116097例氟比洛芬酯用药人群的急性肾损伤自动监测研究及危险因素分析

doi:10.19803/j.1672-8629.20210741

摘要/Abstract

摘要： 目的了解住院人群中氟比洛芬酯相关急性肾损伤的发生率、临床特征和危险因素。方法依托医疗机构药物不良事件主动监测与智能评估警示系统（ADE-ASAS）,回顾性监测解放军总医院2010年12月1日至2020年11月30日所有使用氟比洛芬酯的住院患者,并进行病例对照研究,分析氟比洛芬酯所致急性肾损伤的发生率、临床特征和危险因素。结果 116 097例使用氟比洛芬酯的住院患者中,急性肾损伤阳性病例815例,发生率0.70%。因果关联性评价结果以可能最多见,692例（84.91%）。阳性病例的严重程度分期以1期为主,449例（55.00%）;转归结果主要是好转,556例（68.22%）;住院科室以肝胆外科为主,575例（70.55%）。合并贫血（OR=2.30;95%CI：1.80~2.94）、较低基线肾小球滤过率（OR=1.01;95%CI：1.01~1.02）、联用利尿剂（OR=3.80;95%CI：3.01~4.81）发生急性肾损伤的风险较高。结论氟比洛芬酯相关急性肾损伤的发生率为偶见;对合并贫血、较低基线肾小球滤过率以及联用利尿剂的患者,临床应用该药时应注意监测。

关键词: 氟比洛芬酯, 急性肾损伤, 自动监测, 危险因素, 真实世界研究

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

中图分类号:

R994.1

王嘉熙, 郭代红, 张博, 李伯妍, 郭海丽. 116097例氟比洛芬酯用药人群的急性肾损伤自动监测研究及危险因素分析[J]. 中国药物警戒, 2023, 20(2): 201-205.

WANG Jiaxi, GUO Daihong, ZHANG Bo, Li Boyan, GUO Haili. Automatic monitoring and risk factors of acute kidney injury in 116097 dosing cases of flurbiprofen axetil[J]. Chinese Journal of Pharmacovigilance, 2023, 20(2): 201-205.

