“中药注射剂安全信息库”药物警戒模型的效果探究

Exploration of Constructing Drug Alert Model based on the Safety Information Database of Chinese Medicine Injection

目的:探究基于"中药注射剂安全信息库"构建药物警戒模型的效果。方法:选择数据库管理系统ACESS为数据库平台,通过收集资料信息,组建药物警戒小组,分别建立"中药注射剂不良反应个案报告数据库"、"中药注射剂不良反应群案报告数据库"、"中药注射剂组方药物基本信息库"和"中药注射剂配伍禁忌信息库的表和窗体"进而应用宏命令和窗体控件等在ACCESS中进行总数据库平台的集成。建立关于中药注射剂的药物警戒系统模型。通过分析住院医嘱以及门诊处方中的中药注射剂的适应证,重复给药,注意事项,联合用药,用法、用量,DDDs(defined daily dose),用药天数、药物利用指数(drug utilization index,DUI)、药物不良事件(adverse drug event,ADE)、ADR/ADE等做出反应信号提示,药物警戒干预小组做出警告,提醒更改医嘱,以及限制处方等方式进行干预。结果:干预后,中药注射剂在适应证,重复给药,注意事项,联合用药,用法、用量不合理的情况比例明显下降(P<0.05),DDDs、用药天数、DUI、ADE明显减少(P<0.05),ADR/ADE则升高。结论:实行中药注射剂警戒体系后,其药物不良反应的发生率得到显著降低,具有实践意义,值得临床推广。

Objective： To explore the effect of constructing the drug alert model based on the safety information database of Chinese medicine injection. Methods： Choosed database management system ACESS,collected information,built pharmacovigilance group,established the database about case report of adverse reaction and basic information of prescription,and incompatibility information of traditional Chinese medicine injection,integrated the master database platform in ACCESS. A pharmacovigilance system model was established. The Chinese medicine injection indications,repeated administration,matters needing attention,combined medication,usage,dosage,DDDs,DUI,ADE,duration of medication,ADR / ADE of the hospital＇s medical advice and outpatient prescriptions using traditional Chinese medicine injections were analyzed,a response signal warning to change doctor＇s advice,restricted prescription were done,the efficacy of this system was evaluated. Results： Afer intervention,the application of traditional Chinese medicine injection,repeated administration,attention to matters,the combination of drugs,the use of unreasonable dosage decreased（ P〈0. 05）,DDDs,ADE,DUI significantly decreased（ P〈0. 05）,ADR / ADE increased. Conclusion： The incidence rate of ADR decleased after constructing drug alert model.