[1] Crawford N W, Clothier H,Hodgson K, et al. Active surveillance for adverse events following immunization[J]. Expert RevVaccines, 2014,13(2):265-276. [2] 董铎,田春华,孙利华.我国疫苗不良事件监测体系现状及思考[J].中国药物警戒, 2007,4(5):261-264. [3] 王丹.药品不良反应主动监测及其发展趋势[J]. 中国药物警戒, 2015,12(10):600-602. [4] 王胜锋,詹思延.大数据时代的药品安全主动监测:对照选择的挑战与机遇[J].中华流行病学杂志, 2016,37(7):909-916. [5] 张倩婷,王亚丽,曲毅.我国疫苗上市后主动监测模式的探讨[J].中国药物警戒, 2016,13(11):673-675. [6] WHO. The WHO Programme for International Drug Monitoring (PIDM)[EB/OL].(2017-03-15)[2017-03-15]. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map. [7] Chen R T, Rastogi S C, Mullen J R, et al.The vaccine adverse event reporting system (VAERS)[J]. Vaccine, 1994,12(6):542-550. [8] MHRA. Yellow Card Scheme[EB/OL].(2017-03-15)[2017-03-15].https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/. [9] PHAC.Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)[EB/OL].(2016-12-09)[2017-03-15].http://www.phac-aspc.gc.ca/im/vs-sv/. [10] International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals For Human Use (ICH). ICH Harmonised Tripartite Guideline. Post-approval safety data management: definitions and standards for expedited reporting[J/OL].(2003-11-12)[2017-03-15]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf. [11] Fletcher A P. Spontaneous adverse drug reaction reporting vs event monitoring:a comparison[J].JRSoc Med, 1991,84(6):341-344. [12] Rosenthal S, Chen R T. The report in sensitivities of two passive surveillance systems for vaccine adverse events[J].Am JPublic Health, 1995,85(12):1706-1709. [13] Isaacs D, Lawrence G, Boyd I, et al. Reporting of adverse events following immunization in Australia[J].J. Paediatr Child Health, 2005,41(4):163-166. [14] Waldman E A, Luhm K R, Monteiro S A, et al. Surveillance of adverse effects following vaccination and safety of immunization programs[J]. RevSaudePublica, 2011,45(1):173-184. [15] Donegan K, Beau-Lejdstrom R, King B, et al. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK[J]. Vaccine, 2013,31(43):4961-4967. [16] Coloma P M, Schuemie M J, Trifiro G, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project[J]. Pharmacoepidemiol Drug Saf, 2011,20(1):1-11. [17] Andersen M, Bergman U, Choi N K, et al. The Asian Pharmacoepid-emiology Network (AsPEN):promoting multi-national collaboration for pharmacoepidemiologic research in Asia[J].Pharmacoepidemiol Drug Saf, 2013,22(7):700-704. [18] Chen R T, Glasser J W, Rhodes P H., et al. Vaccine Safety Datalinkproject: a new tool for improving vaccine safety monitoring in the United States[J]. Pediatrics, 1997,99(6):765-773. [19] Nguyen M, Ball R, Midthun K, et al. The Food and Drug Administration's Post-licensure RapidImmunization Safety Monitoring program: strengthening thefederal vaccine safety enterprise[J]. Pharmacoepidemiol Drug Saf, 2012,21(S1):291-297. [20] Scheifele D W, Halperin S A, Members of the CPS/Health Canada. Immunization Monitoring Program, Active: a model of active surveillance of vaccine safety[J]. SeminPediatr Infect Dis, 2003,14(3):213-219. [21] Pillsbury A, Cashman P, Leeb A, et al. Real-time safety surveillance of seasonalinfluenza vaccines in children, Australia, 2015[J]. Euro Surveill, 2015,20(43):1-5. [22] Klein N P, Fireman B, Yih W K, et al. Measles-mumps-rubella-varicella combination vaccine and the riskof febrile seizures[J]. Pediatrics, 2010,126(1):e1-e8. [23] Yih W K, Lee G M, Lieu T A, et al. Surveillance for adverse events following receipt of pandemic 2009 H1N1vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM)system, 2009-2010[J]. Am J Epidemiol, 2012,175(11):1120-1128. [24] Saux N L, Barrowman N J, Moore D L, et al. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT[J]. Pediatrics, 2003,112(5):e348-e353. [25] Ali M, Canh D G, Clemens J D, et al. The vaccine data link in NhaTrang, Vietnam: a progress report on theimplementation of a database to detect adverse eventsrelated to vaccinations[J]. Vaccine, 2003,21(15):1681-1686. [26] Aronson J K, Hauben M, Bate A. Defining 'surveillance' in drug safety[J].Drug Saf, 2012,35(5):347. [27] Petrov A. Complications in the cardiovascular system fromneurol-eptictreatment[J]. Vutr Boles, 1987,26(5):72-76. [28] Farrington P, Pugh S, Colville A, et al. A new method foractive surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines[J].Lancet, 1995,345 (8949):567-569. [29] Weaver J, Willy M, Avigan M. Informatic tools and approachesin-postmarketingpharmacovigilance used byFDA[J]. AAPS J, 2008,10(1):35-41. [30] Council for International Organizations of Medical Sciences (CIOMS). Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII[M]. Geneva: CIOMS,2010. [31] Huang Y L, Moon J, Segal J B. A comparison of active adverse event surveillance systemsworldwide[J]. Drug Saf, 2014,37:581-596. [32] Waldman E A, Luhm K R, Monteiro S A, et al. Surveillance of adverse effects following vaccination and safety of immunization programs[J]. Rev SaudePublica, 2011,45(1):1-11. [33] Cassidy C, MacDonald N E, Steenbeek A, et al. Adverse event following immunization surveillance systems forpregnant women and their infants: a systematic review[J]. PharmacoepidemiolDrug Saf,2015,24(4):361-367. [34] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH). Harmonised Tripartite Guideline. PharmacovigilancePlanning[J/OL].(2003-11-12)[2017-03-15]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf. [35] Baker M A, Nguyen M, Cole D V, et al. Post-licensure rapid immunization safety monitoring program(PRISM) data chara-cterization[J]. Vaccine, 2013,31S(10):K98-K112. [36] Center of Disease Prevention and Control (CDC). Vaccine Safety Datalink (VSD)[EB/OL].(2016-05-13)[2017-03-15].http://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html. [37] Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety[J]. Pediatrics, 2011,127(S1):45-53. [38] Bettinger J A, Halperin S A, Vaudry W, et al. The Canadian Immunization Monitoring Program, ACTive (IMPACT): active surveillance for vaccine adverse events and vaccine-preventable diseases[J]. CCDR, 2014,40(S3):41-44. [39] Scheifele D W. IMPACT after 17 years: lessons learned about successful networking[J]. Paediatr Child Health, 2009,14(1):33-35. [40] Cashman P, Moberley S, Dalton C, et al. Vaxtracker: Active on-line surveillance for adverse events following inactivated influenza vaccine in children[J]. Vaccine, 2014,32(42):5503-5508. [41] Leeb A, Regan A K, Peters IJ, et al. Using automated text messages to monitor adverse events following immunisation in general practice[J]. Med J Aust, 2014,200(7):416-418. [42] Curtis L H, Weiner M G,Boudreau D M, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data system[J].PharmacoepidemiolDrug Saf, 2012,21(S1):23-31. [43] Lieu T A, Kulldorff M, Davis R L, et al. Real-time vaccine safety surveillance forthe early detection of adverse events[J]. MedCare, 2007,45(S2):89-95. |