Guillain–Barré syndrome and Fisher syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety data

Vaccine - Tập 29 Số 3 - Trang 599-612 - 2011
James J. Sejvar1, Katrin Kohl1, Jane Gidudu1, Anthony A. Amato2, Nandini Bakshi3, Roger Baxter3, Dale R. Burwen4, Kristl G. Claeys5, Jan Bonhoeffer6, Kathryn M. Edwards7, Ulrich Heininger8, Richard AC Hughes9, Najwa Khuri‐Bulos10, Rudolf Korinthenberg11, Barbara Law12, Ursula Munro13, Helena C. Maltezou14, Patricia Nell15, James M. Oleske16, Robert Sparks17, Priscilla Velentgas18, Patricia Vermeer19, Max Wiznitzer20
1Centers for Disease Control and Prevention, Atlanta, GA USA
2Department of Neurology, Division of Neuromuscular Disease, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA
3NCK Kaiser Permanente, Oakland, CA, USA
4Food and Drug Administration, Rockville, MD, USA
5John Hopkins University/School of Medicine, Baltimore, MD, USA
6GlaxoSmithKline#N# Biologicals, Rixensart, Belgium
7Vanderbilt University School of Medicine, Nashville, TN USA
8University Children’s Hospital, Basel, Switzerland
9King's College London
10Jordan University Hospital, Amman, Jordan
11University Hospital Freiburg, Freiburg, Germany
12Public Health Agency of Canada, Ottawa, Ontario, Canada
13Sanofi Pasteur MSD GmbH, Walldorf, Germany
14Hellenic Center for Disease Control and Prevention, Athens, Greece
15Airforce Reserve Command, United States Air Force, Sturgeon Bay, WI, USA
16University Hospital, New Jersey Medical School, Morris Plains, NJ, USA
17Vanderbilt University Medical Center, Nashville, TN, USA -
18Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
19National Institute of Public Health and Environment, Bilthoven, The Netherlands
20Department of Neurology, University Hospitals of Cleveland, Cleveland, OH, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Kohl, 2007, The development of standardized case definitions and guidelines for adverse events following immunization, Vaccine, 25, 5671, 10.1016/j.vaccine.2007.02.063

Hughes, 2005, Guillain–Barre syndrome, Lancet, 366, 1653, 10.1016/S0140-6736(05)67665-9

Willison, 2005, The immunobiology of Guillain–Barre syndromes, J Peripher Nerv Syst, 10, 94, 10.1111/j.1085-9489.2005.0010202.x

Hughes, 1999, Pathogenesis of Guillain–Barre syndrome, J Neuroimmunol, 100, 74, 10.1016/S0165-5728(99)00195-2

Asbury, 1990, Guillain–Barre syndrome: historical aspects, Ann Neurol, 27 Suppl, S2, 10.1002/ana.410270703

Alter, 1990, The epidemiology of Guillain–Barre syndrome, Ann Neurol, 27, S7, 10.1002/ana.410270704

Govoni, 2001, Epidemiology of the Guillain–Barre syndrome, Curr Opin Neurol, 14, 605, 10.1097/00019052-200110000-00009

McGrogan, 2008, The epidemiology of Guillain–Barre Syndrome worldwide. A systematic literature review, Neuroepidemiology, 32, 150, 10.1159/000184748

Schoenberg, 1978, Epidemiology of Guillain–Barre syndrome, Adv Neurol, 19, 249

Hughes, 1997, Clinical and epidemiologic features of Guillain–Barre syndrome, J Infect Dis, 176, S92, 10.1086/513793

Orlikowski, 2004, Respiratory dysfunction in Guillain–Barre syndrome, Neurocrit Care, 1, 415, 10.1385/NCC:1:4:415

Fletcher, 2000, Long-term outcome in patients with Guillain–Barre syndrome requiring mechanical ventilation, Neurology, 54, 2311, 10.1212/WNL.54.12.2311

