固尔苏对生命的尊重科室会

固尔苏对生命的尊重,目 录,固尔苏回忆录-时间的经典,2,固尔苏传奇录-疗效卓越,固尔苏启示录200mg的意义,3,PS的代谢,每小时II型上皮细胞代谢PS损失3.5-5.0mg,PS 在II型细胞内的合成与分泌 PS在肺液中的变化与分布,ELF（epithelial lining fluid):上皮细胞衬液，即肺液,II型上皮细胞 肺泡,50%,50%,1. Poets CF, Arning A, Bernhard W, et al. Active surfactant in pharyngeal aspirates of term neonates: lipid biochemistry and surface tension function. Eur J Clin Invest. 1997 Apr;27(4):293-8.2. Bernhard W, Mottaqhian J, Gebert A, et al. Commercial versus native surfactants. Surface activity, molecular components, and the effect of calcium. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1524-33.,固尔苏-唯一经过精制工艺的PS,固尔苏经历了一道独特的液-胶层析纯化，才保证了最终能达到80mg/ml的浓度在固尔苏的提取过程中，通过氯仿将中性脂类去除，进一步保证其较高的纯度，在固尔苏的提取过程中，经过高压过滤灭菌消毒，去除了可能导致危害的病原体,1. CUROSURF, Chiesi Inc.2. 珂立苏(注射用牛肺表面活性剂), 华润双鹤药业股份有限公司.,固尔苏的浓度高，所需液体量少,液体量增加对呼吸的影响 易造成反流喷溅 肺内液体量增加 影响肺通气与换气功能,1. CUROSURF Intratracheal Suspension prescribing information, Comerstone Therapeutics Inc.2. 珂立苏（注射用牛肺表面活性剂）说明书，华润双鹤药业股份有限公司。,固尔苏的磷脂和SP-B含量高于牛肺表面活性物质,1. CUROSURF Intratracheal Suspension prescribing information, Comerstone Therapeutics Inc.2. 珂立苏（注射用牛肺表面活性剂）说明书，华润双鹤药业股份有限公司。,早产儿RDS改善，取决与磷脂和SP-B的含量,不同药物使用前处理的时间,给药,复温,溶解,固尔苏1,珂立苏2,1. CUROSURF Intratracheal Suspension prescribing information, Comerstone Therapeutics Inc.2. 珂立苏（注射用牛肺表面活性剂）说明书，华润双鹤药业股份有限公司。,5分钟,单位磷脂计算，固尔苏减少约50的价格,1. CUROSURF, Chiesi Inc, 2014.2. 珂立苏(注射用牛肺表面活性剂), 华润双鹤药业股份有限公司, 2014.,小 结,固尔苏的优势： 原研进口猪肺PS，更接近人源PS 精制工艺保证了其较高的纯度与浓度 有效活性成分磷脂的含量高 使用时，不需溶解，不需要更换体位给药，所需时间短，使用更加便捷 所需治疗费用低,每毫克磷脂价格低于同类药品,权威指南推荐,2013欧洲共识指南：A级推荐：治疗RDS，首剂200 mg/kg的固尔苏优于牛肺制剂,Sweet DG, Carnielli V, Greisen G, et al. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants-2013 update. Neonatology. 2013;103(4):353-68.,目 录,固尔苏回忆录-时间的经典,2,固尔苏传奇录-疗效卓越,固尔苏启示录200mg的意义,固尔苏治疗后FiO2显著低于Beractant,*，P0.05;*, P0.01, Poractant alfa(固尔苏)与Beractant比较,Dizdar EA, Sari FN, Aydemir C, et al. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Am J Perinatol. 2012 Feb;29(2):95-100.,固尔苏显著缩短机械通气时间,Singh N, Hawley KL, Viswanathan K. Efficacy of porcine versus bovine surfactants for preterm newborns with respiratory distress syndrome: systematic review and meta-analysis. Pediatrics. 2011 Dec;128(6):e1588-95.,固尔苏相比同类药物显著缩短CPAP时间,赵冰,潘家华.不同肺表面活性物质治疗新生儿呼吸窘迫综合征疗效比较.中国新生儿科杂志.2014; 29(3):158-161.,*CPAP: Continuous Positive Airway Pressure, 持续气道正压通气,固尔苏显著缩短气管插管时间,Gharehbaghi MM, Sakha SH, Ghojazadeh M, et al. Complications among premature neonates treated with beractant and poractant alfa. Indian J Pediatr. 2010 Jul;77(7):751-4.,固尔苏比Beractant组拔管率高,Fujii AM,Patel SM,Allen R，et al. Poractant alfaandberactanttreatmentof verypremature infantswithrespiratory distress syndrome. J Perinatol.2010 Oct;30(10):665-70. Dizdar EA, Sari FN, Aydemir C, et al. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Am J Perinatol. 