کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8486193 | 1551765 | 2018 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination
ترجمه فارسی عنوان
افزایش داروی هضم جهانی واکسن جهانی: بررسی اثربخشی مفهوم مننژیت آسپتیک و پورپورای ترومبوسیتوپنیک ایمنی پس از سرخک و واکسیناسیون
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کلمات کلیدی
PMNsFDAAdverse events following immunization (AEFI)AEFILMICsMMRSCCsIRREMCVaccine safety - ایمنی واکسنAdverse Events Following Immunization - رویدادهای ناخوشایند بعد از ایمن سازیWorld Health Organization - سازمان بهداشت جهانیFood and Drug Administration - سازمان غذا و داروSelf-controlled case series - سری موارد خود کنترل شدهconfidence interval - فاصله اطمینانpolymorphonuclear leukocytes - لکوسیت های پلی مورفونیک هسته ایCSF - مایع مغزی نخاعیCerebrospinal fluid - مایع مغزی نخاعیaseptic meningitis - مننژیت آسپتیکodds ratio - نسبت شانس هاincidence rate ratio - نسبت میزان بروزPost-marketing surveillance - نظارت پس از بازاریابیITP - و غیره.Immune thrombocytopenic purpura - پالپور ترومبوسیتوپنی ایمنیLow and Middle-Income Countries - کشورهای کم درآمد و متوسط درآمدWHO - که
موضوعات مرتبط
علوم زیستی و بیوفناوری
ایمنی شناسی و میکروب شناسی
ایمونولوژی
چکیده انگلیسی
New vaccines designed to prevent diseases endemic in low and middle-income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital-based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis. The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5-9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2-27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7-157.6), Edmonston-Zagreb (IRR: 11.1; 95% CI: 1.4-90.3), and Enders'Edmonston (IRR: 8.5; 95% CI: 1.9-38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3-87.4) was also found. This proof-of-concept study has shown, for the first time, that an international hospital-based network for the investigation of rare vaccine adverse events, using common standardized procedures and with high participation of LMICs, is feasible, can produce reliable results, and has the potential to characterize differences in risk between vaccine strains. The completion of this network by adding large reference hospitals, particularly from tropical countries, and the systematic WHO-led implementation of this approach, should permit the rapid post-marketing evaluation of safety signals for serious and rare adverse events for new and existing vaccines in all settings, including LMICs.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Vaccine - Volume 36, Issue 3, 8 January 2018, Pages 347-354
Journal: Vaccine - Volume 36, Issue 3, 8 January 2018, Pages 347-354
نویسندگان
Silvia Perez-Vilar, Daniel Weibel, Miriam Sturkenboom, Steven Black, Christine Maure, Jose Luis Castro, Pamela Bravo-Alcántara, Caitlin N. Dodd, Silvana A. Romio, Maria de Ridder, Swabra Nakato, Helvert Felipe Molina-León, Varalakshmi Elango,