摘要
目的:通过对注射用头孢哌酮/舒巴坦不良反应检测,挖掘和评价其药品不良反应(ADR)信号,为临床合理用药提供参考。方法:采用报告比值比法(ROR)对烟台市ADR监测中心2015年1月1日～2017年12月31日所报告的数据进行ADR信号挖掘,ROR 95%置信区间(CI)下限> 1提示出现警戒信号。结果:提取数据库中38 324份ADR报告信息,排除重复和联合用药报告后纳入分析的有31 954份,其中以头孢哌酮/舒巴坦为怀疑药物的ADR报告392份。392份报告中共有ADR 518例次(1份患者报告中可能含有多个ADR),其中排名第一的是皮疹,有163例次,其次是瘙痒,有122例次。经ROR法检测出来的ADR信号共10个,其中3个说明书中没有提及,提示为高风险信号。结论:头孢哌酮/舒巴坦相关性皮疹和瘙痒值得重点关注,对自发呈报系统数据库进行ADR信号的检测和分析,能为临床用药提供参考依据。
Objective: Through the cefoperazone sodium/sulbactam sodium for injection,the adverse drug reaction( ADR) signal was excavated and evaluated,which provided a reference for clinical rational drug use. Methods: Using the reported odds ratio method( ROR) to conduct adverse reaction signal mining on the data reported by the Yantai ADR Monitoring Center from January 1 st,2015 to December 31 st,2017. The lower limit of ROR 95% confidence interval( CI) > 1 indicates an alarm signal. Results: A total of 38 324 ADR report information were extracted from the database,and 31 954 were excluded from the analysis after repeated and concomitant drug reports. 518 adverse reactions in 392 reports were suspected by cefoperazone sodium/sulbactam sodium to induce( one patient’s report may contain multiple adverse reactions),the first of which was rash,163 cases,followed by itching,122 cases. A total of 10 adverse reaction signals were detected by ROR method,among which 3 were not mentioned in the specification,indicating high risk signals. Conclusion: Cefoperazone sodium/sulbactam sodium-related rash and itching were worthy of attention. The detection and analysis of adverse reaction signals in the spontaneous reporting system database could provide a reference for clinical drug use.
作者
李硕硕
丁月霞
尹爱群
刘信宇
郭晨煜
周芙蓉
唐启令
Li Shuoshuo;Ding Yuexia;Yin Aiqun;Liu Xinyu;Guo Chenyu;Zhou Furong;Tang Qiling(School of Ph.armaetection,Yantai University,Yantai 264003,Shandong,China;Department of Pharrmacy, Yantai Yuhuangding Hospital;Yantai Drug Adverse Reaction Monitoring Center)
出处
《药物流行病学杂志》
CAS
2018年第12期815-818,共4页
Chinese Journal of Pharmacoepidemiology
关键词
头孢哌酮/舒巴坦
药品不良反应
信号挖掘
报告比值比
Cefoperazone soudium/sulbactam sodium
Adverse drug reaction
Signal mining
Reported odds ratio
