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Surfaxin：治疗早产儿呼吸窘迫综合（RDS） 2012年3月6日，Discovery Laboratories Inc公司的Surfaxin(通用名：lucinactant)获得美国食品药品管理局(FDA)批准，治疗早产儿呼吸窘迫综合征。 Surfaxin是在美国被批准治疗早产儿呼吸窘迫综合（RDS）的第五个药物。FDA批准的其它表面活性剂包括Survanta (贝拉康坦[beractant])， Curosurf (poractant alpha)， Infasurf (calfactant)， 和不再上市的Exosurf (棕榈酸考福西利[colfosceril palmitate])。 适应症和用途：SURFAXIN 适用于为在RDS高危早产婴儿时呼吸窘迫综合症(RDS)的预防。 SURFAXIN (lucinactant)气管内悬液 剂量和给药方法： （1）SURFAXIN的推荐剂量是通过气管内给药每kg出生体重给予5.8 mL （2）SURFAXIN可在生命的头48小时给药直至4剂。 （3）给药频数不应超过每6小时1次。 剂型和规格： 气管内悬液：8.5 mL 悬液在玻璃小瓶内。每mL含30 mg磷脂(22.50 mg二棕榈酰磷脂酰胆碱和7.50 mg棕榈油酰甘油磷酸甘油， 钠盐)， 4.05 mg棕榈酸，和0.862 mg 西那普肽。 禁忌症： 无。 警告和注意事项： （1）肺顺应性中急性变化： 婴儿接受SURFAXIN应接受经常临床评估以便氧和通气支持可被修饰对呼吸状态变化的反应。 （2）给药-相关不良反应：如不良反应包括心动过缓，血氧把饱和度下降，SURFAXIN给药期间SURFAXIN的反流进入气管插管(ETT)，和发生 气道/ETT阻塞，应中断给药和评估婴儿临床情况和稳定化。吸出ETT或如气道阻塞持续或严重可能需要再插管。 （3）在有急性呼吸窘迫综合症(ARDS)成年中严重不良反应增加：有ARDS成年接受lucinactant通过段支气管肺泡灌流曾增加死亡的发生率，多器官衰竭，败血症，缺氧性脑病，肾衰，缺氧，气胸，低血压，和肺栓塞。在ARDS中不适用SURFAXIN。 不良反应： 伴随使用SURFAXIN最常见不良反应是气管插管内回流，苍白，气管插管阻塞，和需要中断给药。
Discovery Lab’s RDS drug Surfaxin approved in USA Discovery Laboratories was boosted by the news that the U.S. FDA finally approved its Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants with high risk of the breathing disorder. Respiratory distress syndrome (RDS) is a potentially fatal breathing disorder that affects premature babies who are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. It is estimated that around 90,000 premature infants in the USA are treated annually with currently available animal-derived surfactants along with mechanical ventilation to help them breathing. Discovery Labs’ Surfaxin is the fifth agent cleared by FDA to treat RDS in premature infants. The other approved surfactants include Survanta (beractant), Curosurf (poractant alpha), Infasurf (calfactant), and Exosurf (colfosceril palmitate). Discovery Labs hopes its Surfaxin, as the first approved synthetic, peptide-containing surfactant, can replace all these conventional medicines in preventing RDS. Results from a multinational phase 3 clinical trial has demonstrated the safety and efficacy of Surfaxin for the prevention of RDS in premature infants. In the late-stage study, nearly 1,300 premature infants received either Surfaxin, the no-longer marketed Exosurf or Abbott Laboratories’ Survanta within 30 minutes of birth. Surfaxin demonstrated significant improvement in both RDS at 24 hours after birth and RDS-related mortality through two weeks, when compared with Exosurf, which was marketed by GSK previously. Discovery chief executive Thomas Amick was very optimistic on the approval of Surfaxin. He said the approval of Surfaxin is “an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS”. Discovery Labs said the company anticipates that SURFAXIN will be commercially available in the U.S. late this year. |