2012 Feb;29(2):95-100.,固尔苏比Beractant组重复给药率显著降低,Singh N, Hawley KL, Viswanathan K. Efficacy of porcine versus bovine surfactants for preterm newborns with respiratory distress syndrome: systematic review and meta-analysis. Pediatrics. 2011 Dec;128(6):e1588-95.,固尔苏比Beractant组所需重复剂量显著减少,Dizdar EA, Sari FN, Aydemir C, et al. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Am J Perinatol. 2012 Feb;29(2):95-100.,固尔苏显著降低早产儿RDS的死亡风险,Singh N, Hawley KL, Viswanathan K. Efficacy of porcine versus bovine surfactants for preterm newborns with respiratory distress syndrome: systematic review and meta-analysis. Pediatrics. 2011 Dec;128(6):e1588-95.,固尔苏治疗后气胸的发生率低,刘云, 李丽, 梁文英等.不同种类肺表面活性物质治疗新生儿呼吸窘迫综合征的疗效比较.中国当代儿科杂志.2012;14(4):253-255.,固尔苏治疗后肺出血的发生率低,Karadag N, Dilli D, Zenciroglu A, et al. Perfusion index variability in preterm infants treated with two different natural surfactants for respiratory distress syndrome. Am J Perinatol. 2014 Nov;31(11):1015-22.,小 结-固尔苏疗效卓越,降低机械通气和CPAP 降低吸氧浓度 缩短氧疗时间 缩短机械通气时间 缩短CPAP时间 缩短气管插管时间 提高气管拔管率 减少重复给药 降低重复给药率 减少重复给药次数,改善呼吸功能 改善血氧饱和度 降低死亡率、提高生存率 降低死亡风险 提高无病生存率 缩短住院时间使用固尔苏更加安全： 动脉导管未闭的发生率低 气胸的发生率低 肺出血的发生率低,目 录,固尔苏回忆录-时间的经典,2,固尔苏传奇录-疗效卓越,固尔苏启示录200mg的意义,外源性PS替代治疗显著提高PS在肺泡内的浓度,RDS早产儿给予200mg/kg外源性PS后，肺液PS浓度更接近正常新生儿,Hallman M. et al, The fate of exogenous surfactant in neonates with respiratory distress syndrome. Clin Pharmacokinet. 1994 Mar; 26(3):215-32,固尔苏人体药代动力学研究试验设计,研究背景：临床研究显示, 治疗新生儿呼吸窘迫综合症, 200mg/kg剂量优于100mg/kg. 但是为什么200mg/kg的剂量更优？两种剂量的药代动力学特征有什么不同却很少为人所知.研究结果：200mg/kg剂量半衰期显著延长，重复给药显著减少，氧合指数显著改善.,Cogo PE, Facco M, Simonato M, et al. Dosing of porcine surfactant: effect on kinetics and gas exchange in respiratory distress syndrome. Pediatrics. 2009;124(5):e950-7.,随机,200mg/kg的剂量能显著改善氧合、减少所需重复剂量,Cogo PE, Facco M, Simonato M, et al. Dosing of porcine surfactant: effect on kinetics and gas exchange in respiratory distress syndrome. Pediatrics. 2009;124(5):e950-7.,200mg/kg比100mg/kg肺内半衰期显著延长,Cogo PE, Facco M, Simonato M, et al. Dosing of porcine surfactant: effect on kinetics and gas exchange in respiratory distress syndrome. Pediatrics. 2009;124(5):e950-7.,研究设计,随机,主要观察指标：利用单因素、多元Logistic回归分析与需要重复给药相关的临床指标和外源表面活性剂药代动力学指标研究结果：需要更多表面活性剂剂量的早产儿肺内DSPC的半衰期显著缩短；较低出生体重、100mg/kg的剂量、较低放射学得分和较短DSPC半衰期与重复给药风险相关,Cogo PE, Facco M, Simonato M,et al. Pharmacokinetics and clinical predictors of surfactant redosing in respiratory distress syndrome. Intensive Care Med. 2011 Mar;37(3):510-7.,100mg/kg首剂和较短DSPC半衰期预示重复给药,Logistic回归模型较好地阐明了与RDS早产儿重复给药相关的因素,Cogo PE, Facco M, Simonato M,et al. Pharmacokinetics and clinical predictors of surfactant redosing in respiratory distress syndrome. Intensive Care Med. 2011 Mar;37(3):510-7.,固尔苏与牛肺制剂对照汇总分析研究设计,Singh N, Hawley KL, Viswanathan K. Efficacy of porcine versus bovine surfactants for preterm newborns with respiratory distress syndrome: systematic review and meta-analysis. Pediatric