Herting E, Tubman R, Halliday H L, Harms K, Speer C P, Curstedt T, Robertson B
Universitäts-Kinderklinik, Göttingen.
Monatsschr Kinderheilkd. 1993 Sep;141(9):721-7.
Doses between 20 and 200 mg/kg body weight (bw) of different surfactant preparations have been recommended in clinical trials for the treatment of neonatal RDS; an optimal dose regimen of surfactant replacement therapy has not yet been defined. Aim of the present pilot study was the evaluation of pulmonary gas exchange in infants with severe RDS following the application of either a high (200 mg/kg bw) or a low (100 mg/kg bw) dose of a natural porcine surfactant (Curosurf).
15 neonates were randomized to a high dose regimen, 17 infants to a low dose of surfactant. Apart from a lower 1 minute Apgar in the 100 mg/kg bw group, birth weight, gestational age, sex, 5 minute-Apgar and disease severity (arterial to alveolar oxygenation ratio (a/A-ratio): 0.10 +/- 0.03 [high dose], 0.11 +/- 0.06 [low dose], mean +/- SD) were well matched in both groups.
Following surfactant instillation there was a rapid improvement in oxygenation in both groups. The a/A-ratio was slightly higher in the 200 mg/kg bw group during the first 12 hours following surfactant replacement, but statistically this was significantly higher only 4 hours after treatment (0.38 +/- 0.11 vs. 0.24 +/- 0.13, mean +/- SD, p < 0.05).
The dose of 100 mg/kg bw Curosurf resulted in a rapid improvement in oxygenation and ventilatory requirements; only during the first hours following surfactant replacement there was a slight further improvement with the higher dose of 200 mg/kg bw. The impact of different dose regimens on outcome parameters still has to be defined by a larger clinical trial.
在治疗新生儿呼吸窘迫综合征(RDS)的临床试验中,已推荐使用20至200毫克/千克体重(bw)的不同表面活性剂制剂;表面活性剂替代疗法的最佳剂量方案尚未确定。本试点研究的目的是评估应用高剂量(200毫克/千克bw)或低剂量(100毫克/千克bw)天然猪表面活性剂(珂立苏)后,重症RDS婴儿的肺气体交换情况。
15例新生儿被随机分配至高剂量方案组,17例婴儿被分配至低剂量表面活性剂组。除了100毫克/千克bw组的1分钟阿氏评分较低外,两组在出生体重、胎龄、性别、5分钟阿氏评分和疾病严重程度(动脉血氧分压与肺泡血氧分压比值(a/A比值):0.10±0.03 [高剂量],0.11±0.06 [低剂量],均值±标准差)方面匹配良好。
两组在滴入表面活性剂后氧合情况均迅速改善。在表面活性剂替代后的前12小时内,200毫克/千克bw组的a/A比值略高,但仅在治疗后4小时,该值在统计学上显著更高(0.38±0.11对0.24±0.13,均值±标准差,p<0.05)。
100毫克/千克bw的珂立苏剂量可使氧合和通气需求迅速改善;仅在表面活性剂替代后的最初几小时内,200毫克/千克bw的较高剂量有轻微进一步改善。不同剂量方案对结局参数的影响仍需通过更大规模的临床试验来确定。