马来酸桂哌齐特用药患者11665例的血液系统药品不良反应自动监测研究  

Automatic monitoring research on hematological adrs induced by cinepazide maleate in 11665 patients

作　　者：郭代红[1] 胡鹏洲 王啸宇[1] 刘佳 夏玉坤 马亮[1] 范琦[2] 田小燕[2] 

机构地区：[1]解放军总医院药品供应中心,北京100853 [2]重庆医科大学药学院,重庆401331 [3]国家食药监管总局药品评价中心北京100045

出　　处：《中国临床药理学杂志》2017年第15期1484-1487,共4页The Chinese Journal of Clinical Pharmacology

基　　金：全军后勤科研重点基金资助项目(BWS14R039);国家药品评价中心委托专项(马来酸桂哌齐特注射液的安全性研究)基金资助项目

摘　　要：目的借助自动监测系统高效获取大样本桂哌齐特用药人群相关的血细胞减少发生率,提供临床精准的药物风险数据。方法采用回顾性研究方法对2014-08-01—2016-07-31我院医院信息管理系统历史库中使用过320 mg/10 m L和80 mg/2 m L桂哌齐特的所有住院患者病案记录进行自动监测,人工逐一甄别系统报警的疑似血小板减少、血红蛋白减少、白细胞减少病例,并进行统计分析。结果在11665例用药人群中,血小板、血红蛋白、白细胞减少的发生率分别为0.12%,0.34%和0.20%,总发生率0.66%(无重合病例);有17例患者出现粒细胞减少但未达到粒细胞缺乏标准。血小板减少和贫血多发生在用药5 d前后,而白细胞减少多发生在用药接近10 d。感染是发生该药引起血细胞减少的危险因素。结论桂哌齐特相关血液系统药品不良反应(ADR)的发生率均属偶见。老年伴感染且联用多种药物的桂哌齐特用药患者,应个体化减量并重点观察,以及时发现ADR并规避风险。自动监测系统对接HIS历史数据库,有助于开展更多品种的大样本安全性监测,并高效获取准确ADR发生率。Objective To provide reliable drugs security information for clinic,we acquired incidences of hematological adverse drug reactions（ ADRs） induced by cinepazide maleate among a large population by automatic monitoring system. Methods Automatic monitoring was implemented on all inpatients who received cinepazide in hospital information system retrospectively,including two specifications of 80 mg/2 m L and320 mg/10 m L,from August 1st,2014 to June 31 th,2016. Then suspected cases submitted by system were manually reviewed. Results A total of 11665 patients were monitored. The incidences of thrombocytopenia,anemia and leucopenia were 0. 12%,0. 34% and 0. 2% respectively,and the incidence of hematological ADRs was 0. 66%（ no patients with two or more ADRs）. 17 patients had granulocytopenia,but they were under the diagnostic standard of agranulocytosis. Thrombocytopenia and anemia usually occurred after 5 days,while leucopenia occurred after nearly 10 days. Infection was one of risk factors causing hematological ADRs. Conclusion The incidences of hematological ADRs induced by cinepazide were from 0. 1% to 1%. When prescribing cinepazide forinfective old patients with combined medications,doctors should reduce the routine dose and pay more attention to patients to detect ADR and avoid bad outcomes timely. Data in hospital information system were analyzed through automatic monitoring system,which is helpful to implement safety monitoring on more drugs in a large population and acquire accurate incidences of ADRs efficiently.

关 键 词：桂哌齐特注射液 药品不良反应 自动监测 白细胞减少 血小板减少 血红蛋白减少 

分 类 号：R972[医药卫生—药品]