摘要
目的:挖掘和评价抗MRSA抗生素性别差异性药品不良反应信号(ADR),为不同性别患者临床合理用药提供参考。方法:调取美国FDA不良事件报告系统(FAERS)数据库2004年1月1日-2016年12月31日接收的万古霉素、利奈唑胺、达托霉素、替考拉宁药品不良事件(ADE)报告,采用报告比值比(ROR)数据挖掘方法对前述药品进行性别差异性ADR信号挖掘。结果:提取FAERS数据库信息得到ADE报告万古霉素3827例、利奈唑胺6 372例、达托霉素3 454例、替考拉宁1 413例,经ROR法检测,分别得到性别差异性ADR信号3,11,6,9个。统计学分析发现,女性患者各药品ADE上报数均小于男性患者,但女性ADR信号数量及强度均高于男性。对于女性患者,万古霉素、利奈唑胺、替考拉宁易发重症药疹及其相关ADR,如万古霉素(ROR=3.12;P=2.21×10_(-17))与利奈唑胺(ROR=2.62;P=8.28×10_(-5))诱发的药物超敏反应,替考拉宁诱发的毒性表皮坏死松解症(ROR=5.21;P=1.46×10(-6))、史-约综合征(ROR=4.54;P=6.80×10^(-6))等。对于男性患者,万古霉素未见ADR信号,利奈唑胺与达托霉素出现肾功能受损信号。结论:万古霉素、利奈唑胺、达托霉素、替考拉宁存在性别差异性ADR信号,临床医务人员应提高对抗MRSA抗生素不良反应性别差异性的认识,避免发生严重不良反应。
OBJECTIVE To excavate and evaluate the adverse drug reaction（ADR）signals of sex differences induced by anti-methicillin-resistant Staphylococcus aureus（anti-MRSA）antibiotics,and provide a reference for its clinical medication for different genders.METHODS Reporting odd ratio（ROR）data mining algorithm was used to investigate signals of sex differences of vancomycin（VCM）,linezolid（LZD）,daptomycin（DAP）and teicoplanin（TEIC）from FAERS submitted to FDA from2004 to 2016.RESULTS Totally 3 827,6 372,3 454,1 413 adverse drug event reports were found in FAERS database induced by VCM,LZD,DAP and TEIC.After detection by ROR,3,11,6,9 signals related to 10 above mentioned drugs were identified.The statistical analysis found that the ADE report number of female was less than that in male,but the number and strength of signals were greater than those in male.As for female patients,VCM,LZD and TEIC were more frequently associated with severe drug eruptions and its related ADR signals,such as VCM（ROR=3.12;P=2.21×10_（-17））and LZD（ROR=2.62;P=8.28×10_（-5））induced drug hypersensitivity,TEIC induced toxic epidermal necrolysis（ROR=5.21;P=1.46×10_（-6））and StevensJohnson syndrome（ROR=4.54;P=6.80×10_（-6））.As for male,VCM showed no correlated signal while LZD and DAP were related to renal impairment.CONCLUSION VCM,LZD,DAP and TEIC have gender difference in ADR signals.In order to avoid the occurrence of serious adverse reactions,clinicians must be aware of anti-MRSA antibiotics ADR associate with sex difference.
出处
《中国医院药学杂志》
CAS
北大核心
2018年第3期262-265,274,共5页
Chinese Journal of Hospital Pharmacy
基金
重庆市社会民生科技创新专项(编号：cstc2016shmszx130048)
