美爱克产品资料.pptx

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,2019/7/31,#,美爱克,头孢妥仑匹酯片,明治医药有限公司,明天更健康,第一代,头孢氨苄,头孢拉,定（泛捷复）,头孢羟氨苄,第二代,第三代,新三代,口服头孢菌素,头孢克,洛（希刻劳）,头孢丙,烯（施复捷）,头孢呋辛,酯（西力欣）,头孢克,肟（世福素）,头,孢地尼（希福尼）,头,孢泊肟酯（搏拿）,头孢妥仑匹,酯（美爱克）,提高了对革兰阳性菌的抗菌活性,口服头孢菌素类抗生素的发展史,抗菌活性,对,-,内酰胺酶稳定性,对,G,+,菌,对,G,-,菌,金葡,菌,G,-,杆菌,+,+,+,+,+,+,+,+,+,+,+,+,+,+,+,+,抗菌活性强,2,对,-,内酰胺酶稳定，不易耐药,4,广谱抗菌、均衡覆盖,G+/,G-,及厌氧菌,3,1,对耐,药菌高敏感性,3,3,高安全性，低副作用,3,5,美爱克的总体特征,全面覆盖临床上常见的,G+/,G-,及厌氧菌,革兰阳性菌,葡萄球菌,属（,金黄色葡萄球菌,）、,链球菌,属（,肺炎链球菌、化脓性链球菌,）、,消化链球菌属,广谱抗菌，,G+/,G-,及厌氧菌均,衡覆盖,革兰阴性菌,大肠埃希菌、枸橼酸杆菌属、克雷伯杆菌属、肠杆菌属、沙雷菌属、变形杆菌属、摩根杆菌属、普罗威登菌属、,卡他莫拉菌,、,流感嗜血杆菌,、痤,疮丙酸杆菌,美爱克,的抗菌谱,1,、广谱抗菌、均衡覆盖,G+/,G-,及厌氧菌,美爱克的总体特征,厌氧菌,拟杆菌属,美爱,克均衡覆盖呼吸系统,5,大致病菌,流感嗜血杆菌,卡他莫拉菌,金黄色葡萄球菌,肺炎练球菌,化脓性链球菌,美爱,克均衡覆盖呼吸系统,5,大致病菌,口服抗生素,对呼,吸系,统,5,大,致,病菌的,MIC,90,值,敏感的金黄色葡萄球菌,(100,株,),敏感的肺炎链球菌,(50,株,),中介和耐药的肺炎链球菌,(PISP+PRSP,共,50,株,),化脓链球菌,(50,株,),流感嗜血杆菌,(BLNAR9,41,株,),卡他莫拉菌,(50,株,),美爱克,0.5,0.25,0.25,0.06,0.06,0.25,头孢克肟,(,世福素,),8,4,8,0.13,0.25,1,头孢泊肟,(,搏拿,),2,0.5,2,0.06,0.5,1,头孢特仑,(,富山龙,),2,0.5,1,0.06,0.06,2,头孢地尼,(,希福尼,),0.25,0.5,4,0.06,1,0.25,对呼吸系统感染症主要致病菌更全面、更均衡的抗菌活性,金黄葡萄球菌,MSSA,肺炎链球菌,流感嗜血杆菌,副流感嗜血,杆菌,肺炎克雷伯,杆菌,菌株数,0.031,0.063,0.125,0.25,0.5,1,2,4,8,1,6,32,64,128,256,14,18,18,24,34,头孢妥仑（美爱克）,头孢,呋辛（,西力欣,）,头孢克,洛（希刻劳）,头孢氨苄,256,MIC,90,(,m,g/ml),4,种头孢类药物对临床分离致病菌的,MIC,90,值,(2001-2002,年美爱克上市后临床试验结果,),Natl Med J China,March 10,2003,Vol 83,No.5,2,、抗菌活性强,美爱克的总体特征,分离菌株,(,菌株编号,),MIC90(mg/L),金黄色葡萄链球菌,MSSA,(50),肺炎链球菌,(74,80,122),流感嗜血杆菌,化脓性链球菌,(54),卡他莫拉菌,内酰胺酶,(+),(27),内酰胺酶,(-),(23),内酰胺酶,(+),(18),内酰胺酶,(-),(12),头孢妥仑,0.5,1(80),0.063,0.016,0.031,0.125,0.008,头孢克肟,4,32(80),0.063,0.063,0.125,0.008,0.008,头孢地尼,0.5,8(102),1,0.5,0.063,0.25,0.125,头孢呋辛,1,16(74),1,0.5,0.031,1,0.25,头孢克洛,2,256(74),16,2,0.5,1,0.5,氨苄青霉素,/,克拉维酸,1,4(80),2,1,0.031,0.008,0.008,红霉素,256,256(80),8,4,256,0.25,0.25,2,、抗菌活性强,各种抗生素对小儿急性呼吸道感染分离致病菌的,MIC90,引自,:Yonghong