注射用阿奇霉素产品介绍

注射用阿奇霉素AZITHROMYCIN FOR INJECTION,产品介绍,阿奇霉素概述,阿奇霉素（azithromycin）是新一代的大环内酯类抗生素，于1980年被发现，1981年推出。阿奇霉素是在第二代红霉素结构修饰后得到的一种广谱抗生素。其抗菌谱比红霉素更广，对流感嗜血杆菌、链球菌的作用比红霉素强4倍。对敏感革兰阳性菌、革兰阴性菌、衣原体、支原体等引起的呼吸、泌尿系统感染有很好的疗效。,阿奇霉素独特的结构式使得抗菌活性倍增,阿奇霉素 分子式：C38H72N2O12分子量：785.0,红霉素分子式 :C37H67NO13 分子量 733.93,阿奇霉素的药效学阿奇霉素抗菌活性强,阿奇霉素抗菌活性MIC 90,阿奇霉素的药效学（PD）,阿奇霉素对敏感致病菌具有较长的抗生素后效应,阿奇霉素抗菌谱广覆盖临床常见致病菌及非典型致病菌,出色的药代动力学保证阿奇霉素在感染部位的有效分布,特殊的靶向释药：吞噬细胞摄取靶向转移 感染部位药物释放，药物浓度增高,阿奇霉素组织内分布广泛，穿透性高吸收后快速分布到组织中，维持高而稳定的组织浓度组织内浓度可达同期血浓度10100倍,良好的组织渗透性和出色的半衰期 以感染为导向的“靶向”分布,阿奇霉素的药物清除,轻度肾功能不全者不需作剂量调整（肌酐清除率40ml/分钟）,阿奇霉素的临床应用,阿奇霉素在成人科室的应用,阿奇霉素治疗咽炎和扁桃体炎有效,Weippl, G. (1993). Multicentre comparison of azithromycin versus erythromycin in the treatment of paediatric pharyngitis or tonsillitis caused by group A streptococci. J Antimicrob Chemother 31 Suppl E: 95-101.,阿奇霉素是替代阿莫西林治疗中耳炎的首选,Arguedas, A., P. Emparanza, et al. (2005). A randomized, multicenter, double blind, double dummy trial of single dose azithromycin versus high dose amoxicillin for treatment of uncomplicated acute otitis media. Pediatr Infect Dis J 24(2): 153-161.,P=0.064,P=0.017,P=0.001,治疗急性鼻窦炎，阿奇霉素优于阿莫西林克拉维,Henry, D. C., E. Riffer, et al. (2003). Randomized double-blind study comparing 3- and 6-day regimens of azithromycin with a 10-day amoxicillin-clavulanate regimen for treatment of acute bacterial sinusitis. Antimicrob Agents Chemother 47(9): 2770-2774.,Ioannidis J P A et al. J. Antimicrob. Chemother. 2001;48:677-689, 2001 The British Society for Antimicrobial Chemotherapy,阿奇霉素治疗急性咽炎疗效确切,阿奇霉素治疗中耳炎疗效确切,Ioannidis J P A et al. J. Antimicrob. Chemother. 2001;48:677-689, 2001 The British Society for Antimicrobial Chemotherapy,阿奇霉素治疗鼻窦炎疗效确切,Ioannidis J P A et al. J. Antimicrob. Chemother. 2001;48:677-689, 2001 The British Society for Antimicrobial Chemotherapy,阿奇霉素对CAP疗效确切：各指南的评价,1 Clin Infect Dis. 2007;44:S27-S72 ；2 The Sanford guide to antimicrobial therapy.2008:34-35；3 ASCAP.2005:1-86 ；4 Eur Respir J 2005; 26: 11381180;5全科医生临床与教育。2007；5（5）：358-360,Contopoulos-Ioannidis D G et al. J. Antimicrob. Chemother. 2001;48:691-703, 2001 The British Society for Antimicrobial Chemotherapy,阿奇霉素显著降低CAP治疗失败率,阿奇霉素显著降低CAP患者死亡率,Asadi L, Sligl WI, Eurich DT, Macrolide-Based Regimens and Mortality in Hospitalized Patients With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis. Clin Infect Dis. 2012 May 31.,阿奇霉素显著降低CAP患者死亡率,Asadi L, Sligl WI, Eurich DT, Macrolide-Based Regimens and Mortality in Hospitalized Patients With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis. Clin Infect Dis. 2012 May 31.,阿奇霉素可降低院内获得性肺炎发生率,CONCLUSIONS: There was a trend towards reduced incidence of VAP in colonized azithromycin-treated patients. In addition, azithromycin significantly prevented VAP in those patients at high risk of rhamnolipid-dependent VAP, suggesting that virulence inhibition is a promising anti-microbial strategy.,美国感染病学会推荐阿奇霉素用于院内肺炎,Contopoulos-Ioannidis D G et al. J. Antimicrob. Chemother. 