Rollins M, Jenkins J, Tubman R, Corkey C, Wilson D
Department of Paediatrics, Waveney Hospital, Ballymena, N. Ireland.
J Perinat Med. 1993;21(5):341-7. doi: 10.1515/jpme.1993.21.5.341.
The clinical responses to both natural and synthetic surfactants were observed in two District General Hospital Neonatal Units who were centrally randomised as part of two separate multicentre trials (OSIRIS and Curosurf 4). Forty five infants were enrolled consecutively in the OSIRIS trial using synthetic surfactant (Exosurf), while 21 infants were subsequently enrolled in the Curosurf 4 trial using natural surfactant (Curosurf). There were no significant differences between the groups for mean birth weight, gestational age, inspired oxygen (FiO2), or arterial: alveolar oxygen ratio (a/A) prior to surfactant administration. Oxygen requirements fell significantly more rapidly within the first 24 hours for patients treated with Curosurf compared to Exosurf (p < 0.001). Mean duration of > 40% oxygen requirement was significantly shorter in the Curosurf group (2.6 days) compared to 8.0 days in the Exosurf group (p < 0.01). Mean duration of oxygen therapy was also significantly shorter in the Curosurf group (10.2 days) compared to 17.1 days in the Exosurf group (p < 0.05). Ten infants (24%) in the Exosurf group developed intraventricular haemorrhage (IVH) compared to none in the Curosurf group (p < 0.05). As oxygen requirements appear to decrease more rapidly following administration of Curosurf compared to Exosurf a large prospective randomized multicentre trial needs to be performed to compare the effects of these surfactants on both short and long-term outcome.
在两家地区综合医院的新生儿病房观察了天然和合成表面活性剂的临床反应,这两家医院作为两项独立多中心试验(OSIRIS和珂立苏4)的一部分进行了集中随机分组。在OSIRIS试验中,连续纳入45例使用合成表面活性剂(固尔苏)的婴儿,随后在珂立苏4试验中纳入21例使用天然表面活性剂(珂立苏)的婴儿。在给予表面活性剂之前,两组在平均出生体重、胎龄、吸入氧浓度(FiO2)或动脉血氧分压与肺泡血氧分压比值(a/A)方面无显著差异。与使用固尔苏治疗的患者相比,使用珂立苏治疗的患者在最初24小时内氧需求下降得明显更快(p<0.001)。珂立苏组平均需氧量>40%的持续时间(2.6天)明显短于固尔苏组的8.0天(p<0.01)。珂立苏组的平均氧疗持续时间(10.2天)也明显短于固尔苏组的17.1天(p<0.05)。固尔苏组有10例婴儿(24%)发生脑室内出血(IVH),而珂立苏组无1例发生(p<0.05)。由于与固尔苏相比,使用珂立苏后氧需求似乎下降得更快,因此需要进行一项大型前瞻性随机多中心试验,以比较这些表面活性剂对短期和长期结局的影响。