Yang,P2-015,，,10th WPCCID,，,2006,美爱克的总体特征,致病菌种类,株数,清除,未清除,替换,清除率,革兰阳性菌,45,44,1,2,97.8%,肺炎链球菌,13,13,0,0,金黄葡萄球菌,14,14,0,2,链球菌属,18,17,1,0,革兰阴性菌,107,103,4,3,96.3%,流感嗜血杆菌,19,19,0,0,副流感嗜血杆菌,24,24,0,0,卡他莫拉菌,11,11,0,0,肺炎克雷伯菌,29,26,3,1,大肠埃希菌,10,10,0,0,其他革兰阴性菌,14,13,1,2,总计,152,147,5,5,96.7%,Natl Med J China,March 10,2003,Vol 83,No.5,细菌学清除结果,（,2001-2002,年美爱克上市后临床试验）,2,、抗菌活性强,美爱克的总体特征,2,、抗菌活性强,美爱克的总体特征,88.6,85.7,90,75,91.6,86.3,91.9,92.6,95.9,88.9,92.6,98.2,100,83.9,83.2,85.4,93.3,76.4,0 20 40 60 80 100,（）,In-house data summarized from:CHEMOTHERAPY 40(S-2),1992.Kawamura,S.,et al.:Otologia Fukuoka 38(5):644,1992.Okada,K,et al.,World of Obstotrics and Gynecology 45(2):149,1993.Sasaki,j.,et al.,Oral Therapeutics and Pharmacology 11(2):112,1992.Baba,S.,et al.,:Otologia Fukuoka 38(5):663,1992.,106,60,48,214,31,11,52,94,9,122,27,37,102,297,8,20,28,633,金黄葡萄球菌,表皮葡萄球菌,其它葡萄球菌,分离葡萄球菌株总数,肺炎链球菌,化脓性链球菌,其它链球菌,分离链球菌株总数,卡他莫拉菌,大肠埃希菌,克雷伯菌属,流感嗜血杆菌,其它革兰阴性菌分离菌株数,革兰阴性菌分离菌株总数,脆弱拟杆菌,其它拟杆菌属,拟杆菌属分离菌株总数,合计,J.J.A 54(S-B):72,79,2001,0,10,20,30,40,50,60,70,80,90,100,0.008,0.016,0.031,0.063,0.125,0.25,0.5,1,2,4,8,16,32,64,MIC,（,g/mL,）,（）,头孢,妥仑,（美爱克）,头孢克,洛,（希刻劳）,头孢地,尼,（,希福尼,）,氨苄青霉素,头,孢泊肟,（搏拿）,累积抑菌百分率,-,内酰胺类,抗生素对,795,株临床分,离耐药肺炎链球菌的,累积抑菌百分率,美爱克,对呼,吸道感染主要致病菌及其耐药菌株有强力的抗菌作用,3,、,对耐药菌高,敏感性,美爱克的总体特征,J.J.A 54(S-B):72,79,2001,0,10,20,30,40,50,60,70,80,90,100,0.002,0.004,0.008,0.016,0.031,0.063,0.125,0.25,0.5,1,2,4,8,16,32,64,MIC,（,g/mL,）,（）,羟氨苄青霉素,氨苄青霉素,累,积,抑菌,百,分,率,-,内酰胺类,抗,生素对,423,株临床分,离耐药流感嗜血杆菌的,累积抑菌百分率,3,、,对耐药,菌高敏感性,美爱克,对呼,吸道感染主要致病菌及其耐药菌株有强力的抗菌作用,美爱克的总体特征,头孢,妥仑,（美爱克）,头,孢泊肟,（搏拿）,头孢地,尼,（,希福尼,）,头孢克,洛,（希刻劳）,致病菌,患者数量,有效性,有效率,(%),有效,无效,肺炎链球菌（总体）,397,356,41,89.7,敏感肺炎链球菌,88,77,11,87.5,中介肺炎链球菌,133,117,16,88,耐药肺炎链球菌,101,91,10,90.1,未知,75,71,4,94.7,流感嗜血杆菌（总体）,393,355,38,90.3,不产酶敏感的流感嗜血杆菌,31,28,3,90.3,不产酶耐药的流感嗜血杆菌,107,99,8,92.5,产酶敏感的流感嗜血杆菌,8,8,0,100,产酶耐药的流感嗜血杆菌,1,1,0,100,未知,246,219,27,89,Mezzatesta