319例注射用脑蛋白水解物药品不良反应报告分析

Analysis of 319 cases of adverse drug reaction induced by cerebroprotein hydrolysate for injection

目的 分析注射用脑蛋白水解物不良反应报告数据,了解该药品不良反应发生特点,为临床安全用药提供参考。方法 采用回顾性研究,对2011年1月1日至2022年12月31日收集到的注射用脑蛋白水解物不良反应报告进行分析。结果 319例注射用脑蛋白水解物不良反应累计598例次,多发生于61岁以上患者,不良反应发生时间多为用药30 min内,不良反应累及系统-器官主要为皮肤及其附件疾病、胃肠疾病、呼吸系统疾病等。严重报告56例,不良反应主要表现为过敏样反应。结论 临床应警惕注射用脑蛋白水解物引起的不良反应,规范临床用药,防止过敏性休克严重不良反应的发生。

Objective To analyze the adverse drug reactions(ADR)induced by cerebroprotein hydrolysate for injection and to find out about the characteristics of such ADR so as to provide data for safe clinical use of cerebroprotein hydrolysate for injection.Methods Data on ADR of cerebroprotein hydrolysate for injection between 2011 and 2022 was collected by Qujing Food and Drug Adverse Reaction and Drug Abuse Monitoring Center.Results Most of the 319 cases of adverse reaction caused by cerebroprotein hydrolysate for injection occurred in patients over 61 years old.Adverse reaction usually occurred within 30 minutes of medication and manifested themselves in skin and appendages disorders,gastrointestinal disorders,and respiratory disorders.There were a total of 56 cases of severe ADR that were characterized by anaphylactoid reaction and anaphylactic shock.Conclusion Clinicians should be alert to ADR caused by cerebroprotein hydrolysate for injection in clinical practice,standardize clinical medication,prevent the occurrence of such serious adverse reactions as anaphylaxis.