Cornblath, 2006, Guillain–Barre syndrome, 695, 10.1016/S1567-4231(09)70095-4

Jones, 1995, Guillain–Barre syndrome in children, Curr Opin Pediatr, 7, 663

Sladky, 2004, Guillain–Barre syndrome in children, J Child Neurol, 19, 191

Singh, 1994, Prognostic factors in Guillain–Barre’ syndrome, J Assoc Phys India, 42, 777

Rees, 1998, Epidemiological study of Guillain–Barre syndrome in south east England, J Neurol Neurosurg Psychiatry, 64, 74, 10.1136/jnnp.64.1.74

Asbury, 2000, New concepts of Guillain–Barre syndrome, J Child Neurol, 15, 183, 10.1177/088307380001500308

Griffin, 1995, Guillain–Barre syndrome in northern China. The spectrum of neuropathological changes in clinically defined cases, Brain, 118, 577, 10.1093/brain/118.3.577

McKhann, 1993, Acute motor axonal neuropathy: a frequent cause of acute flaccid paralysis in China, Ann Neurol, 33, 333, 10.1002/ana.410330402

Overell, 2005, Recent developments in Miller Fisher syndrome and related disorders, Curr Opin Neurol, 18, 562, 10.1097/01.wco.0000173284.25581.2f

Yuan, 2000, Miller Fisher syndrome: a hospital-based retrospective study, Eur Neurol, 44, 79, 10.1159/000008201

Hadden, 1998, Electrophysiological classification of Guillain–Barre syndrome: clinical associations and outcome. Plasma Exchange/Sandoglobulin Guillain–Barre Syndrome Trial Group, Ann Neurol, 44, 780, 10.1002/ana.410440512

Griffin, 1996, Pathology of the motor-sensory axonal Guillain–Barre syndrome, Ann Neurol, 39, 17, 10.1002/ana.410390105

Mizoguchi, 1998, Anti-GQ1b IgG antibody activities related to the severity of Miller Fisher syndrome, Neurol Res, 20, 617, 10.1080/01616412.1998.11740573

Rees, 1995, Campylobacter jejuni infection and Guillain–Barre syndrome, N Engl J Med, 333, 1374, 10.1056/NEJM199511233332102

Schmidt-Ott, 2006, Improved serological diagnosis stresses the major role of Campylobacter jejuni in triggering Guillain–Barre syndrome, Clin Vaccine Immunol, 13, 779, 10.1128/CVI.00065-06

Jacobs, 1998, The spectrum of antecedent infections in Guillain–Barre syndrome: a case-control study, Neurology, 51, 1110, 10.1212/WNL.51.4.1110

Mori, 1999, Haemophilus influenzae has a GM1 ganglioside-like structure and elicits Guillain–Barre syndrome, Neurology, 52, 1282, 10.1212/WNL.52.6.1282

Nakamura, 2008, Infectious agents as the triggers for the pathogenesis of the neuroimmunological disorders, Nippon Rinsho, 66, 1056

Susuki, 2004, Acute motor axonal neuropathy after Mycoplasma infection: evidence of molecular mimicry, Neurology, 62, 949, 10.1212/01.WNL.0000115123.42929.FD

Tam, 2006, Influenza, Campylobacter and Mycoplasma infections, and hospital admissions for Guillain–Barre syndrome, England, Emerg Infect Dis, 12, 1880, 10.3201/eid1212.051032

Wanschitz, 2006, Acute motor and sensory axonal neuropathy in Burkitt-like lymphoma, Muscle Nerve, 34, 494, 10.1002/mus.20569

Koffman, 2006, Neurologic complications after surgery for obesity, Muscle Nerve, 33, 166, 10.1002/mus.20394

Kalume, 2004, Molecular mimicry: cross-reactive antibodies from patients with immune-mediated neurologic disease inhibit neuronal firing, J Neurosci Res, 77, 82, 10.1002/jnr.20137

Levin, 1998, Neuronal molecular mimicry in immune-mediated neurologic disease, Ann Neurol, 44, 87, 10.1002/ana.410440115

1998

Miller, 2001, Multiple pathways to induction of virus-induced autoimmune demyelination: lessons from Theiler's virus infection, J Autoimmun, 16, 219, 10.1006/jaut.2000.0489

