2011—2021年江苏省137例脾多肽注射液不良反应分析

Adverse reactions of spleen polypeptide injection in 137 cases in Jiangsu province during 2011-2021

目的:分析2011—2021年江苏省脾多肽注射液不良反应的发生规律和特点,为临床安全合理用药提供参考。方法:应用Excel 2010及手工检索方式,对2011—2021年江苏省137例脾多肽注射液不良反应的人口学特征、报告来源、报告类型、用药情况、累及系统/器官和临床表现进行统计和分析。结果:儿童和中老年患者不良反应占比较高;新的和严重的不良反应占比较高;用药剂量和方式符合说明书要求,90%患者在用药1周之内出现不良反应,无超适应证用药;不良反应累及系统/器官以皮肤及其附件占比最高,其他依次为全身反应、呼吸系统、消化系统、神经系统、心血管系统、运动系统和营养代谢系统。结论:2011—2021年江苏省脾多肽注射液临床使用规范,但应关注其新的和严重的不良反应及儿童和中老年等特殊人群用药,以提升用药安全性。

Objective:To analyze the occurrence regularity and characteristics of adverse drug reactions(ADR)of spleen polypeptide injection in Jiangsu province from 2011 to 2021 to provide reference for safe and rational drug use in clinic.Methods:In this study,137 cases of adverse reactions of splenic polypeptide injection in Jiangsu province from 2011 to 2021 were statistically analyzed using Excel 2010 software and manual retrieval method.The demographic characteristics,report sources,report types,medication status,involved systems/organs and clinical manifestations were analyzed.Results:The proportion of ADR was higher in children and middle-aged and elderly patients.New and serious ADR reports accounted for a relatively high proportion.The dosage and method of medication met the requirements of the drug labeling,90%patients had adverse reactions within one week of medication.There was no off-label medication.Skin and its appendages accounted for the highest proportion of involved system/organ,followed by systemic reaction system,respiratory system,digestive system,nervous system,cardiovascular system,motor system and nutritional metabolism system.Conclusion:The clinical use of spleen polypeptide injection was appropriate in Jiangsu province from 2011 to 2021,but new and serious adverse reactions should be paid more attention,and special populations such as children and middle-aged and elderly people should be paid more attention,so as to improve drug safety.