clsi2012更新中文

,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,CLSI M100-S22,更新要点,福建省医院感染质量管理控制中心,福建医科大学附属协和医院院感科,陈建森,CLSI AST StandardsJanuary 2012 Update,M100-S22 Table(2012)*,M02-A11 Disk Diffusion Method(2012)*,M07-A9 MIC Method(2012)*,M11,A7 Anaerobe MIC Testing(2007),*,每年更新一次,*每三年更新一次,Summary of the Changes,M100-S22.Page 13.,2012,主要更新,肠杆菌科,再次修订厄他培南的折点,增加环丙沙星对伤寒沙门菌及肠道外沙门菌分离株的折点,铜绿假胞菌,降低哌拉西林、哌拉西林他唑巴坦、替卡西林、替卡西林克拉维酸的折点,降低亚胺培南、美罗培南的折点；增加多尼培南的折点,葡萄球菌属,增加青霉素纸片抑菌圈边缘法检测,内酰胺酶。,New!,修订折点必须切记！,CLSI,和,FDA,设定的折点都是针对美国的。,CLSI,和,FDA,建立的折点二者有少许不同,商业化药敏系统,必须,使用,FDA,折点,临床实验室即可使用,CLSI,也可使用,FDA,折点,Remember we will not see revised CLSIbreakpoints on commercial AST devices until FDA revises those breakpoints AST manufacturers,MUST,use FDA breakpoints!,Check with manufacturer to determine which interpretive criteria are used with your AST system.,CLSI,设定、修订折点所使用的数据,“野生株”或正常微生态菌的,MIC,分布,“野生株”无获得性耐药机制,药动学药代学分析（,PK/PD,）,PK=,吸收、分布、代谢、清除,PD=,体内一定时间内药物浓度与抗微生物疗效的关系,MICs,与临床转归,对旧的药物只有极有限的新数据,CLSI M23-A3(2008)“Development of In Vitro Susceptibility Testing Criteria and QC Parameters;Approved Guideline”describes CLSI process for setting/revising breakpoints,针对,MDR,的报告制度,Section I.D.Selective Reporting,In addition,each laboratory should develop a protocol to address isolates that are confirmed as resistant to all agents on their routine test panels.This protocol should include options for testing additional agents in-house or sending the isolate to a reference laboratory.,M100-S22.P26,New!,另外，每个实验室必须建立针对对所有常规药敏测试均为耐药的制度。这种制度应包括增加实验室内部可完成测试的药物种类或必须送至参考实验室的菌株。,Specimen:Tracheal,Asspirate,Diagnosis:,Pneumoniaa,Klebsiella,pneumoniae,MIC(g/ml),amikacin,32 R,ampicillin,32 R,cefazolin,32 R,cefepime,32 R,ceftriaxone,32 R,ciprofloxacin 4 R,ertapenem,4 R,gentamicin,16R,meropenem,8 R,piperpiper-tazobactam,128R,tobramycin,16 R,trimethtrimeth,-sulfa 4/76 R,SOP,包括,:,与药学人员讨论,如合适，药学人员建议增加测试的药物名称（如多粘菌素，替加环素）,提示如何完成测试（实验室内部或送至参考实验室）,肠杆菌科厄他培南,CLSI,折点的历史演变,CLSI,Document,MIC(g/ml),Disk Diffusion(mm),Susc,Int,Res,Susc,Int,Res,M100M100-S20,(Jan.2010)*,2,4,8,19,16-18,15,M100M100-S20U,(June 2010),0.25,0.5,1,23,20-22,19,M100M100-S22,(Jan 2012)*,0.50,1.0,2,22,19-21,18,*,same as current FDA breakpoint,New!,为什么,CLSI,再次修订肠杆菌科对厄他培南的折点？,2011,折点主要基于：,MIC,分布,PK/PD,（保守的,0.25 g/ml,）,非常有限的临床数据（无,MICs,0.5 g/ml,）,2012,折点主要基于：,增加的调查数据显示分离株,MICs,0.5 g/ml,但不产生碳青霉烯酶,进一步回顾了,PK/PD,增加了临床数据（包括产,ESBL,大肠埃希菌其,MICs,0.5 g/ml,提示临床有效,）,同时，一些商品化药敏组合中厄他培南的最低浓度是,0.5 g/ml,，这样允许实验室通过验证后可直接应用,CLSI,折点。,要不要做改良,Hodge(MHT),？