药源性进行性多灶性白质脑病的风险因素及相关药品风险管理实践

摘要/Abstract

摘要： 目的深入了解药源性进行性多灶性白质脑病的病因及风险因素,实现对风险药物及药源性疾病的有效控制。方法对进行性多灶性白质脑病的病原学基础、发病机制、药物相关性的风险因素、以及相应的风险管理实践进行了分析和梳理。结果 JC病毒感染是发生药源性进行性多灶性白质脑病的病原学基础,免疫功能受损患者是易感人群,长期及多种免疫抑制剂或免疫调节剂使用可增加药源性进行性多灶性白质脑病的风险。结论合理的风险控制措施可有效控制不同风险级别药品进行性多灶性白质脑病的发生风险。我国相关病例报告较少,仍需要加强监测,提高风险控制能力。

关键词: 药源性, 进行性多灶性白质脑病, 药品风险管理

Abstract: Objective To investigate the etiology and risk factors, to control effectively the risk of the drug-induced progressive multifocal leukoencephalopathy (PML). Methods The etiology and pathogenesis of PML, the risk factors of drug-induced PML, and the practice of risk management were analyzed. Results The JC virus infection is etiology base of drug-induced PML, the patients who are immunosuppressed or have malfunction of the immune system are at higher risk of developing PML. Immunosuppressive medications used for long time or combination with immunomodulators could increase the risk of drug-induced PML. Conclusion The reasonable risk managements could control effectively the risk of drug-induced PML. The individual serious case report of drug-induced PML is few now, so we should enhance the abilities of monitoring and drug risk management on drug-induced PML.

Key words: drug induced, progressive multifocal leukoencephalopathy, drug risk management

中图分类号:

R994.11

冯红云, 范燕, 吴桂芝, 董铎. 药源性进行性多灶性白质脑病的风险因素及相关药品风险管理实践[J]. 中国药物警戒, 2016, 13(8): 472-475.

FENG Hong-yun, FAN Yan, WU Gui-zhi, DONG Duo. Research of the Risk Factors and Practice of Drug Risk Management on Drug-induced Progressive Multifocal Leukoencephalopathy[J]. Chinese Journal of Pharmacovigilance, 2016, 13(8): 472-475.

参考文献

[1] Astrom K E, Mancall E L, Richardson E P Jr. Progressive multifocal leukoencephalopathy：a hitherto unrecognized complication of chronic lymphatic leukaemia and Hodgkin’s disease[J]．Brain,1958,81（1）:93-111.
[2] KoralnikI J. Progressive multifocalleukoencephalopathy revisited: has thedisease outgrown its name?[J]. Ann Neurol,2006,60（2）: 162-173.
[3] FDA.FDA Issues Public Health Advisory on Tysabri, a New Drug for MS[EB/OL]. (2005-02-28)[2016-06-15]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108413.htm.
[4] Cavanagh J B, Greenbaum D, Marshall A H, et al. Cerebral demyelination associated with disorders of the reticuloendothelialsystem[J]. Lancet. 1959, 2（7012）:524-529.
[5] Zurheing G, Chou S M. Particles resembling papova viruses in human cerebral demyelinating disease[J]. Science,1965,148（1477）: 1477-1479.
[6] Padgett B L, Walker D L, ZuRhein G M, et al．Cultivation of papova-like virus from human brain with progressive multifocal leucoencephalopathy[J]. Lancet,1971,1（7712）: 1257-1260.
[7] Major E O, Amemiya K, Tomatore C S, et al. Pathogenesis andmolecular biology of progressive multifocal leukoencephalopathy, the J C virus-induced demyelinating disease of the human brain[J]. ClinMicrobiol Rev,1992,5（1）: 49-73.
[8] 蒋荣猛, 黄昌宏, 李兴旺. JC病毒研究进展[J]. 传染病信息, 2010,23（6）: 372-375.
[9] Eash S, Tavares R, Stopa E G, et al. Differential distribution of the JC virus receptor-type sialic acid in normal human tissues[J]. AmJ Pathol,2004,164（2）: 419-428.
[10] Khanna N, Wolbers M, Mueller N J, et a1. J C virus-specific immuneresponses in human immunodefieieney virus type l patients withprogressive multifocal leukoencephalopathy[J]. J Virol, 2009,83（9）: 4404-4411.
[11] Kato A, Kitamura T, Takasaka T, et al. Detection of the archetypalregulatory
region of JC virus from the tonsil tissue of patients withtonsillitis and tonsillar hypertrophy[J]. J Neurovirol,2004,10（4）: 244-249.
[12] Hou J, Seth P, Major E O. J C virus can infect human immune and nervous system progenitor cells: implications for pathogenesis[J]. AdvExp Med Biol,2006,577: 266-273.
[13] Berger J R. Progressive multifocal leukoencephalopathy[J].Handb Clin Neurol,2007,85: 169-183.
[14] 刘磊, 王得新, 王佳伟. 进行性多灶性白质脑病的临床与基础
研究新进展[J]. 中国现代神经疾病杂志,2011,11（5）: 504-512.
[15] Angelini L, Pietrogrande M C,Delle Piane M R, et al. Progressive multifocal leukoencephalopathyin achildwith hyperimmunoglobulin E recurrent infection syndrome and review of the literature.Neuropediatrics,2001,32（5）:250-255.
[16] 国家食品药品监督管理总局药品评价中心. 美国修改吗替麦考酚酯说明书警示白质脑病[EB/OL]. 药物警戒快讯. (2008-07-25)[2016-06-15]. http://www.cdr-adr.org.cn/jjkx_258/ywjjkx/2008/200812/t20081216_1700.html.
[17] Khanna N, Elzi L, Mueller N J, et al. Incidence and outcome of progressive multifocal leukoencephalopathy over20 years of the Swiss HIV cohort study[J]. Clin Infect Dis,2009,48(10): 1459-1466.
[18] Amend K L, Turnbull B, Foskett N, et al. Incidence of progressive multifocalleukoencephalopathy in patients without HIV[J]. Neurol, 2010, 75(15): 1326-1332.
[19] Melis M, Biagi C, Smabrekke L, et al. Drug-Induced Progressive Multifocal Leukoencephalopathy: A Comprehensive Analysis of the WHO AdverseDrug Reaction Database[J]. CNS Drugs, 2015, 29(10):879-891.
[20] 国家食品药品监督管理总局药品评价中心. 药物警戒快讯-美国警示芬戈莫德与严重脑部感染风险[EB/OL]. (2013-10-09)
. http://www.cdr-adr.org.cn/jjkx_258/ywjjkx/2013/201310/t20131017_5652.html.
[21] 国家食品药品监督管理总局药品评价中心. 药物警戒快讯-澳
大利亚发布药物性PML的相关信息[EB/OL]. 2013-03-28)[2016-06-15]. http://www.cdr-adr.org.cn/jjkx_258/ywjjkx/2013/201305/t20130508_5453.html.
[22] FDA. FDA Approves Resumed Marketing of TysabriUnder aSpecial Distribution Program[EB/OL]. (2006-06-05)[2016-06-15]. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html.
[23] 李行, 竟永华, 郭剑非. 那他珠单抗重返市场给药品风险管理的启示[J].中国药物警戒,2007,13（1）: 14-16, 26.