Abstract: Objective To find out about the incidence, clinical characteristics and risk factors of flurbiprofen axetil-related acute kidney injury among inpatients. Methods Based on the Adverse Drug Events Active Surveillance and Assessment System (ADE-ASAS) in medical institutions, all the hospitalized patients using flurbiprofen axetil in Chinese PLA General Hospital between December 1, 2010 and November 30, 2020 were retrospectively monitored and a case-control study was conducted to analyze the incidence, clinical characteristics and risk factors of acute kidney injury due to flurbiprofen axetil. Results Among the 116 097 hospitalized patients who used flurbiprofen axetil, there were 815 positive cases of acute kidney injury, with an incidence of 0.70%. The results of the causal correlation evaluation were predominantly “probable”, with 692 cases (84.91%). The severity staging of positive cases was predominantly stage 1, with 449 cases (55.00%). The outcome of regression was mostly improvement, with 556 cases (68.22%). The departments involved were predominantly those of hepatobiliary surgery, with 575 cases (70.55%). Combined anemia (OR=2.30; 95%CI: 1.80~2.94), lower baseline eGFR (OR=1.01; 95%CI: 1.01~1.02), and co-administration of diuretics (OR=3.80; 95%CI: 3.01~4.81) were associated with a higher risk of acute kidney injury. Conclusion The incidence of flurbiprofen axetil-associated acute kidney injury is episodic. Clinical use of the drug should be monitored in patients with combined anemia, lower baseline eGFR, and co-administration of diuretics.

Key words: flurbiprofen axetil, acute kidney injury, automatic monitoring, risk factors, real world research