학술논문
Vasculitis as an adverse event following immunization - Systematic literature review.
Document Type
Academic Journal
Author
Bonetto C; Italian Medicines Agency (AIFA), Rome, Italy. Electronic address: contact@brightoncollaboration.org.; Trotta F; Italian Medicines Agency (AIFA), Rome, Italy.; Felicetti P; Italian Medicines Agency (AIFA), Rome, Italy.; Alarcón GS; The University of Alabama at Birmingham, USA.; Santuccio C; Italian Medicines Agency (AIFA), Rome, Italy.; Bachtiar NS; Bio Farma Vaccine Institute, Bandung, West Java, Indonesia.; Brauchli Pernus Y; Brighton Collaboration Foundation, Basel, Switzerland.; Chandler R; Uppsala Monitoring Centre, Uppsala, Sweden.; Girolomoni G; Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.; Hadden RD; King's College Hospital, London, United Kingdom.; Kucuku M; Department of Vaccines Control, National Agency for Medicines and Medical Devices, Tirana, Albania.; Ozen S; Department of Pediatric Rheumatology, Hacettepe University, Ankara, Turkey.; Pahud B; Children's Mercy Hospital, Kansas City, MO, USA.; Top K; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.; Varricchio F; Independent Consultant Vaccinologist, Wakefield, RI, USA.; Wise RP; MedImmune/AstraZeneca, Gaithersburg, MD, USA.; Zanoni G; Immunology Unit, Policlinico G.B. Rossi, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.; Živković S; University of Pittsburgh Medical Center, Pittsburgh, USA.; Bonhoeffer J; Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children's Hospital, Basel, Switzerland.
Source
Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Several types of vasculitis have been observed and reported in temporal association with the administration of various vaccines. A systematic review of current evidence is lacking.
Objective: This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI).
Methods: We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population.
Results: The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis.
Conclusions: Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization.
(Published by Elsevier Ltd.)
Objective: This systematic literature review aimed to assess available evidence and current reporting practice of vasculitides as adverse events following immunization (AEFI).
Methods: We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprises randomized controlled trials, observational studies, case series, case reports, reviews and comments regardless of vaccine and target population.
Results: The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessed for eligibility and 75 studies were considered for analysis, including 6 retrospective/observational studies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Most of the larger, higher quality studies found no causal association between vaccination and subsequent development of vasculitis, including several studies on Kawasaki disease and Henoch-Schönlein purpura (IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines against influenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis.
Conclusions: Existing literature does not allow establishing a causative link between vaccination and vasculitides. Further investigations were strengthened by the use of standardized case definitions and methods for data collection, analysis and presentation to improve data comparability and interpretation of vasculitis cases following immunization.
(Published by Elsevier Ltd.)