Kukkonen A K, Virtanen M, Järvenpää A L, Pokela M L, Ikonen S, Fellman V
Hospital for Children and Adolescents, Helsinki University Central Hospital, Finland.
Acta Paediatr. 2000 May;89(5):556-61. doi: 10.1080/080352500750027853.
The efficacy of a natural porcine surfactant and a synthetic surfactant were compared in a randomized trial. In three neonatal intensive care units, 228 neonates with respiratory distress and a ratio of arterial to alveolar partial pressure of oxygen <0.22 were randomly assigned to receive either Curosurf 100 mgkg-1 or Exosurf Neonatal 5 ml.kg-1. After Curosurf, the fraction of inspired oxygen was lower from 15 min (0.45 +/- 0.22 vs 0.70 +/- 0.22, p = 0.0001) to 6 h (0.48 +/- 0.26 vs 0.64 +/- 0.23, p = 0.0001) and the mean airway pressure was lower at 1 h (8.3 +/- 3.2 mm H20 vs 9.4 +/- 3.1 mm H20, p = 0.01). Thereafter the respiratory parameters were similar. The duration of mechanical ventilation (median 6 vs 5 d) and the duration of oxygen supplementation (median 5 vs 4 d) were similar for Curosurf and Exosurf. After Curosurf, C-reactive protein value over 40 mg l-1 occurred in 45% (vs 12%; RR 3.62, 95%CI 2.12-6.17, p = 0.001), leukopenia in 52% (vs 28%; RR 1.85, 95% CI 1.31-2.61, p = 0.001) and bacteraemia in 11% (vs 4%; RR 3.17, 95% CI 1.05-9.52, p < 0.05). We conclude that when given as rescue therapy Curosurf had no advantage compared with Exosurf in addition to the more effective initial response. Curosurf may increase the risk of infection.
在一项随机试验中比较了天然猪肺表面活性物质和合成肺表面活性物质的疗效。在三个新生儿重症监护病房，将228例患有呼吸窘迫且动脉血氧分压与肺泡血氧分压之比<0.22的新生儿随机分配接受固尔苏100mg/kg或新固尔苏5ml/kg。给予固尔苏后，从15分钟（0.45±0.22对0.70±0.22，p = 0.0001）至6小时（0.48±0.26对0.64±0.23，p = 0.0001）吸入氧分数较低，且1小时时平均气道压较低（8.3±3.2mmH₂O对9.4±3.1mmH₂O，p = 0.01）。此后呼吸参数相似。固尔苏和新固尔苏的机械通气时间（中位数6天对5天）和氧疗时间（中位数5天对4天）相似。给予固尔苏后，45%出现C反应蛋白值超过40mg/L（对12%；RR 3.62，95%CI 2.12 - 6.17，p = 0.001），52%出现白细胞减少（对28%；RR 1.85，95%CI 1.31 - 2.61，p = 0.001），11%出现菌血症（对4%；RR 3.17，95%CI 1.05 - 9.52，p < 0.05）。我们得出结论，作为抢救治疗时，除了初始反应更有效外，固尔苏与新固尔苏相比并无优势。固尔苏可能会增加感染风险。