ML,Gona F et al.J Chemother 2009,21:378-382,3,、,对耐,药菌高敏感性,头孢妥仑对肺炎链球菌、流感嗜血杆菌的治疗有效率,美爱克的总体特征,Organism,Periods,MIC90(g/ml),头孢妥仑,头孢克肟,头孢地尼,头孢呋辛,头孢克洛,头孢丙烯,阿莫西林,/,克拉维酸,氨苄西林,青霉素,左旋氧氟沙星,环丙沙星,克林霉素,肺炎链球菌,1995-1996(n=85),1999-2000(n=96),2003-2004(n=85),0.5,0.5,0.5,4,16,16,4,4,4,4,4,4,128,64,64,8,8,8,1,1,1,1,1,1,1,1,1,2,2,2,128,128,128,128,128,128,流感嗜血杆菌,1995-1996(n=85),1999-2000(n=85),2003-2004(n=85),0.03,0.25,0.25,0.25,1,1,1,16,16,4,64,64,16,128,128,16,128,128,2,32,16,2,64,8,4,64,16,0.03,0.03,0.03,1,2,1,16,32,16,金黄色葡萄链球菌（,MSSA,）,1995-1996(n=85),1999-2000(n=85),2003-2004(n=85),1,1,1,16,16,16,0.5,0.5,0.5,2,2,2,2,2,2,1,1,1,0.5,0.5,0.5,1,1,1,0.5,0.5,1,0.25,0.25,0.5,1,1,1,0.12,0.12,0.12,化脓性链球菌,1995-1996(n=85),1999-2000(n=85),2003-2004(n=85),0.008,0.008,0.008,0.12,0.12,0.12,0.016,0.016,0.016,0.016,0.016,0.016,0.12,0.12,0.12,0.03,0.03,0.03,0.016,0.016,0.016,0.016,0.016,0.016,0.016,0.016,0.016,1,0.5,1,0.12,0.12,16,0.06,0.06,0.12,卡它莫拉菌,1995-1996(n=85),1999-2000(n=85),2003-2004(n=85),0.25,0.25,0.5,0.25,0.25,0.25,0.25,0.12,0.25,2,2,4,4,4,4,8,8,16,0.25,0.25,0.5,2,2,2,8,8,16,0.06,0.06,0.06,0.06,0.06,0.06,8,16,16,4,、对,-,内酰胺酶稳定，不易耐药,多种抗生素对于呼吸系统感染分离致病菌,95-04,年,MIC90,值的变化,引自,:P2-019,，,10th WPCCID,，,2006,美爱克的总体特征,2001-2002,年,1993-1994,年,菌株,清除率,菌株,清除率,革兰阳性菌,45,97.8%,103,93.2%,革兰阴性菌,107,96.3%,189,94.2%,总计,152,96.7%,292,93.8%,国内两次临床试验细菌学清除率比较,4,、对,-,内酰胺酶稳定，不易耐药,Natl Med J China,March 10,2003,Vol 