Review on Cases and Literature of Flurbiprofen (Axetil)-induced Liver Damage

Abstract

Abstract: Objective To evaluate the association between flurbiprofen axetil and liver damage in clinical use.Methods Taking flurbiprofen (axetil) as subject terms, and adverse drug reactions, hepatotoxicity, hepatic damage, transaminases and hyperbilirubin as search term, the authors collected literatures from CNKI, WANFANG Medical Database, VIP Database, Pubmed, Medline and Cochrane CENTRAL Database published at home and abroad from January 1980 to November 2017. The literatures were read and screened for the ADR case reports and drug safety research reports into the study. Data record sheets was designed and the basic information, method feature and intervention were picked up and recorded. Using descriptive research method, the authors evaluated the probability, extent and type of liver damage caused by flurbiprofen (axetil).Results There were 3 randomized trials studies, 1 prescription statistic study, 1 case statistic study and 3 individual case data studies in 8 papers screened. By analyzing 1 210 patients in 3 randomized trials studies, the authors found that about 1% of patients have abnormal liver function. Then they concluded that flurbiprofen (axetil)-induced liver damage was not an uncommon adverse effect. 6 literatures recorded abnormal indicators of liver function without the changes of the bilirubin index. 5 of them indicated abnormal transaminase index and 2 of them indicated abnormal alkaline phosphatase index. The degree of liver damage is judged to be mild and abnormal transaminase to be the main type of liver injury.Conclusion The authors think that flurbiprofen (axetil)-induced liver damage is a common adverse effect and the degree of injury is mainly mild and abnormal transaminase is judged as the main type of liver injury. Considering the limited number and poor quality of current literatures, the relationship between flurbiprofen (axetil) and liver damage needs further study with more clinical statistical analysis in the authors' hospitals.

Key words: flurbiprofen (axetil), adverse reaction, drug induced liver damage(DILD), systematic review

CLC Number:

R994.11

LIU Hao,GUO Dai-hong, SONG Yan-dong,CHAI Dong,MA Liang. Review on Cases and Literature of Flurbiprofen (Axetil)-induced Liver Damage[J]. Chinese Journal of Pharmacovigilance, 2018, 15(5): 291-295.

References

[1] 徐洁, 宋玲, 陆军, 等. 氟比洛芬酯脂微球在大鼠和比格犬体内的药动学及组织分布和排泄研究[J]. 中国临床药理学与治疗学, 2015, 20(12): 1373-1377.
[2] 李健和, 胡焰, 曹俊华, 等. 非甾体抗炎药物注射制剂的开发与临床应用[J]. 中国新药与临床杂志, 2013, 32(3): 167-176.
[3] 吴燕, 李冬梅, 徐超斗, 等. 氟比洛芬酯脂微球注射液的制备及其质量评价[J]. 中国药学杂志, 2013, 48(21): 1847-1851.
[4] Mizushima Y. Lipid microspheres (lipid emulsions) as a drug carrier-An overview[M]. Advanced Drug Delivery Reviews, 1996: 113-115.
[5] 北京泰德制药股份有限公司.（凯纷）氟比洛芬酯注射液说明书[EB/OL]. [2017-12-10]. http://www.tidepharm.com/_d276214985. htm.
[6] 倪晓 , 钟晗, 刘晓琰. 氟比洛芬酯注射液致癫痫发作1例[J]. 中国药物警戒, 2012, 9(7) : 443.
[7] Ohmuka O. Lipo-NSAID preparation[J]. Advanced Drug Delivery Reviews, 1996, 20(2): 203-207.
[8] 于乐成, 茅益民, 陈成伟. 药物性肝损伤诊治指南[J]. 临床肝胆病杂志, 2015, 31(11): 1752-1769.
[9] Moher D, Jadad A R, Tugwell P. Assessing the quality of randomized controlled trials. Current issues and future directions [J]. Int J Technol Assess Health Care, 1996, 12(2): 195-208.
[10] 陈集志，李刚，徐江红，等. 住院患者应用氟比洛芬酯注射液回顾性分析[J]. 中国药师, 2012, 15(4): 542-544.
[11] Littlewood T, Hunter A, Beck P, et al. Treatment of hypercalcaemia in sarcoidosis with flurbiprofen[J]. BRITISH MEDICAL JOURNAL, 1983, 287(10): 2.
[12] Dag M S, Aydinli M, Ozturk Z A, et al. Drug- and herb-induced liver injury: A case series from a single center[J]. The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology, 2014, 25(1): 41-45.
[13] 刘风群. 氟比洛芬与双氯芬酸治疗膝关节炎的比较[J]. 国外医学·药学分册, 1991,18 (4): 245-246.
[14] 金新天, 陈文庆, 刘刚. 氟比洛芬酯脂微球注射液对老年癌痛镇痛作用的临床分析[J]. 中国实用医学, 2011, 6(8): 55-57.
[15] 西娜, 赵冠人. 氟比洛芬酯致急性肝损伤1例[J]. 解放军药学学报, 2017, 33(3): 297.
[16] 祁峰，张婷，吴玲玲. 复方骨肽注射液、氟比洛芬酯注射液致不良反应1例[J]. 中国药师, 2014, 17(7): 1202-1203.
[17] Faich G A, Castle W, Bankowski Z. International reporting on adverse drug reactions: the CIOMS project. CIOMS ADR Working Group[J]. Int J Clin Pharmacol Ther Toxicol, 1990, 28(4): 133-138.
[18] Caille G, Du Souich P, Vezina M, et al. Pharmacokinetic interaction between flurbiprofen and antacids in healthy volunteers[J]. Biopharmaceutics & Drug Disposition, 1989, 10(6): 607-615.
[19] Takada M, Fukusaki M, Terao Y, et al. Postoperative analgesic effect of preoperative intravenous flurbiprofen in arthroscopic rotator cuff repair[J]. Jounal of Anesthesic, 2009, 23(4): 500-503.
[20] Michiyoshi H, Yoshiyuki N, Hiromichi K, et al. Significance of Prostaglandin E1 Administration on Hepatic Hemodynamics during Cirrhotic Liver Resection[J]. The Japanese Society of Gastroente-rological Surgery, 1994, 27(5): 1021-1027.
[21] Padda M S, Sanchez M, Akhtar A J, et al. Drug-induced cholestasis[J]. Hepatology, 2011, 53(4): 1377-1387.
[22] Alfirevic A, Gonzalez-Galarza F, Bell C, et al. In silico analysis of HLA associations with drug-induced liver injury: use of a HLA-genotyped DNA archive from healthy volunteers[J]. Genome Med, 2012, 4(6): 51.