Courtney S E, Long W, McMillan D, Walter D, Thompson T, Sauve R, Conway B, Bard H
Department of Pediatrics, Children's Medical Center, Dayton, Ohio, USA.
J Pediatr. 1995 May;126(5 Pt 2):S43-52. doi: 10.1016/s0022-3476(95)70007-2.
Synthetic surfactant has been shown to reduce neonatal and 1-year mortality and neonatal morbidity in infants with respiratory distress syndrome. However, less is known about the effects of synthetic surfactant on developmental outcome and long-term morbidity. Four multicenter, randomized, placebo-controlled trials of synthetic surfactant administered as rescue therapy were conducted in the United States and Canada, with a total enrollment of 2224 patients. Double-blind developmental evaluations of survivors were conducted at 1 year of age (adjusted for prematurity) in all four trials. Of the 1802 patients enrolled in the placebo-controlled rescue trials who survived to 1 year, 1540 (85%) completed the 1-year follow-up evaluation. Height, weight, and head circumference measurements were not different in the treatment and control groups. Mean and median Bayley Scores of Infant Development for both the Mental Development Index and the Psychomotor Development Index were also equivalent. The incidence of impairments was not different in the two groups (mild to moderate impairment, 12% (92 of 745) for the air placebo group vs 11% (86 of 771) for the synthetic surfactant group; severe impairment, 15% (114 of 745) for the air placebo group vs 13% (102 of 771) for the synthetic surfactant group). No differences in rates of retinopathy of prematurity or hearing impairment were found in the treatment groups. The need for surgery after day 28 of life (relative risk, 0.779; 95% confidence interval, 0.665, 0.927) and the need for respiratory support at 1 year (relative risk, 0.525; 95% confidence intervals, 0.303, 0.911) were both reduced in the synthetic surfactant group. These results indicate that developmental outcome at 1 year of age is at least as good among infants with respiratory distress syndrome who received rescue therapy with synthetic surfactant as it is in infants who received air placebo; the results also indicate that the incidence of long-term morbidity is reduced.
合成表面活性剂已被证明可降低呼吸窘迫综合征婴儿的新生儿死亡率和1岁时的死亡率以及新生儿发病率。然而，关于合成表面活性剂对发育结局和长期发病率的影响，人们了解得较少。在美国和加拿大进行了四项多中心、随机、安慰剂对照试验，将合成表面活性剂作为抢救治疗药物，共纳入2224例患者。在所有四项试验中，对幸存者在1岁时（根据早产情况进行调整）进行了双盲发育评估。在安慰剂对照的抢救试验中存活至1岁的1802例患者中，1540例（85%）完成了1年的随访评估。治疗组和对照组的身高、体重和头围测量结果无差异。心理发育指数和心理运动发育指数的贝利婴儿发育平均得分和中位数得分也相当。两组的损伤发生率无差异（轻度至中度损伤，空气安慰剂组为12%（745例中的92例），合成表面活性剂组为11%（771例中的86例）；重度损伤，空气安慰剂组为15%（745例中的114例），合成表面活性剂组为13%（771例中的102例））。治疗组之间在早产儿视网膜病变或听力损伤发生率方面未发现差异。合成表面活性剂组在出生后28天之后的手术需求（相对风险，0.779；95%置信区间，0.665，0.927）和1岁时的呼吸支持需求（相对风险，0.525；95%置信区间，0.303，0.9）均有所降低。这些结果表明，接受合成表面活性剂抢救治疗的呼吸窘迫综合征婴儿在1岁时的发育结局至少与接受空气安慰剂的婴儿一样好；结果还表明，长期发病率有所降低。
