Adverse Drug Reaction Reports of Sintilimab Injection in Xiamen
Objective To provide a reference for the rational use of sintilimab in clinical practice.Methods The adverse drug reaction(ADR)reports of Sintilimab Injection reported by medical institutions in Xiamen to the National Adverse Drug Reaction Monitoring System from January 2021 to December 2023 were collected,the patients' basic information,medication history,systems and clinical manifestations affected by ADRs and outcomes were obtained,and the characteristics of ADR occurrence were analyzed by the Pareto chart.Results A total of 186 patients were involved,including 142 males(76.34%)and 44 females(23.66%).There were 210 case times of ADRs induced by sintilimab,including 110 case times of serious ADRs(52.38%).Pareto chart showed that the ADRs mainly involved the population over 50 years,the tumors of lung cancer and gastric cancer,and the patients receiving sintilimab combined with chemotherapy;the span of medication cycles involving ADRs was large(0-276 d),and the frequency of ADRs occurring in the first cycle(1-21 d)was the highest(68.10%);the ADRs mainly affected the blood system,digestive system and skin system,and most ADR clinical outcomes were improvement or recovery(80.96%).Conclusion The ADRs induced by sintilimab occur more frequently in male patients over 50 years,they can occur in the first cycle of medication and can affect multiple systems/organs(especially the blood,digestive,skin systems).We need to pay attention to early detection and timely intervention of the ADRs when using sintilimab in clinical practice.
sintilimabadverse drug reactionimmune checkpoint inhibitorPareto chart
万方数据
维普