83,No.5,美爱克的总体特征,药物,头孢克洛,(,希刻劳,),头孢克肟,(,世福素,),头孢泊肟,(,搏拿,),头孢妥仑,(,美爱克,),左旋氧氟沙星,(,可乐必妥,),罗红,霉素,阿奇霉素,(,希舒美,),日本上市时间,82,年,1,月,87,年,9,月,89,年,12,月,94,年,6,月,93,年,12,月,91,年,3,月,00,年,6,月,总症数,(,来源,),17,589,(PMS),12,879,(PMS),12,517,(PMS),4,907,(PMS),16,161,(PMS),8,903,(PMS),1,886,(C/T),副作用例（发生率）,253,(1.44%),294,(2.28%),315,(2.52%),35,(0.71%),203,(1.26%),202,(2.27,),82,(4.35,),5,、高安全性，低副作用,引自日本上市药品说明书的口,服抗生素副作用发生率,美爱克的总体特征,呼吸系统感染：,急性支气管炎、慢性支气管炎、支气管扩张合并感染、肺炎、肺化脓症、其他慢性呼吸系统疾病继发的感染；,耳鼻喉感染,：咽喉炎、扁桃体炎、中耳炎、鼻旁窦炎；,泌尿系统感染：,肾盂肾炎、膀胱炎；,皮肤感染：,毛囊炎、疖、疖肿症、痈、传染性脓疱疮、丹毒、蜂窝织炎、淋巴管（结）炎、化脓性甲沟炎、瘭疽、皮下脓肿、汗腺炎、感染性粉瘤、慢性脓皮症；,眼科感染：,眼睑炎、麦粒肿、眼睑脓肿、泪囊炎、睑板腺炎；,妇科系统感染：,子宫附件炎、子宫内感染、前庭大腺炎；,口腔感染：,牙周炎、牙冠周炎、颌炎；,消化系统感染：,胆囊炎、胆管炎；,外科感染：,乳腺炎、肛门周围脓肿、外伤、手术创伤等浅表性继发感染。,葡萄球菌属、链球菌属、大肠埃希菌、枸橼酸杆菌属、克雷伯杆菌属、肠杆菌属、沙雷菌属、变形杆菌属（奇异变形杆菌、普通变形杆菌）、摩根杆菌属、普罗威登菌属、卡他莫拉菌、流感嗜血杆菌、拟杆菌属、消化链球菌属、痤疮丙酸杆菌中对本剂的敏感菌引起的下述感染症。,美爱克的临床应用,效能效果,美爱克的适应症包括,15,种菌属,引起的,42,种感染症,Clin J Clin Pharmacol 1998:15(1):1-8,感染,头孢妥仑匹酯,例数,有效率（,%,）,呼吸系统感染,83,92.8,（,77/83,）,泌尿系统感染,58,96.6,（,56/58,）,皮肤软组织感染,59,89.8,（,53/59,）,总计,200,93.0,（,186/200,）,美爱克的临床应用,1993-1994,年美爱克,II,期临床试验结果,病种分类,例数,痊愈,显效,进步,无效,痊愈率,有效率,上呼吸道感染,35,34,1,0,0,97.1%,100.0%,急性咽喉炎,18,17,1,0,0,急性扁桃体炎,17,17,0,0,0,下呼吸道感染,161,113,38,9,1,70.2%,93.8%,急性支气管炎,92,73,17,2,0,肺炎,51,34,13,3,1,其它下呼吸道感染,18,6,8,4,0,总计,196,147,39,9,1,75.0%,94.9%,Natl Med J China,March 10,2003,Vol 83,No.5,美爱克的临床应用,2001-2002,年美爱克上市后临床试验结果,Official PMS Document submitted to MOH Japan,97.4,100,100,92.4,92.1,92.6,99.1,98.1,100,100,100,97.6,100,100,100,97.6,97.4,97.6,0 20 40 60 80 100,（,%,）,167,305,126,11,2,19,630,68,63,131,1,18,66,103,112,15,22,1,098,咽喉炎,急性支气管炎,扁桃体炎,慢性支气管炎,慢性呼吸道疾病继发感染,肺炎,/,化脓症,合计,中耳炎,副鼻窦炎,合计,胆囊炎,/,胆管炎,妇产科感染症,外科感染症,泌尿系统感染症,皮肤感染症,眼部感染症,牙科感染症,合计,疾病种类及患者人数,有效率,美爱克的临床应用,临床效果,高敏感性,低耐药率,对,G,+,更强的抗菌活性,对呼吸系统感染主要致病菌更全面、更均衡的抗菌活性,美爱克较,其他三代头孢的优势,美爱克较其他口服三代头孢的优势,口服。常用量：一次,200mg,（,2,片），,1,日,2,次，,饭后服用,。,对本品成分有休克过往史的患者禁止,使用,用法,&,用量,Thank You!,明治医药有限公司,明天更健康,