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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Issue 1
Jan.  2018
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Signal mining and analysis of the adverse drug reaction of digestive dysfunction caused by the new anti-HCV drug sofosbuvir

DOI: 10.3969/j.issn.1001-5256.2018.01.014
  • Published Date: 2018-01-20
  • Objective To investigate the safety of a new anti-HCV drug, sofosbuvir, through mining the adverse drug reaction ( ADR) signals of digestive dysfunction caused by this drug. Methods The reporting odds ratio ( ROR) was used for mining the ADR signals of digestive dysfunction caused by sofosbuvir from 2014 to the first quarter of 2016 in the American Adverse Event Reporting system, and the distribution of signals among patients with different sexes, ages, and doses was analyzed. The chi-square test was used for comparison of categorical data between groups. Results A total of 17 ADR signals were detected, among which 15 were not included in the package insert.Among these signals, gastric variceal bleeding had the highest ROR value of 58. 41, followed by esophageal variceal bleeding ( 47. 92) , gastric varices ( 20. 02) , esophageal varices ( 17. 60) , and ascites ( 14. 92) , and all ADR signals had low intensity. There was a significant difference in the distribution of these signals between patients with different sexes ( P < 0. 001) , ages ( P = 0. 009) , or doses ( P = 0. 002) .Conclusion Mining and analysis of ADR signals of digestive dysfunction caused by sofosbuvir can provide a reference for a comprehensive and systematic evaluation of the safety of target system.

     