Olson, 2002, Functional activation of myelin-specific T cells by virus-induced molecular mimicry, J Immunol, 169, 2719, 10.4049/jimmunol.169.5.2719

Piyasirisilp, 1999, Association of HLA and T-cell receptor gene polymorphisms with Semple rabies vaccine-induced autoimmune encephalomyelitis, Ann Neurol, 45, 595, 10.1002/1531-8249(199905)45:5<595::AID-ANA7>3.0.CO;2-M

Hemachudha, 1987, Neurologic complications of Semple-type rabies vaccine: clinical and immunologic studies, Neurology, 37, 550, 10.1212/WNL.37.4.550

Hemachudha, 1987, Myelin basic protein as an encephalitogen in encephalomyelitis and polyneuritis following rabies vaccination, N Engl J Med, 316, 369, 10.1056/NEJM198702123160703

Langmuir, 1979, Guillain–Barre syndrome: the swine influenza virus vaccine incident in the United States of America, 1976–77: preliminary communication, J R Soc Med, 72, 660, 10.1177/014107687907200908

Schonberger, 1979, Guillain–Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977, Am J Epidemiol, 110, 105, 10.1093/oxfordjournals.aje.a112795

Nachamkin, 2008, Anti-ganglioside antibody induction by swine (A/NJ/1976/H1N1) and other influenza vaccines: insights into vaccine-associated Guillain–Barre syndrome, J Infect Dis, 198, 226, 10.1086/589624

Juurlink, 2006, Guillain–Barre syndrome after influenza vaccination in adults: a population-based study, Arch Intern Med, 166, 2217, 10.1001/archinte.166.20.2217

Hughes, 2006, No association between immunization and Guillain–Barre syndrome in the United Kingdom, 1992 to 2000, Arch Intern Med, 166, 1301, 10.1001/archinte.166.12.1301

Haber, 2004, Guillain–Barre syndrome following influenza vaccination, JAMA, 292, 2478, 10.1001/jama.292.20.2478

Roscelli, 1991, Guillain–Barre syndrome and influenza vaccination in the US Army, 1980–1988, Am J Epidemiol, 133, 952, 10.1093/oxfordjournals.aje.a115974

Kaplan, 1983, Guillain–Barre syndrome in the United States, 1978–1981: additional observations from the national surveillance system, Neurology, 33, 633, 10.1212/WNL.33.5.633

Lasky, 1998, The Guillain–Barre syndrome and the 1992–1993 and 1993–1994 influenza vaccines, N Engl J Med, 339, 1797, 10.1056/NEJM199812173392501

Safranek, 1991, Reassessment of the association between Guillain–Barre syndrome and receipt of swine influenza vaccine in 1976–1977: results of a two-state study. Expert Neurology Group, Am J Epidemiol, 133, 940, 10.1093/oxfordjournals.aje.a115973

Stowe, 2009, Investigation of the temporal association of Guillain–Barre syndrome with influenza vaccine and influenza-like illness using the United Kingdom General Practice Research Database, Am J Epidemiol, 169, 382, 10.1093/aje/kwn310

Cornblath, 1990, Electrophysiology in Guillain–Barre syndrome, Ann Neurol, 27 Suppl, S17, 10.1002/ana.410270706

Kalita, 2008, Neurophysiological criteria in the diagnosis of different clinical types of Guillain–Barre syndrome, J Neurol Neurosurg Psychiatry, 79, 289, 10.1136/jnnp.2007.118000

Raphael, 2002, Plasma exchange for Guillain–Barre syndrome, Cochrane Database Syst Rev, CD001798

Hughes, 2003, Practice parameter: immunotherapy for Guillain–Barre syndrome: report of the Quality Standards Subcommittee of the American Academy of Neurology, Neurology, 61, 736, 10.1212/WNL.61.6.736

Hughes, 2004, Intravenous immunoglobulin for Guillain–Barre syndrome, Cochrane Database Syst Rev, CD002063

