drug reaction/event.CONCLUSION Clinicians should pay a high alert for the occurring patterns and characteristics of adverse reactions of PD-1 inhibitors and strengthen the monitoring of adverse drug reactions to ensure the safety of drug dosing.
PD-1 inhibitoradverse reactionsserious adverse drug reactionsdrug safety
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