10830例马来酸桂哌齐特关联性药品不良反应报告分析

Analysis for 10830 Cases of Adverse Drug Reactions Caused by Cinepazide Maleate Injection

目的:分析马来酸桂哌齐特注射液药品不良反应(ADR)报告基本情况、患者特征、用药情况、具体表现与转归。方法:对国家药品不良反应监测中心2004年1月~2016年6月收集的马来酸桂哌齐特注射液相关ADR报告进行描述性分析,对ADR报告来源、患者性别及年龄、用药原因、给药途径、合并用药、不良反应表现及分类、白细胞减少/中性粒细胞减少病例、过敏性休克/过敏样反应病例、死亡病例、转归等项目进行统计分析。结果:共收集马来酸桂哌齐特注射液相关ADR报告10 830例,其中严重报告占比4.08%,男女比例1∶1.19,患者平均年龄、日剂量、疗程分别为(61.23±15.41)岁、(250.29±77.15)mg、(3.36±2.68)d。ADR表现主要累及神经系统、皮肤及其附件、消化系统等;相关血液系统损害主要表现为白细胞减少及中性粒细胞减少,占比达96.15%。ADR转归为好转或痊愈的占99.38%。结论:桂哌齐特相关ADR表现严重程度多属轻微,绝大部分预后良好,白细胞减少和中性粒细胞减少仍然是其特征ADR,严重过敏反应不容忽视。

Objective： To analyze the basic situation,patient features,drug use situation,specific expression and results of the adverse drug reactions（ADRs） reports on cinepazide injection. Methods： Performed descriptive analysis of the ADRs reports on cinepazide injection,which had been collected from January 2004 to June 2016 by Center for Drug Reevaluation,CFDA. The ADRs report source,patient gender and age,medication cause,drug delivery route,drug combination,ADR behavior and calssification,leukopenia/neutrophile granulocyte cases,allergic shock/Anaphylactoid reaction cases,death case,prognosis and so on were analyzed staitistically. Results： Among 10 830 cases of ADRs reports,the severe reports account for 4. 08%,the ratio of infected male to female was 1∶1. 19,the average age was（61. 23 ± 15. 41）years old,the average daily dose was（250. 29 ± 77. 15） mg and the average course of treatment was（3. 36 ± 2. 68） days.The ADRs mainly involveed nervous system,skin and its accessory system,digestive system,etc. Among its blood system diseases,the decrease of WBC and NE accounted for 96. 15%. About 99. 38% of the ADRs took a better turn or heals.Conclusion： the ADRs of cinepazide injection was minor and most of the results were acceptable. The ADRs was still characterized by the decrease of WBC and NE and the severe allergic reaction should not be ignored.