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白蛋白结合型紫杉醇相关药品不良反应的自动监测研究

Study on Adverse Drug Reactions Related to Albumin bound Paclitaxel by Automatic Surveillance

DOI：

中文关键词: 白蛋白结合型紫杉醇自动监测血细胞减少肝功能异常急性肾损伤药品不良反应

英文关键词:Albumin bound paclitaxel Automatic surveillance Hypocytosis Hepatic dysfunction Acute kidney injury Adverse drug reaction

基金项目:2014年全军后勤科研重点项目（编号：BWS14R039）

作者	单位
寇炜^① 郭代红^① 王伟兰^① 贾王平^① 王啸宇^① 胡鹏洲^①	①解放军总医院药品供应中心（北京 100853）

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中文摘要:

摘要目的：研究住院患者使用白蛋白结合型紫杉醇致相关药品不良反应（ADR）的发生率及相关因素。方法：采用回顾性分析，利用“医疗机构ADE主动监测与智能评估警示系统”，筛选我院2015年10月1日～2016年9月30日使用白蛋白结合型紫杉醇化疗的住院患者作为研究对象，研究其相关ADR发生率，并对血液系统ADR相关因素进行分析。结果：系统共监测病例1 667 例，白细胞减少、中性粒细胞减少、血小板减少、贫血、肝功能异常及急性肾损伤的阳性报警率分别为94.24%，98.67%，91.78%，83.61%，70.33%和15.38%。血液系统ADR的总体发生率为39.06%，其中白细胞减少、中性粒细胞减少、血小板减少及贫血的发生率分别为29.26%，18.55%，7.39%和13.57%；肝功能异常发生率为14.53%；急性肾损伤发生率为0.38%。研究显示白蛋白结合型紫杉醇致血液系统ADR组与未致ADR组比较，在患者性别、年龄及住院次数方面差异无统计学意义（P>0.05），但ADR组患者体重指数更低（P<0.05）。结论：借助专项系统能够高效、精准的对目标药物实行自动监测，警示临床用药方案，减少ADR发生风险。白蛋白结合型紫杉醇在临床使用过程中，要密切监测血液学指标及肝肾功能，做好防范。

英文摘要:

ABSTRACT Objective:To study the incidence and related factors of adverse drug reactions caused by albumin bound paclitaxel in hospitalized patients. Methods:The research objects were screened out by adverse drug events’ active surveillance and assessment system developed by our hospital. The collected data of the hospitalized patients in our hospital who received chemotherapy of albumin bound paclitaxel between October 1, 2015 and September 30, 2016 were analyzed retrospective. The incidence of adverse drug reactions caused by albumin bound paclitaxel and the related factors were investigated.Results: A total of 1 667 cases were automatically monitored. Positive alarm rate of monitoring modules related to leukopenia, neutropenia, thrombocytopenia, anemia, hepatic dysfunction and acute kidney injury were 94.24%, 98.67%,91.78%, 83.61%, 70.33% and 15.38% respectively. The overall incidence of hematologic ADR was 39.06%. Incidence of leukopenia, neutropenia, thrombocytopenia, anemia, hepatic dysfunction and acute kidney injury were 29.26%,18.55%,7.39%,13.57%,14.53% and 0.38% respectively. There was no significant difference in occurrence of hematologic ADR caused by albumin bound paclitaxel among the gender, age and frequencies of hospitalization (P>0.05).The occurrence was different in the BMI(P<0.05) and Group ADR was lower in the BMI. Conclusion:By using the system, Pharmacists could efficiently and accurately implement automatic surveillance of target drugs and make a guidance for rational drug use and reduce the risk of ADR. Indexes of hematological system，hepatic and renal function should be closely monitored in the course of clinical drug use to prevent the occurrence of adverse reactions.

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