Halliday H L
Regional Neonatal Unit, Royal Maternity Hospital, Belfast, Northern Ireland.
Drugs. 1996 Feb;51(2):226-37. doi: 10.2165/00003495-199651020-00004.
This review examines the 11 randomised clinical trials that have compared different surfactant preparations. Seven trials, enrolling 2488 infants with respiratory distress syndrome (RDS), compared the natural surfactant beractant (Survanta) with the synthetic surfactant colfosceril palmitate (Exosurf Neonatal). Infants treated with beractant had lower oxygen requirements for at least 3 days than those treated with colfosceril palmitate. The infants treated with beractant also had lower risks of neonatal mortality [odds ratio (OR) 0.81; 95% confidence interval (CI) 0.65 to 1.01], retinopathy of prematurity (OR 0.81; 95% CI 0.66 to 0.99), and the combined endpoint of death or bronchopulmonary dysplasia (OR 0.86; 95% CI 0.75 to 0.99), compared with those treated with colfosceril palmitate. Calf lung surfactant extract (CLSE; Infasurf), another natural surfactant, has been compared with colfosceril palmitate in 2 studies: in one as prophylaxis and in the other as rescue therapy. Similar, although nonsignificant, advantages were found for the natural surfactant compared with the synthetic surfactant. In 6 of these 9 trials there was a significant reduction in the odds of pulmonary air leaks (OR 0.53; 95% CI 0.41 to 0.64) for infants treated with natural compared with synthetic surfactants. In 7 trials (3554 infants) comparing natural and synthetic surfactants to treat RDS (6 comparing beractant and colfosceril palmitate, and one CLSE and colfosceril palmitate), there was a significantly reduced risk of neonatal mortality (OR 0.80; 95% CI 0.66 to 0.97) with natural compared with synthetic surfactant treatment. In 2 further trials, different natural surfactant preparations have been compared. Reduced oxygen needs for 24 hours after treatment were found for CLSE and Curosurf (porcine-derived lung surfactant, PLS) when each was compared with beractant. Apparent longer term benefits from these surfactants were not statistically proven. Further trials are needed to be certain of the differences between the various surfactant preparations.
本综述考察了11项比较不同表面活性剂制剂的随机临床试验。7项试验纳入了2488例患有呼吸窘迫综合征（RDS）的婴儿，比较了天然表面活性剂贝拉克坦（固尔苏）与合成表面活性剂棕榈酸考福司坦（爱索美拉）。接受贝拉克坦治疗的婴儿至少3天内的氧气需求量低于接受棕榈酸考福司坦治疗的婴儿。与接受棕榈酸考福司坦治疗的婴儿相比，接受贝拉克坦治疗的婴儿发生新生儿死亡的风险也更低[比值比（OR）0.81；95%置信区间（CI）0.65至1.01]、早产儿视网膜病变（OR 0.81；95%CI 0.66至0.99）以及死亡或支气管肺发育不良的联合终点事件（OR 0.86；95%CI 0.75至0.99）。另一种天然表面活性剂小牛肺表面活性剂提取物（CLSE；因法斯）已在2项研究中与棕榈酸考福司坦进行了比较：一项作为预防用药，另一项作为挽救治疗。与合成表面活性剂相比，天然表面活性剂显示出类似但不显著的优势。在这9项试验中的6项试验中，接受天然表面活性剂治疗的婴儿发生肺漏气的几率显著降低（OR 0.53；95%CI 0.41至0.64），而接受合成表面活性剂治疗的婴儿则不然。在7项比较天然和合成表面活性剂治疗RDS的试验（3554例婴儿）中（6项比较贝拉克坦和棕榈酸考福司坦，1项比较CLSE和棕榈酸考福司坦），与合成表面活性剂治疗相比，天然表面活性剂治疗显著降低了新生儿死亡风险（OR 0.80；95%CI 0.66至0.97）。在另外2项试验中，比较了不同的天然表面活性剂制剂。当将CLSE和珂立苏（猪源性肺表面活性剂，PLS）分别与贝拉克坦进行比较时，发现治疗后24小时内氧气需求量有所降低。这些表面活性剂的长期益处尚未得到统计学证实。需要进一步试验以确定各种表面活性剂制剂之间的差异。