2001;48:691-703, 2001 The British Society for Antimicrobial Chemotherapy,阿奇霉素增加急性支气管炎治疗成功率,Contopoulos-Ioannidis D G et al. J. Antimicrob. Chemother. 2001;48:691-703, 2001 The British Society for Antimicrobial Chemotherapy,阿奇霉素增加慢性支气管炎急性发作的治疗成功率,阿奇霉素改善闭塞性支气管炎的肺通气功能,Verleden, G. M., B. M. Vanaudenaerde, et al. (2006). Azithromycin reduces airway neutrophilia and interleukin-8 in patients with bronchiolitis obliterans syndrome. Am J Respir Crit Care Med 174(5): 566-570.,阿奇霉素有效预防COPD急性发作,Albert, R. K., J. Connett, et al. (2011). Azithromycin for prevention of exacerbations of COPD. N Engl J Med 365(8): 689-698.,未发生急性加重的患者比例,阿奇霉素对COPD急性发作有效,GOLD推荐阿奇霉素用于COPD抗感染一线治疗,Usually initial empir -ical treatment is an aminopenicillin with or without clavulanic acid, macrolide, or tetracyline.,GOLD,阿奇霉素的临床应用,儿童肺炎发病率及病死率均较高，危害严重,Wardlaw T,et al. Pneumonia: the leading killer of children. Lancet 2006; 368:104850.Bradley HS,et al. The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. Clin Infect Dis. 2011 ;53(7):e25-76.,全球每年有超过两百万年龄5岁的儿童死于肺炎，约占该年龄段儿童死亡总数的1/5，是儿童死亡的主要原因1,阿奇霉素在儿科肺炎的应用国内外指南推荐,204例支原体肺炎患儿的临床研究,结论：阿奇霉素与红霉素的临床有效率(p0.05）有著性差异;咳嗽消失平均天数为6.8d、8.7d,发热平均消退为3.5d、6.0d阿奇霉素支原体肺炎有效性高于红霉素，退热快，副作用小阿奇霉素是治疗小儿支原体性肺炎一种安全、有效、简便的方法,资料来源：中华医院感染学杂志2006 年第16 卷第4 期,治疗组100例：用阿奇霉素10mg/kg/d，连续静滴35d对照组104例：用红霉素30mg/kg/d，静脉滴注714d,阿奇霉素在儿童上呼吸道感染指南中的地位,1 Pediatrics. 2004;113(5):1451-1465 2 Am Fam Physician 2007;76:1650-8, 1659-603 Pediatrics. 2001;108(3):798-8084 W.J. Fokkens, V.J. Lund, J. Mullol et al. Rhinology 2007;45(suppl 20): 1-139.5 Pediatrics 2006;117;1871-1878,阿奇霉素是儿科感染安全的用药选择,张春红,徐凤玲.注射用阿奇霉素对儿童的安全性和不良反应回顾性分析.中国医院药学杂志,2010,30(9):803805,一项病例数为12936例的大型回顾性分析显示：注射用阿奇霉素对儿童安全,注：1.儿童年龄分布在016岁之间2.该回顾性分析包含所有的阿奇霉素注射剂品牌3.百裕阿奇霉素杂质更少，质量更优，应用更安全,阿奇霉素在儿科应用的注意事项,儿童输液临床常常应用1.0mg/ml的浓度，输液时间大于1小时主要是因为高浓度（2.0mg/ml）的液体对患病儿童的血管刺激性较大，输液反应增加，儿童不易耐受,注射用阿奇霉素 简明处方资料,【成份】本品主要成份为阿奇霉素，辅料为苹果酸、甘露醇、磷酸氢二钠。【适应症】本品适用于敏感致病菌株所引起的下列感染：1.由肺炎衣原体、流感嗜血杆菌、嗜肺军团菌、卡他摩拉菌、肺炎支原体、金黄色葡萄球菌或肺炎链球菌引起的需要首先采取静脉滴注治疗的社区获得性肺炎。2.由沙眼衣原体、淋病奈瑟菌、人型支原体引起的需要首先采取静脉滴注治疗的盆腔炎。【规格】（1）0.25g（25万单位）；（2）0.5g（50万单位）【有效期】 24个月【禁忌】对阿奇霉素、红霉素或其他任何一种大环内酯类药物过敏者禁用。,注射用阿奇霉素 简明处方资料,【用法用量】用法：将本品用适量注射用水充分溶解，配制成0.1g/ml，再加入至250ml或500ml的0.9%氯化钠注射液或5%葡萄糖注射液中，最终阿奇