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  • [1]Mc HUTCHISON JG, LAWITZ EJ, SHIFFMAN ML, et al.Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection[J].N Engl J Med, 2009, 361 (6) :580-593.
    [2]WEI X, XIE YM, CHEN L, et al.Antiviral therapy with pegylated interferon alpha-2a plus ribavirin in patients with HCV related cirrhosis and to establish the grading for standard therapy[J].J Clin Hepatol, 2011, 27 (1) :89-92. (in Chinese) 魏欣, 谢玉梅, 陈琳, 等.丙型肝炎肝硬化的“分级”及聚乙二醇干扰素α-2a联合利巴韦林的抗病毒治疗[J].临床肝胆病杂志, 2011, 27 (1) :89-92.
    [3]ZHANG Y, WEI X, JIA ZS, et al.Grading antiviral therapy in HCV-infected cirrhotic patients[J].J Clin Hepatol, 2013, 29 (2) :93-95. (in Chinese) 张颖, 魏欣, 贾战生, 等.丙型肝炎各级肝硬化患者的抗病毒治疗策略[J].临床肝胆病杂志, 2013, 29 (2) :93-95.
    [4]CHEN D, TANG SL.Clinical research advances in the new antiHCV drug sofosbuvir[J].China Pharm, 2015, 16 (26) :2284-2286. (in Chinese) 陈丹, 汤姝岚.抗丙型肝炎病毒药索非布韦的临床研究进展[J].中国药房, 2015, 16 (26) :2284-2286.
    [5]ZHANG J, ZHANG XF, LIU XM, et al.Clinical effect of sofosbuvir combined with ribavirin in treatment of hepatitis C recurrence after liver transplantation:a case report[J].Ogran Transplantation, 2016, 7 (1) :61-63. (in Chinese) 张静, 张胥丰, 刘学民, 等.术后丙型病毒性肝炎复发:附1例报告[J].器官移植, 2016, 7 (1) :61-63.
    [6]SUN DH, YAN XB.Research progress of the related resistance mutations of direct-acting antiviral agents for HCV infection treatment[J/CD].Chin J Exp Clin Infect Dis:Electronic Edition, 2016, 10 (5) :534-540. (in Chinese) 孙丹辉, 颜学兵.抗HCV新型直接抗病毒药物相关耐药位点研究进展[J/CD].中华实验和临床感染病杂志:电子版, 2016, 10 (5) :534-540.
    [7] CHEN EH.Clinical effect of pegylated interferon and ribavirin given alone or in combination with sofosbuvir in treatment of chronic hepatitis C[J].Chin Baby, 2016, 2:74. (in Chinese) 陈恩华.聚乙二醇干扰素利巴韦林单用及联合索非布韦治疗慢性丙型肝炎疗效观察[J].母婴世界, 2016, 2:74.
    [8]PENG Y, WANG CC, TANG L, et al.Signal excavation and evaluation of sitagliptin induced skin ADR after going public[J].China Pharm, 2014, 25 (2) :156-158. (in Chinese) 彭媛, 王程程, 唐利, 等.西格列汀上市后致皮肤不良反应的信号挖掘与评价[J].中国药房, 2014, 25 (2) :156-158.
    [9]PENG Y, WANG CC, TANG L, et al.Mining and evaluation of the safe warning signals induced by sitagliptin in post-marketing experience[J].Chin J Hosp Pharm, 2014, 34 (1) :33-36. (in Chinese) 彭媛, 王程程, 唐利, 等.西格列汀上市后安全警戒信号的挖掘与评价[J].中国医院药学杂志, 2014, 34 (1) :33-36.
    [10]SAKAEDA T, KADOYAMA K, OKUNO Y.Statin-associated muscular and renal adverse events:data mining of the public version of the FDA adverse event reporting system[J].PLoS One, 2011, 6 (12) :e28124.
    [11]WEI ZJ, CHENG NN, HE L, et al.Establishment of quantitative signal detection system on adverse drug reaction spontaneous reporting database of Shanghai[J].Fudan Univ J Med Sci, 2006, 33 (4) :475-490. (in Chinese) 魏志军, 程能能, 何乐, 等.上海市药品不良反应自发呈报数据库定量信号检测系统的建立[J].复旦学报:医学版, 2006, 33 (4) :475-490.
    [12]ZHANG XL, XIA J.A preliminary analysis of safety signals and signal management in pharmacovigilance[J].Chin J Pharmacoepidemiol, 2012, 21 (2) :90-94. (in Chinese) 张晓兰, 夏佳.浅谈药物警戒中的安全信号与信号管理[J].药物流行病学杂志, 2012, 21 (2) :90-94.
    [13]U.S.food and drug odministration.SOVALDI (sofosbuvir) tablets, for oral use[EB/OL]. (2015-08-20) .http://www.ac- cessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf
    [14]FAZEL Y, LAM B, GOLABI P, et al.Safety analysis of sofosbuvir and ledipasvir for treating hepatitis C[J].Expert Opin Drug Saf, 2015, 14 (8) :1317-1326.
    [15]TONG MJ, CHANG PW, HUYNH TT, et al.Adverse events associated with ribavirin in sofosbuvir-based therapies for patients with chronic hepatitis C:a community practice experience[J].J Dig Dis, 2016, 17 (2) :113-121.
    [16]ROTHMAN KJ, LANES S, SACKS ST.The reporting odds ratio and its advantages over the proportional reporting ratio[J].Pharmacoepidemiol Drug Saf, 2004, 13 (8) :519-523.
    [17]Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association.The guideline of prevention and treatment for hepatitis C:a 2015 update[J].J Clin Hepatol, 2015, 31 (12) :1961-1979. (in Chinese) 中华医学会肝病学分会, 中华医学会感染病学分会.丙型肝炎防治指南 (2015年更新版) [J].临床肝胆病杂志, 2015, 31 (12) :1961-1979.
    [18]WANG SJ, QIAN JM.Research progress in drug-induced pancreatitis[J].ADRJ, 2014, 16 (6) :359-361. (in Chinese) 王淑君, 钱家鸣.药源性胰腺炎研究进展[J].药物不良反应杂志, 2014, 16 (6) :359-361.
    [19]SUN JM.Prevention and treatment of drug-induced pancreatitis[J].China Prac Med, 2011, 6 (30) :226-228. (in Chinese) 孙建明.药源性胰腺炎及其防治[J].中国实用医药, 2011, 6 (30) :226-228.
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