30013例悦安欣苦碟子注射液安全性医院集中监测

目的:获得悦安欣苦碟子注射液不良反应(ADR)发生率、发生特征和影响因素。方法:多中心、大样本、前瞻性医院集中监测方法,对使用悦安欣苦碟子注射液的住院患者进行监测。结果:在全国20家监测医院完成监测病例30013例。首例入组时间为2012年10月,末例结束监测为2015年8月,共发生ADR/ADE 50例,经过三级判定方法,判定ADR 43例,发生率为1.43‰,属于偶见不良反应(发生率1‰~1%)。其中新的ADR1例,表现为结膜出血;一般ADR共42例,不良反应表现为皮肤瘙痒、皮疹、头痛为主,累及全身8个不同系统损伤;无严重ADR。ADR多发生在用药当天30 min内,不良反应影响因素分析提示:年龄段为65以上,有过敏史,高浓度,有合并用药时应重点关注不良反应的发生。结论:安全性医院集中监测是获得中药注射剂不良反应发生率的有效途径,悦安欣苦碟子注射液的安全性良好。

Safety Report of 30 013 Yueanxin Kudiezi Injection Based on Centralized Hospital Monitoring

Objective:To obtain incidence,characteristics and influencing factors of adverse drug reactions(ADR)of Yueanxin Kudiezi Injection(YAX).Methods:A multi-center,large-sample,prospective hospital centralized monitoring method was used to monitor inpatients who used YAX.Results:A total of 30013 cases were monitored in 20 monitoring hospitals nationwide.The first case was enrolled in October 2012 and the last case was monitored in August 2015.ADR/ADE occurred in a total of 50 cases.After a three-level determination method,43 cases of ADR were determined with an incidence rate of 1.43‰,which was an occasional adverse reaction(incidence rate 1‰~1%).One new ADR showed conjunctival hemorrhage.There were 42 ADR cases in general.The adverse reactions were mainly pruritus,rash,and headache,involving 8 different systemic injuries throughout the body.There was no serious ADR.ADR mostly occured within 30 minutes of the day of medication.Analysis of influencing factors of adverse reactions suggests that the age group is over 65,with a history of allergies,high concentration,and should pay attention to the occurrence of adverse reactions when combined medication is used.Conclusion:Centralized monitoring in safety hospitals is an effective way to obtain the incidence of adverse reactions of traditional Chinese medicine injections.The safety of YAX injection is good.