我院康艾注射液ADR集中监测研究

Centralized monitoring of adverse drug reactions associated with Kang’ai injection in our hospital

目的:研究康艾注射液不良反应的发生率、临床表现,评价临床使用的安全性,为临床合理用药提供参考。方法:采用前瞻性医院集中监测方法,选取我院2015年10月–2019年12月使用康艾注射液的10387例住院患者的用药数据,观察患者的一般信息、临床诊断、用药情况及不良反应/不良事件(ADR/ADE)的发生情况。结果:10387例观察病例中,发生ADR12例,ADR发生率为0.115%,属于偶见不良反应。ADR主要表现为皮疹、瘙痒、水肿、寒战等,未监测到严重ADR。结论:我院康艾注射液不良反应发生率较低,临床使用安全性良好。

Objective:To investigate the incidence and clinical manifestations of adverse drug reactions(ADRs)associated with Kang’ai injection in order to evaluate the safety and provide references for clinical rational use of Kang’ai injection.Methods:Data of a total of 10387 inpatients treated with Kang’ai injection from October 2015 to December 2019 were collected from centralized hospital monitoring system of ADR in our hospital and analyzed in terms of general information,clinical diagnosis,medicines and ADR/adverse drug event(ADE).Results:In 10387 patients,ADRs associated with Kang’ai injection were observed in 12 cases with an incidence of 0.115%,which was the occasional ADR.The clinical manifestations of ADR were rash,itching,edema,trembling,etc.Conclusion:The incidence of ADR associated with Kang’ai injection in our hospital was low,which indicated that the clinical application of Kang’ai injection was relatively safe.