11665例次马来酸桂哌齐特用药人群的肝肾损害自动监测研究  

Automatic surveillance for cinepazide maleate related liver injury and kidney injury in 11665 patients

作　　者：胡鹏洲 王啸宇[1] 郭代红[1] 马亮[1] 范琦[2] 刘佳 夏玉坤 田小燕[2] HU Peng-zhou;WANG Xiao-yu;GUO Dai-hong;MA Liang;FAN Qi;LIU Jia;XIA Yu-kun;TIAN Xiao-yan(Department of Pharmaceutical Care, PLA General Hospital, Beijing 100853, China;Center for Reevaluation, China Food and Drug Administration, Beijing 100045, China;Chongqing Medical University, Chongqing 401331, China)

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]国家食品药品监管总局药品评价中心,北京100045

出　　处：《中国药物应用与监测》2017年第2期99-101,106,共4页Chinese Journal of Drug Application and Monitoring

基　　金：2014年全军后勤科研重点项目(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)

摘　　要：目的:获取大样本量马来酸桂哌齐特注射液用药人群的药源性肝肾损害发生率。方法:利用自行研发的专项软件回顾性提取2014年8月1日–2016年7月31日期间我院住院患者中所有使用桂哌齐特(320 mg/10 mL,80 mg/2 mL两种规格)者信息进行自动监测,并对系统报警疑似肝肾损害的病例进行逐一甄选。结果:共计11 665例次用药患者中,桂哌齐特相关性肝肾损害发生率分别为0.87%、1.45%,平均年龄分别为(63.0±14.3)岁、(72.0±14.7)岁,发生肝损害的患者用药后ALT最高均值为(190.0±102.5)U·L^(-1),男性明显多于女性;发生肾损害患者用药后SCr升幅均值(41.0±14.1)μmol·L^(-1),肾损害患者平均年龄明显大于用药人群平均年龄;所有ADR病例均自行恢复正常或在临床干预后恢复正常;两种不同规格马来酸桂哌齐特注射液在用药人群间ADR发生率无显著统计学差异。结论:应用专项软件直接对接HIS系统,实施ADR自动监测,数据资源丰富,结果可靠且成本低效率高;桂哌齐特相关肝肾损害发生率分别在偶见、常见范围;临床在使用桂哌齐特时,对老年、基础情况差的患者斟酌减量,有助于减少药源性肝肾损害的发生。Objective:To obtain the incidence of cinepazide maleate related liver injury and kidney injury by means of a large sample study.Methods:A self-developed specific system was used to automatic surveillance for the hospitalized patients in our hospital of PLA who received cinepazide maleate(two specifications,320mg/10mL&80mg/2mL)between August1,2014and July31,2016,and suspected cases submitted by system were evaluated by professionals.Results:A total of11665patients included and the incidence of cinepazide maleate-related liver injury and kidney injury were0.87%and1.45%respectively,the average age were(63.0±14.3)years old and(72.0±14.7)years old respectively,the level of ALT was rising on(190.0±102.5)U·L-1by an average in liver injury patients,the number of male liver injure patients was more than that of female significantly.The level of SCr rose by an average of(41.0±14.1)μmol·L-1in kidney injury patients,and their average age was greater than that of general drug used population obviously.All the positive cases had returned to normal after drug withdrawal or self-healing.Dose difference had no significant effect on the occurrence of ADR.Conclusion:By docking with the HIS system,our specific system could obtain rich ata to complete automatic surveillance efficiently and provide reliable results.The cinepazide maleate related liver injury happened ccasionally and kidney injury happened commonly.In the course of clinic application,the liver injury and kidney injury caused by inepazide can be prevented effectively by reducing the dose in the patients of old age and poor conditions.

关 键 词：马来酸桂哌齐特 药品不良反应 自动监测 肝损害 肾损害 

分 类 号：R575[医药卫生—消化系统]