,实验室在使用新折点之前，必须做,MHT;,实验室在使用新折点之后，可不必做,MHT,，除非流行病学或院感控制需要。,MHT,M100-S22.P52,60,“,NOTE:Not all,carbapenemase,-producing isolates of,Enterobacteriaceae,are MHT positive and MHT-positive results may be encountered in isolates with,carbapenem,resistance mechanisms other than,carbapenemase,production.”,备注：并不是所有产碳青霉烯酶的肠杆菌科细菌,MHT,均为阳性，有些菌株,MHT,阳性但对碳青霉烯类药物耐药的机制并不一定是产碳青霉烯酶。,碳青霉烯酶分类,Class,Carbapenemase,Found in:,Notes,A,KPC,K.,pneumoniae,and,other,Enterobacteriaceae,Hydrolyze all,-lactams,Inhibited by,clavulanic,acid,SME,S.,marcescens,B,Metallo,beta-,lactamases,(IMP,VIM,GIM,SPM,NDM),P.,aeruginosa,Enterobacteriaceae,Acinetobacteer,S.,maltophilia,Hydrolyze all,-lactams,except,aztreonam,Somewhat inhibited by,clavulanic,acid,Require zinc for enzymatic,activity;inhibited by EDTA,D,OXA,Acinetobacter,baumannii,Enterobacteriaceae,Less able to hydrolyze,carbapenems,Adapted from,Queenan,&Bush.2007.,Clin,Microbiol,Rev.20:440.,MHT,对碳青霉烯酶的检出价值,MHT,2,Carbapenemase,1,Positive,(N=35),Negative,(N=19),3,Positive,24,11,Negative,7,4,7,Not interpretable,4,-,Not Done,-,2,1,、已明确,2,、用厄他培南纸片法,3,、,AmpC,过表达或,ESBL+/,膜不通透,4,、,NDM-1,（,7/14,产,NDM-1,菌,MHT,阴性）,MHT,：敏感性：,77.4%;,特异性,38.9%,MHT,对,KPC,和,OXA,检出能力好,;,对,NDM-1,检出能力低,。,Girrlich,et al.2012.J,Clin,Microbiol,.50:477.,4,株,CRE,：碳青霉烯药物,MICs,、,MHT,及内酰胺酶耐药机制,Organism,MIC(g/ml),1,MHT,Resistance,mechanism,Ertap,Imip,Mero,E.coli,2,16 R,4 R,4R,Pos,4,Plasmid,amp,C,K.pneumoniae,2,16 R,0.25 S,8R,Pos,5,ESBL,bla,shv,E.coli,3,16 R,8R,16 R,Neg,5,NDM,1,6,K.pneumoniae,3,2 R,1S,2I,Pos,5,IMP4,6,1,、,Interpreted with current breakpoints,2,、,Anderson,KF et al.2009.ICAACC.D-719.,3,、,Limbago,BM.CLSI Agenda book.January 2011.,4,、,MHT positive only with,ertapennem,disk,5,、,MHT same result with,ertapeneem,and,meropenem,(and,imipenem,)disks,6,、,Carbapenemases,(,metallo-lacctamases,),什么时候做,MHT,？,M100M100-S222.Comment(23)Page 47.,Table 2A,Supplemeental,Tables 2 and 3.Pages 52 and 56.,做,MHT,碳青霉烯酶筛查阳性,流行病学需要,如果使用新的折点,如果使用旧的折点,做,MHT,伤寒沙门菌、肠道外沙门菌属细菌与氟喹诺酮药物,伤寒沙门菌及肠道外沙菌感染，临床上因菌株对环丙沙星敏感性下降而使疗效反应较差。,以前研究表明可用萘啶酸试验,但用萘啶酸试验无法检出导致环丙沙星敏感性降低的新耐药机制。,2012,新的环丙沙星折点,对“中介”菌株有新的评论,修订萘啶酸试验的推荐范围。,肠杆菌科（包括星沙门菌属）环丙沙星新、旧折点比较,DD(mm),MIC(g/ml),Susc,Int,Res,Susc,Int,Res,21,16-20,15,1,2,4,Organism,DD(mm),MIC(g/ml),Suscc,Int,Res,Susc,Int,Res,Enterobacteriaceae,other than,S.,typhi,and,extraintestinal,SSalmonella,spp.,21,16-20,15,1,2,4,S.,typhi,and,extraintestinal,Salmonella,spp.,31,21-30,20,0.06,0.12-0.5,1,M100-S21,P46,M100-S22,P48,New!,伤寒沙门菌、肠道外沙门菌属细菌萘啶酸试验,萘啶酸试验尽管不是最理想的，但仍在,M100-S22,备注中保留：,extraintestinal,Salmonella infections.Strains of Salmone