Wauer R R, Schmalisch G, Rogalski M
Abteilung Neonatologie, Universitätsklinikum Charité, Humboldt-Universität zu Berlin.
Klin Padiatr. 1996 Nov-Dec;208(6):355-65. doi: 10.1055/s-2008-1046497.
After registration of the bovine Surfactant Alveofact (Fa. Thomae) for treatment of neonatal respiratory distress syndrome (RDS) an observational study was performed in 47 german neonatal departments to register indication, effectivity, mode of administration and unexpected side effects.
680 ventilated preterm infants (gestational weeks 29.5 +/- 2.9; birth weight 1359 +/- 507 g) were enrolled in an uncontrolled clinical study with study-protocol, prospectively defined outcomes and covariates, manual of operation, central control system, biometrical control.
Surfactant was applicated at a postnatal age of 2 hours 56 minutes (median). Only 2.9% of newborn infants got the first surfactant doses < 6 min postnatally, 19.4% between 6 ... 60 min and 77.7% > 60 min postnatally. Following 1338 instillations in 76% an improved lung function, in 21% no change and in 3% a worsening was observed. During the study the total dose of surfactant increased. Safety considerations determined by the rate of pulmonary and extrapulmonary complications were similar to data of the literature: pneumothorax 12%, pulmonary interstitial emphysema 11.6%, secondary pneumonia 20.4%, broncho-pulmonary dysplasia 27%, pulmonary hemorrhage 2.1%, peri/intraventricular hemorrhage (degree III/IV) 27.9%, ductus arteriosus persistens 24.4%, sepsis/meningitis 12.4%. During the study the mortality reduces from 31% (first period) to 18% (third period) the mean was 20%. In 44 infants (6.5%) a disturbed ventilation (airway obstruction, overdystension of pulmonary areas, atelectasis) after surfactant administration was observed.
In RDS the surfactant Alveofact is preferably used therapeutically (rescue mode), it is effective but not free of risk. Its administration needs for a clear indication. New unknown side effects of Alveofact were not observed.
在牛肺表面活性物质Alveofact（托马公司生产）注册用于治疗新生儿呼吸窘迫综合征（RDS）后，在德国47个新生儿科室开展了一项观察性研究，以记录其适应证、有效性、给药方式及意外副作用。
680例机械通气的早产儿（孕周29.5±2.9周；出生体重1359±507克）被纳入一项非对照临床研究，该研究有研究方案、前瞻性定义的结局和协变量、操作手册、中央控制系统及生物统计学对照。
肺表面活性物质给药的中位生后年龄为2小时56分钟。仅2.9%的新生儿在生后<6分钟接受了首剂肺表面活性物质，19.4%在生后6至60分钟接受，77.7%在生后>60分钟接受。在76%的患儿进行1338次滴注后观察到肺功能改善，21%无变化，3%恶化。研究期间肺表面活性物质的总剂量增加。由肺部和肺外并发症发生率所确定的安全性考量与文献数据相似：气胸12%，肺间质气肿11.6%，继发性肺炎20.4%，支气管肺发育不良27%，肺出血2.1%，脑室周围/脑室内出血（III/IV级）27.9%，动脉导管未闭24.4%，败血症/脑膜炎12.4%。研究期间死亡率从31%（第一阶段）降至18%（第三阶段），平均为20%。在44例（6.5%）婴儿中观察到肺表面活性物质给药后通气障碍（气道梗阻、肺区过度扩张、肺不张）。
在RDS中，肺表面活性物质Alveofact最好用于治疗（抢救模式），它有效但并非无风险。其给药需要明确的适应证。未观察到Alveofact新的未知副作用。
