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《规范》及指导原则适用于食品药品监管部门对第三类医疗器械批发/零售经营企业经营许可（含变更和延续）的现场核查，第二类医疗器械批发/零售经营企业经营备案后的现场核查，以及医疗器械经营企业的各类监督检查 　　　　　　　　　　　　　 Management of Atrial Fibrillation： Update in the EBM proof ChangSheng Ma Department of Cardiology, Beijing Anzhen Hospital Capital Medical University, P.R. China Prevalence of AF is increasing Adults with AFib (millions) Year 2.08 2.26 2.44 2.66 2.94 3.33 3.80 4.78 4.34 5.16 5.42 5.61 % 36 37 53 Year Proportion Aged ?80 Yr Go: JAMA, 2001：2370 Miyasaka.Circulation.2006:119 Year 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0 2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050 Adults with AFib (millions) 5.1 10.2 8.4 12.1 15.9 Prevalence of AF is increasing Prevalence % Age Prevalence of AF:the Rotterdam study Heerinaga.Eur Heart J,2006,949 6808 pts., F/U 6.9 yrs，prevalence 5.5% Incidence ‰ Age Incidence of AF:the Rotterdam study Heerinaga.Eur Heart J,2006,949 6808 pts., F/U 6.9 yrs，Incidence 9.9‰ Identified AF：the tip of the iceberg 14802 pts aged 65 or over，randomized to systemic screening and opportunistic screening Systemic screening group:9866 pts. Opportunistic screening group: 4936 pts. F/U 12 mons Rate of new AF case in systemic screening 1.63%， Rate of new AF case in opportunistic screening 1.04% Fitzmaurice.BMJ.2007,383 Risk for stroke increased in lone AF Jahangir. Circulation. 2007:3050 Meta-analysis: antithrombotic therapy of AF Hart.Ann Intern Med,2007,857 trial pts RR reduced(%) Warfarin vs Placebo 6 2900 64 ASA vs Placebo 8 4876 22 Warfarin vs ASA 12 12963 39 Real world of warfarin in the elderly 13.1% 4.7% The first 90 days associated with major hemorrhage 21% pts withdrawn warfarin for safety issue The higher risk of stroke, the higher incidence of major hemorrhage Hylek. Circulation.2007,2689 HR for ICH was 4.06 for Asians Asians were at greater risk for warfarin-ralated ICH Shen. JACC.2007:309 Prospective，randomize，control 973 pts ?75 years old with AF Randomized into warfarin arm (INR 2.0-3.0) and Aspirin arm(75mg/d) Mea