比较天然表面活性剂肺泡表面活性物质（Alveofact）和珂立苏（Curosurf）治疗早产儿呼吸窘迫综合征临床疗效的观察性研究。
Observational study to compare the clinical efficacy of the natural surfactants Alveofact and Curosurf in the treatment of respiratory distress syndrome in premature infants.
作者信息
Proquitté Hans, Dushe Thekla, Hammer Hannes, Rüdiger Mario, Schmalisch Gerd, Wauer Roland R
机构信息
Clinic of Neonatology (Charité Campus Mitte), Humboldt-University Berlin, Berlin.
出版信息
Respir Med. 2007 Jan;101(1):169-76. doi: 10.1016/j.rmed.2006.03.033. Epub 2006 May 15.
INTRODUCTION
Natural surfactants have been shown to be superior to synthetic surfactants in the treatment of neonatal respiratory distress syndrome (RDS). In Germany, Alveofact (A) and Curosurf (C) are the most frequently used natural surfactant preparations. The aim of this retrospective, observational study was to compare the effects of A and C on gas exchange and outcome in premature infants.
METHODS
During a 5-year period in our neonatal intensive care unit (NICU), 187 premature infants were treated with surfactant, with 82 receiving A and 105 receiving C. We recorded F(I)O(2) and gas exchange (PaO(2)/F(I)O(2) ratio, PaCO(2), SaO(2)) during the first 72h after surfactant application and the incidence of outcome parameters at day 28 (bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH grade III or IV), patent ductus arteriosus (PDA), pneumothorax, necrotizing enterocolites (NEC) and death). The differences between the patient groups were assessed by ANOVA or the calculation of relative risks. Bonferroni correction was used for multiple comparisons.
RESULTS
There were no statistically significant differences between infants treated with A and C in mean gestational age (28.4 vs. 28.4 weeks), birth weight (1210 vs.1258 g) and time of first surfactant application (60 vs. 90 min postnatal). We observed no significant between group differences in course of F(I)O(2) and blood gases, or in incidence at day 28 of BPD (41.7% vs. 42.8%), IVH III/IV (18.3% vs. 14.3%), pneumothorax (9.8% vs. 4.8%), PDA (23.2% vs. 21.9%), PVL (7.3% vs. 9.5%) and death (17% vs. 17.1%). There were also no statistically significant differences in the subgroup of infants <28 weeks. The lower incidence of NEC in A compared with C (1.2% vs. 10.5%, P=0.01) was not statistically significant after Bonferroni correction.
CONCLUSION
Independent of gestational age no significant difference in the clinical efficacy of A and C was observed.
引言
在治疗新生儿呼吸窘迫综合征（RDS）方面，天然表面活性剂已被证明优于合成表面活性剂。在德国，肺泡表面活性物质（Alveofact，A）和固尔苏（Curosurf，C）是最常用的天然表面活性剂制剂。这项回顾性观察研究的目的是比较A和C对早产儿气体交换及预后的影响。
方法
在我们新生儿重症监护病房（NICU）的5年期间，187例早产儿接受了表面活性剂治疗，其中82例接受A治疗，105例接受C治疗。我们记录了应用表面活性剂后最初72小时内的吸入氧分数（F(I)O(2)）和气体交换情况（动脉血氧分压/吸入氧分数比值（PaO(2)/F(I)O(2)）、动脉血二氧化碳分压（PaCO(2)）、动脉血氧饱和度（SaO(2)））以及第28天的预后参数发生率（支气管肺发育不良（BPD）、脑室内出血（IVH III级或IV级）、动脉导管未闭（PDA）、气胸、坏死性小肠结肠炎（NEC）和死亡）。通过方差分析或相对风险计算评估患者组之间的差异。采用Bonferroni校正进行多重比较。
结果
接受A和C治疗的婴儿在平均胎龄（28.4周对28.4周）、出生体重（1210克对1258克）和首次应用表面活性剂的时间（出生后60分钟对90分钟）方面无统计学显著差异。我们观察到两组在F(I)O(2)和血气变化过程中，以及在第28天BPD发生率（41.7%对42.8%）、IVH III/IV级发生率（18.3%对14.3%）、气胸发生率（9.8%对4.8%）、PDA发生率（23.2%对21.9%）、脑室周围白质软化（PVL）发生率（7.3%对9.5%）和死亡率（17%对17.1%）方面均无显著组间差异。在孕周小于28周的婴儿亚组中也无统计学显著差异。A组NEC发生率低于C组（1.2%对10.5%，P = 0.01），但经Bonferroni校正后无统计学显著性。
结论
无论胎龄如何，未观察到A和C在临床疗效上有显著差异。
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