Smith, 1992, Plasma exchange treatment and prognosis of Guillain–Barre syndrome, Q J Med, 85, 751

Urtasun, 1992, High-dose intravenous immune globulin in the management of severe Guillain–Barre syndrome, Ann Pharmacother, 26, 32, 10.1177/106002809202600108

Hughes, 2000, Corticosteroids for treating Guillain–Barre syndrome, Cochrane Database Syst Rev, CD001446

Singh, 1996, Do corticosteroids influence the disease course or mortality in Guillain–Barre syndrome?, J Assoc Physicians India, 44, 22

Fross, 1987, Neuropathy in the Miller Fisher syndrome: clinical and electrophysiologic findings, Neurology, 37, 1493, 10.1212/WNL.37.9.1493

Govoni, 1999, The frequency of clinical variants of Guillain–Barre syndrome in Ferrara, Italy, J Neurol, 246, 1010, 10.1007/s004150050505

Scelsa, 2000, Miller Fisher syndrome: axonal, demyelinating or both?, Electromyogr Clin Neurophysiol, 40, 497

Ruts, 2005, Distinguishing acute-onset CIDP from Guillain–Barre syndrome with treatment related fluctuations, Neurology, 65, 138, 10.1212/01.wnl.0000167549.09664.b8

Van den Bergh, 2004, Electrodiagnostic criteria for acute and chronic inflammatory demyelinating polyradiculoneuropathy, Muscle Nerve, 29, 565, 10.1002/mus.20022

Mazor, 2003, Interpretation of traumatic lumbar punctures: who can go home?, Pediatrics, 111, 525, 10.1542/peds.111.3.525

Haslan, 2004, Neurologic Evaluation, 1973

Zuckermann, 1999

Jones, 2000, Guillain–Barre syndrome: perspectives with infants and children, Semin Pediatr Neurol, 7, 91, 10.1053/pb.2000.6690

Masucci, 1971, Diagnostic criteria for the Guillain–Barre syndrome. An analysis of 50 cases, J Neurol Sci, 13, 483, 10.1016/0022-510X(71)90010-4

van der Meche, 1991, Current diagnostic criteria for Guillain–Barre syndrome, Ann Neurol, 30, 851, 10.1002/ana.410300618

Asbury, 1990, Assessment of current diagnostic criteria for Guillain–Barre syndrome, Ann Neurol, 27, S21, 10.1002/ana.410270707

Meulstee, 1995, Electrodiagnostic criteria for polyneuropathy and demyelination: application in 135 patients with Guillain–Barre syndrome. Dutch Guillain–Barre Study Group, J Neurol Neurosurg Psychiatry, 59, 482, 10.1136/jnnp.59.5.482

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Efficacy Guidelines, New Codification as per November 2005 (E2A-E) [cited 2009 November 23]; Available from: http://www.ich.org/cache/compo/276-254-1.html.

Council for International Organizations of Medical Sciences. Suspect Adverse Reaction Report Form (CIOMS I Form). August 3, 2009 [cited 2009 November 23]; Available from: http://www.cioms.ch/.

Hemachudha, 1988, Immunologic studies of rabies vaccination-induced Guillain–Barre syndrome, Neurology, 38, 375, 10.1212/WNL.38.3.375

Des Jarlais, 2004, Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement, Am J Public Health, 94, 361, 10.2105/AJPH.94.3.361

Moher, 1999, Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-Analyses, Lancet, 354, 1896, 10.1016/S0140-6736(99)04149-5

Moher, 2001, The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials, JAMA, 285, 1987, 10.1001/jama.285.15.1987

Stroup, 2000, Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group, JAMA, 283, 2008, 10.1001/jama.283.15.2008

von Elm, 2008, The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies, J Clin Epidemiol, 61, 344, 10.1016/j.jclinepi.2007.11.008

Gidudu, 2008, A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data, Vaccine, 26, 6800, 10.1016/j.vaccine.2008.10.006

Hughes, 2007, Immunotherapy for Guillain–Barre syndrome: a systematic review, Brain, 130, 2245, 10.1093/brain/awm004