de Winter J P, Egberts J, de Kleine M J, van Bel F, Wijnands J B, Guit G L
Afd. Kindergeneeskunde, Academisch Ziekenhuis, Leiden.
Ned Tijdschr Geneeskd. 1992 Oct 10;136(41):2018-24.
To study the effects of administration of surfactant immediately after birth (prophylactic) or after 6 hr (therapeutic) to 81 Dutch preterm infants from a multicentre trial.
University Hospital Leiden and Sint Joseph Hospital, Veldhoven.
A randomized controlled trial with stratification for biochemical lung (im)maturity. The aims of the study were (I): to improve the TcPO2/FiO2 ratio by 40% and (2) to prevent the respiratory distress syndrome by 50% at 6 hours after birth. The secondary goal was to compare effects of prophylactic versus therapeutic use of exogenous surfactant (from 6 hours onwards) in surfactant-deficient infants.
The entrance criteria of the study were: (I) inborn children with a gestational age between 26 and 30 weeks, (2) elective intubation and (3) sampling of bronchotracheal or gastric aspirate. After randomization the children received surfactant within 10 minutes after birth prophylactically (n = 42) or 6 hours after birth if they needed more than 60% oxygen (13 of 39 control infants). A second dose of surfactant was given if, at 6 hours after the first dose, the FiO2 was still high (> or = 0.6).
We used a natural porcine surfactant preparation (Curosurf) in a dose of 200 mg/kg given through the endotracheal tube.
The mean gestational age of the 81 infants was 28.2 weeks. The TcPO2/FiO2 ratios increased in the prophylactic group compared with the controls (38 versus 30 kPa; p < 0.05). RDS occurred less often and less severely in the prophylactic group (p < 0.05). Neonatal mortality was lower in the prophylactically treated infants (3/42) than in the control group (10/39; p < 0.05). Compared with the control infants with immature lungs, the immature prophylactically treated infants had six hours after birth higher TcPO2/FiO2 ratios (35 vs 13 kPa; p < 0.001), a 35% reduction of the incidence of RDS with a significant reduction of its severity (p < 0.05), and significantly lower mean airway pressures (0.87 versus 1.24 kPa; p < 0.005). The surfactant given 6 hours after birth to the immature controls resulted in an immediate improvement of the oxygenation. Nevertheless, these infants spent more time on the respirator and needed extra oxygen for longer periods than the immature infants prophylactically treated (p < 0.05).
Surfactant, given either prophylactically or therapeutically, results in clinical improvement of children with biochemically immature lungs. A prophylactic treatment, moreover, results in reduced incidence and severity of RDS, in a significant shortening of the time spent on the respirator and in reduced need of extra oxygen compared with therapeutic treatment. We recommend to give surfactant prophylactically or at the first signs of RDS.
在一项多中心试验中，研究对81名荷兰早产儿出生后立即（预防性）或6小时后（治疗性）给予表面活性剂的效果。
莱顿大学医学中心和费尔德霍芬的圣约瑟夫医院。
一项针对生化性肺（未）成熟进行分层的随机对照试验。该研究的目的为：（1）使TcPO2/FiO2比值提高40%；（2）在出生后6小时预防呼吸窘迫综合征的发生率达50%。次要目标是比较表面活性物质缺乏婴儿预防性与治疗性使用外源性表面活性剂（出生6小时后开始）的效果。
该研究的入选标准为：（1）胎龄26至30周的足月儿；（2）择期插管；（3）支气管气管或胃吸出物采样。随机分组后，婴儿在出生后10分钟内预防性给予表面活性剂（n = 42），或者出生6小时后若需要超过60%的氧气则给予表面活性剂（39名对照婴儿中的13名）。如果在首剂给药6小时后FiO2仍很高（≥0.6），则给予第二剂表面活性剂。
我们使用天然猪肺表面活性剂制剂（固尔苏），剂量为200mg/kg，通过气管内导管给药。
81名婴儿的平均胎龄为28.2周。与对照组相比，预防性给药组的TcPO2/FiO2比值升高（38对30kPa；p<0.05）。预防性给药组呼吸窘迫综合征的发生率和严重程度更低（p<0.05）。预防性治疗的婴儿的新生儿死亡率低于对照组（3/42比10/39；p<0.05）。与肺不成熟的对照婴儿相比，肺不成熟的预防性治疗婴儿在出生6小时后的TcPO2/FiO2比值更高（35对13kPa；p<0.001），呼吸窘迫综合征的发生率降低35%，严重程度显著降低（p<0.05），平均气道压力显著更低（0.87对1.24kPa；p<0.005）。出生6小时后给予肺不成熟的对照组表面活性剂可使氧合立即改善。然而，这些婴儿使用呼吸机的时间比预防性治疗的肺不成熟婴儿更长，需要额外吸氧的时间也更长（p<0.05）。
预防性或治疗性给予表面活性剂均可使生化性肺不成熟的患儿临床症状改善。此外，与治疗性给药相比，预防性治疗可降低呼吸窘迫综合征的发生率和严重程度，显著缩短使用呼吸机的时间，并减少额外吸氧的需求。我们建议预防性给予表面活性剂或在呼吸窘迫综合征的首个迹象出现时给药。
