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 instruction. 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
Keywords
Tenofovir disoproxil fumarateReporting Odds Ratio methodADRSignals mining