参考文献

[1] LIU H, SONG YD, ZHAO SY, et al.The automatic surveillance study of flurbiprofen axetil-induced liver injury and its related risk factors[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2018, 15(6): 344-347.
[2] WANG K, LUO J, ZHENG LM, et al.Preoperative flurbiprofen axetil administration for acute postoperative pain: a meta-analysis of randomized controlled trials[J]. J Anesth, 2017, 31(6): 852-860.
[3] COLOME NE, SOLANS R, ESPINACH J, et al.Renal papillary necrosis induced by flurbiprofen[J]. DICP, 1991, 25(7-8): 870-871.
[4] KAUFHOLD J, WILKOWSKI M, MCCABE K.Flurbiprofen-associated acute tubulointerstitial nephritis[J]. Am J Nephrol, 1991, 11(2): 144-146.
[5] YU CX, GUO DH, YAO C, et al.Clinical characteristics of hospitalized patients with drug-induced acute kidney injury and associated risk factors: a case-control study[J]. Biomed Res Int, 2020(11): 1-8.
[6] CHEN C, GUO DH, XIE WG, et al.Development of alarming system to actively monitor and assess the adverse drug events in hospitalized patients[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2013, 10(7): 411-414, 418.
[7] CHEN C, JIA WP, GUO DH, et al.Development of a computer-assisted adverse drug events alarm and assessment system for hospital inpatients in China[J]. Ther Innov Regul Sci, 2020, 54(1): 32-41.
[8] OKUSA MD, DAVENPORT A.Reading between the (guide) lines-the KDIGO practice guideline on acute kidney injury in the individual patient[J]. Kidney Int, 2014, 85(1): 39-48.
[9] WU Y, ZHENG XY.Adverse drug reaction reporting and monitoring management measures[J]. Chinese Pharmaceutical Affairs(中国药事), 2004, 23(4): 203-205.
[10] LEVERY AS, INKER LA, CORESH J.GFR estimation: from physiology to public health[J]. Am J Kidney Dis, 2014, 63(5): 820-834.
[11] RODEN M.Diabetes mellitus - definition, klassifikation und diagnose[J]. Wien Klin Wochenschr, 2012, 124(2 Suppl): 1-3.
[12] JONES NR, MCCORMACK T, CONSTANTI M, et al.Diagnosis and management of hypertension in adults: NICE guideline update 2019[J]. Br J Gen Pract, 2020, 70(691): 90-91.
[13] SHEN CX, GE JB.Epidemic of cardiovascular disease in China: current perspective and prospects for the future[J]. Circulation, 2018, 138(4): 342-344.
[14] NUTRITIONAL ANAEMIAS.Report of a WHO scientific group[J]. World Health Organ Tech Rep Ser, 1968, 405: 5-37.
[15] ZHANG KY, JU DX, GONG DH.New understanding of the stages of acute kidney injury[J]. Chinese Journal of Blood Purification(中国血液净化), 2011, 10(7): 389-392.
[16] DREISCHULTE T, MORALES DR, BELL S, et al.Combined use of nonsteroidal anti-inflammatory drugs with diuretics and/or renin-angiotensin system inhibitors in the community increases the risk of acute kidney injury[J]. Kidney Int, 2015, 88(2): 396-403.
[17] MISURAC JM, KNODERER CA, LEISER JD, et al.Nonsteroidal anti-inflammatory drugs are an important cause of acute kidney injury in children[J]. J Pediatr, 2013, 162(6): 1153-1159.
[18] QIU CX, YANG CP, JING HT.Research progress in mechanisms of drug-induced kidney injury[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(11): 688-694, 702.
[19] MUSU M, FINCO G, ANTONUCCI R, et al.Acute nephrotoxicity of NSAID from the fetus to the adult[J]. Eur Rev Med Pharmacol Sci, 2011, 15(12) :1461-1472.
[20] WINKELMAYER WC, WAIKAR SS, MOGUN H, et al.Nonselective and cyclooxygenase-2-selective NSAIDs and acute kidney injury[J]. Am J Med, 2008, 121(12): 1092-1098.
[21] WANG D, YANG SK, ZHAO MX, et al.Low dose of flurbiprofen axetil decrease the rate of acute kidney injury after operation: a retrospective clinical data analysis of 9915 cases[J]. BMC Nephrol, 2020, 21(1): 52.
[22] JIA XM, LAN LQ, TANG LG.Clinical effect of flurbiprofen axetil injection on preemptive and postoperative analgesia in orthopedic surgery patients[J]. The Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2016, 32(2): 150-152.
[23] KHAN S, LOI V, ROSNER MH.Drug-induced kidney injury in the elderly[J]. Drugs Aging, 2017, 34(10): 729-741.
[24] VAN DER MOLEN AJ, REIMER P, DEKKERS IA, et al. Post-contrast acute kidney injury - Part 1: Definition, clinical features, incidence, role of contrast medium and risk factors : Recommendations for updated ESUR Contrast Medium Safety Committee guidelines[J]. Eur Radiol, 2018, 28(7): 2845-2855.
[25] BREZIS M, ROSEN S.Hypoxia of the renal medulla: its implications for disease[J]. N Engl J Med, 1995, 332(10): 647-655.
[26] HAN SS, BAEK SH, AHN SY, et al.Anemia is a risk factor for acute kidney injury and long-term mortality in critically ill patients[J]. Tohoku J Exp Med, 2015, 237(4): 287-295.
[27] CUI R, LI FD, SHAO J, et al.Postoperative anemia is a risk factor for acute kidney injury after open aorta and vena cava surgeries[J]. PLoS One, 2020, 15(10): e0240243.
[28] BAGSHAW SM, GEORGE C, NOEL GIBNEY RT, et al.A multicenter evaluation of early acute kidney injury in critically ill trauma patients[J]. Ren Fail, 2008, 30(6): 581-589.
[29] SUN YB, LIU BC, ZOU Y, et al.Risk factors of acute kidney injury after acute myocardial infarction[J]. Ren Fail, 2016, 38(9): 1353-1358.
[30] LOBOZ KK, SHENFIELD GM.Drug combinations and impaired renal function-the‘triple whammy’[J]. Br J Clin Pharmacol, 2005, 59(2): 239-243.
[31] FENG BH, WU HC.Research progress of diuretic-induced renal damage[J]. Chinese Journal of Integrated Traditional and Western Nephrology(中国中西医结合肾病杂志), 2014, 15(2): 171-173.