Analysis and Suggestions on Risk of Ribavirin in Children

Abstract

Abstract: Objective Through comparatively analyzing the approval, application and instructions of ribavirin at home and abroad, to conduct the risk analysis of domestic children ribavirin clinical use based on the ribavirin's children ADR report data in a certain province, so as to provide suggestions on the modification of instructions, clinical application, regulation and so on. Methods The risk of ribavirin was analyzed by means of comparing ribavirin's approval, application and instructions at home and abroad,and analyzing ribavirin's children ADR reports collected by a certain province from January 2003 to December 2016. Results The approval and application of ribavirin were different significantly between China and abroad, the phenomenons of irrational drug combination and off-label use are common during clinical application in children. Conclusion It is suggested that regulatory authority, manufactures and healthcare providers should pay attention to unapproved indications and dosage form of ribavirin, while revising and improving instruction for more standardized application .

Key words: ribavirin, approval and clinical application, comparison of instructions, risk analysis, children

CLC Number:

R994.11

LI Qing-fang, LIU Huan, ZHANG Dan-dan, YANG Yue, ZHANG Hui-xia, XIA Xu-dong, LIU Chao. Analysis and Suggestions on Risk of Ribavirin in Children[J]. Chinese Journal of Pharmacovigilance, 2018, 15(2): 83-89.

References

[1] FDA. Emergency Investigational New Drug (EIND) Applications for Antiviral Products[EB/OL].(2017-05-01) [2017-05-07]. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrug-indapplication/ucm090039.htm.
[2] Bordigoni P, Carret A S, Venard V, et al.Treatment of adenovirus infections in patients undergoing allogenic hematopoietic stem cell transplantation[J].Clin Infect Dis, 2001, 32(9):1290-1297.
[3] Andrea Riner MPH, Kirk M,Chan-Tack MD & Jeffrey S. Murray MD.Original Research: Intravenous Ribavirin-Review of the FDA's Emergency Investigational New Drug Database (1997-2008) and Literature Review[J].Postgraduate Medicine, 2009, 121(3):5-15.
[4] N J C Snell.Ribavirin-current status of a broad spectrum antiviral agent[J]. Expert Opinion on Pharmacotherapy, 2001, 2(8):1317-1324.
[5] 刘敬先,杜柏林,王丽娜. 浅谈利巴韦林[J]. 黑龙江医药科学,2013,36(5):24-25.
[6] 程小平. 双黄连粉针剂联合利巴韦林治疗小儿病毒性肺炎的疗效分析[J]. 中国医药指南,2012,(12):255-256.
[7] 邓向红,刘迪辉,林茹珠,等. 利巴韦林颗粒剂对小儿病毒性上呼吸道感染的疗效评价[J]. 药学进展,2003,(3):171-173.
[8] 刘兵兵,华丽霞,董艳,等. 喜炎平与利巴韦林治疗小儿手足口病疗效和安全性的系统评价[J]. 中国实验方剂学杂志,2014,(9):231-236.
[9] 姜宏磊,韩秀珍,马沛然,黄磊. 利巴韦林对病毒性心肌炎的疗效及机制的实验研究[J]. 实用儿科临床杂志,2005,(11):71-73.
[10] 余文英. 利巴韦林的研究应用及展望[J]. 亚太传统医药,2010,6(11):175-177.
[11] Chemaly, R.F，Aitken, et al.Aerosolized ribavirin: the most expensive drug for pneumonia[J].Transpl Infect Dis, 2016, 18(4):634-636.
[12] Shook B C, Lin K..Recent Advances in Developing Antiviral Therapies for Respiratory Syncytial Virus.[J].Top Curr Chem (Z), 2017, 375(2):40.
[13] Glue P.The clinical pharmacology of ribavirin. Semin Liver Dis [J].Semin Liver Dis, 1999, 19(1):17-24.
[14] De Franceschi L, Fattovich G, Turrini F, et al.Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection: role of membrane oxidative damage. Hepatology[J].Hepatology, 2000, 31(4):997-1004.
[15] 饶艳辉.利巴韦林致182 例不良反应文献分析[J].中国医院用药评价与分析,2007, 4(25):52-56.
[16] 鲁仲平,刘丽敏.56例利巴韦林注射剂严重不良反应分析[J]. 中国药物滥用防治杂志,2012,(3):179-182.
[17] 赵瑞玲,毛秀娣,张丽锋. 利巴韦林在儿科临床应用的安全性评价[J]. 国际药学研究杂志,2016,(4):615-620.