报告比值比法挖掘富马酸替诺福韦二吡呋酯不良反应信号  

ADR Signals of Tenofovir Disoproxil Fumarate Mined by Reporting Odds Ratio Method

作　　者：王宇[1] 饶友义[1] 郭军[2] 余江平[1] 

机构地区：[1]绵阳市中心医院药剂科,四川绵阳621000 [2]绵阳市中心医院儿科,四川绵阳621000

出　　处：《中国药房》2016年第32期4515-4518,共4页China Pharmacy

摘　　要：目的:通过对富马酸替诺福韦二吡呋酯(TDF)不良反应进行分析及信号挖掘,为临床合理用药提供参考。方法:对美国不良事件报告系统(AERS)2013年第三季度至2014年第二季度收集到的TDF不良反应事件报告进行分析,同时采用报告比值比(ROR)法对信号进行挖掘。结果:TDF的不良反应主要集中于消化系统、肾和泌尿系统、神经系统、皮肤和皮下组织系统、肌肉骨骼和结缔组织等,同时可以影响实验室检查的结果;共挖掘出TDF可疑不良反应危险信号42个,其中6个说明书尚未提及,且其中氨基酸尿不良反应信号强度较强。结论:TDF致消化道功能障碍虽较多,但大多数表现并不严重,其致肾功能损害数量较多,但后果严重;此外,氨基酸尿信号强度较强,且说明书未提及,故值得进一步研究。OBJECTIVE： To provide reference for clinical rational drug use through analyzing ADR of tenofovir disoproxil fumarate （TDF） and mining warning signals. METHODS： The ADR of TDF in Adverse Event Reporting System （AERS） for the United States, from the third quarter of 2013 to the second quarter of 2014, were analyzed. And the warning signals of adverse drug reactions were mined by Reporting Odds Ratio （ROR） method. RESULTS： The ADR of TDF often involved the system of gastrointestinal, renal, urinary, nervous, skin and subcutaneous tissue, musculoskeletal and connective tissue, etc, the drug could also affect laboratory examination. 42 warning signals by TDF were obtained, 6 of which being not mentioned by the instruc- tion. Among all ADR of TDF, the signal intensity of minoaciduria was the highest. CONCLUSIONS ： TDF-induced digestioe tract dysfunction are large in quantities but most of them are not severe; TDF-induced renal function damge are larqe in quantities and severe.

关 键 词：富马酸替诺福韦二吡呋酯 报告比值比法 药品不良反应 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]