Division of Neonatal Medicine, Department of Paediatrics, University of Cape Town, Groote Schuur Hospital, Cape Town, 7925, South Africa.
J Trop Pediatr. 2020 Oct 1;66(5):534-541. doi: 10.1093/tropej/fmaa011.
Hyaline membrane disease contributes majorly to preterm mortality, particularly in the developing world. There are two animal-derived surfactants available in South Africa: poractant-alfa (120 mg/1.5 ml) and beractant (100 mg/4 ml). At equivalent doses, studies have shown no difference in mortality or morbidity, although there are limited data from the developing world. Both surfactants have been available for use at Groote Schuur Hospital in Cape Town but due to policy change, poractant-alfa was no longer available from November 2014. Due to weight-based dosing charts, infants who were given poractant-alfa received 20% higher dosages of phospholipid.
A before-and-after policy change non-experimental study was performed including infants from 2013 to 2015. Infants weighing <1500 g were recruited by identifying them from the surfactant register and further data were obtained from patient records. Data fields included infant weight, gestation, respiratory support and outcomes.
Two hundred and eight infants were included. One hundred and eight received beractant and 100 received poractant-alfa. The mean birth weight was 1031 g and gestational age 28.8 weeks. Seventy-nine percent of the infants received surfactant via the INSURE (intubation, surfactant and extubation) method. The combined outcome for death or bronchopulmonary dysplasia was 35.3% in the beractant group and 36% in the poractant-alfa group (p = 0.902). All secondary outcomes including neonatal morbidities, oxygen at 28 days or length of ventilation were not statistically significant.
There were no significant differences in outcomes between the two groups of infants who received different surfactants at the dosages used in our unit. This is one of the few studies of this type performed in a low- and middle-income countries.
肺透明膜病是导致早产儿死亡的主要原因,尤其是在发展中国家。南非目前有两种动物源性肺表面活性剂,分别为:固尔苏(120mg/1.5ml)和珂立苏(100mg/4ml)。虽然在发展中国家的数据有限,但等效剂量的研究表明,这两种肺表面活性剂在死亡率或发病率方面没有差异。固尔苏和珂立苏都在开普敦的格罗特舒尔医院使用,但由于政策改变,自 2014 年 11 月以来,固尔苏已不再供应。由于采用基于体重的给药图表,使用固尔苏的婴儿会接受 20%更高剂量的磷脂。
本研究为一项非实验性的政策改变前后研究,纳入了 2013 年至 2015 年的婴儿。通过从肺表面活性剂登记处识别婴儿,招募体重<1500g 的婴儿,进一步从患者记录中获得其他数据。数据字段包括婴儿体重、胎龄、呼吸支持和结局。
共纳入 208 名婴儿,其中 108 名接受珂立苏治疗,100 名接受固尔苏治疗。平均出生体重为 1031g,胎龄为 28.8 周。79%的婴儿通过 INSURE(插管、肺表面活性剂和拔管)方法接受肺表面活性剂治疗。在珂立苏组和固尔苏组中,死亡或支气管肺发育不良的联合结局发生率分别为 35.3%和 36%(p=0.902)。所有次要结局,包括新生儿发病率、28 天需氧和通气时间,均无统计学意义。
在我们单位使用的剂量下,接受不同肺表面活性剂的两组婴儿的结局没有显著差异。这是为数不多的在中低收入国家进行的此类研究之一。