5所医院19487例马来酸桂哌齐特用药人群ADR自动监测与评价

Automatic monitoring and evaluation of cinepazide maleate related ADR in 19487 hospitalized patients of five hospitals

目的:通过实施哨点医院多中心ADR信息化重点品种主动监测研究,探讨药物监测与评价规律和相关因素,深化军队药物警戒工作。方法:经过集中培训,按照统一监测条件,利用"住院患者药品不良事件主动监测与评估警示系统",自动监测2016年1–12月期间5所军队哨点医院19 487例马来酸桂哌齐特用药人群数据,系统报警案例经人工逐例分析后上报汇总并统计分析。结果:马来酸桂哌齐特注射液相关血小板减少、血红蛋白减少、白细胞减少、肝损害、肾损害发生率分别为0.20%、0.37%、0.41%、1.37%、0.82%;总发生率3.17%。未见相关性粒细胞缺乏病例。多中心监测结果能反映各医院的用药习惯和真实人群特点,但总体趋同。结论:基于大样本真实世界研究获得的药物上市后安全性再评价结果更具参考意义;基于专项软件开展多中心药物安全性再评价,数据可靠、便捷高效。桂哌齐特注射液工艺改进后,临床用药较为安全。

Objective:To figure out the rule and relevant factors of drug safety monitoring and assessment,and improvethe military pharmacovigilance practice by conducting multi-center sentinel hospital ADR informationalized active monitoring study.Methods:Under the centralized training and uniform monitoring condition,automatic monitoring were conducted by the active monitoringand assessment of adverse drug events for hospitalized patients system,which covered19487cases used cinepazide in5hospital in Januaryto December2016.The warning cases that were detected by the system were manually evaluated,and then the data was submitted andanalyzed statistically.Results:The incidence of cinepazide maleate related thrombocytopenia,hemoglobin decreased,leukocytopenia,liverdamage and renal damage were0.20%,0.37%,0.41%,1.37%and0.82%,respectively;the total incidence of ADR was3.17%.No relatedagranulocytosis was detected.The miniature of drug utilization custom and population characteristic in different hospitals can be reflectedby the monitoring results of multi-center,but the general trends were similar.Conclusion:The big data that came from real world studieswas more meaningful in drug post-market evaluation.The special software on multi-center drug safety evaluation was reliable and efficient.With the improvement of manufacturing process,the cinepazide is safe in clinical practice.