Halliday Henry L
Regional Neonatal Unit, Royal-Jubilee Maternity Service, Royal Maternity Hospital and Department of Child Health, Queen's University Belfast, Northern Ireland, UK.
Biol Neonate. 2006;89(4):323-9. doi: 10.1159/000092869. Epub 2006 Jun 1.
To search for recent clinical trials of neonatal surfactant treatment and report their findings.
Recent was defined as published between 2000 and 2005. An online search on PubMed was made on 30th December 2005 using the following terms: surfactant treatment, clinical trials and neonate, with limits of years 2000 to 2005 and age - newborn from birth to 1 month. Randomised clinical trials (RCTs) and systematic reviews of RCTs were prioritised and studies in children and animals were excluded from further analysis.
175 papers were found in this search. Only about half of these papers were directly related to some aspect of surfactant treatment and of these just over one-half were either RCTs or systematic reviews of RCTs. Of the 34 RCTs of surfactant treatment, 3 were excluded as they involved children or animals rather than neonates. Twenty-nine trials studied preterm babies with respiratory distress syndrome (RDS) and 2 were for meconium aspiration syndrome (MAS) in term infants. The median sample sizes of these studies were RDS (92, range 19-1,361) and MAS (42, range 22-61). Eighteen of the RDS trials compared two or more surfactant preparations, the most frequently studied being Curosurf and Survanta but altogether 11 different surfactants were compared. These new RCTs need to be analysed by meta-analyses in systematic reviews. Twelve systematic reviews were found and these demonstrated the superiority of prophylactic over selective use of surfactant in babies <30 weeks, natural over synthetic surfactant and the absence of an increase in long-term developmental sequelae. Surfactant for MAS may reduce the severity of respiratory illness and the need for extracorporeal membrane oxygenation. Of the non-randomised trials' novel delivery methods, failure to use evidence-based guidelines and the benefit of surfactant for babies <25 weeks were the most interesting.
Surfactant remains one of the most effective and safest interventions in neonatology. Prophylactic natural surfactant seems to be the most evidence-based treatment for babies <30 weeks. Of the newer synthetic surfactants, only Surfaxin has been compared with currently used surfactants and systematic reviews are needed to establish if it has a role in treatment of RDS. The improvement in outcome for babies <25 weeks has been due to a number of interventions: prenatal steroids, prenatal antibiotics and postnatal surfactant. Clinical trials of surfactant replacement in the neonate continue to be published with remarkable frequency.
检索近期关于新生儿表面活性剂治疗的临床试验并报告其研究结果。
近期定义为2000年至2005年间发表的文献。2005年12月30日在PubMed上进行在线检索，使用以下检索词：表面活性剂治疗、临床试验和新生儿，限定年份为2000年至2005年，年龄为出生至1个月的新生儿。优先选择随机临床试验（RCT）和RCT的系统评价，排除儿童和动物研究以作进一步分析。
本次检索共找到175篇论文。其中只有约一半的论文与表面活性剂治疗的某些方面直接相关，而这些论文中又只有略超过一半是RCT或RCT的系统评价。在34项表面活性剂治疗的RCT中，有3项因涉及儿童或动物而非新生儿而被排除。29项试验研究了早产呼吸窘迫综合征（RDS）患儿，2项针对足月儿胎粪吸入综合征（MAS）。这些研究的样本量中位数分别为RDS（92，范围19 - 1361）和MAS（42，范围22 - 61）。18项RDS试验比较了两种或更多种表面活性剂制剂，研究最频繁的是珂立苏和固尔苏，但总共比较了11种不同的表面活性剂。这些新的RCT需要在系统评价中通过荟萃分析进行分析。找到12项系统评价，这些评价表明在孕周<30周的婴儿中，预防性使用表面活性剂优于选择性使用，天然表面活性剂优于合成表面活性剂，且不会增加长期发育后遗症。用于MAS的表面活性剂可能会降低呼吸系统疾病的严重程度以及体外膜肺氧合的需求。在非随机试验的新型给药方法、未使用循证指南以及表面活性剂对孕周<25周婴儿的益处方面最受关注。
表面活性剂仍然是新生儿学中最有效和最安全的干预措施之一。预防性使用天然表面活性剂似乎是孕周<30周婴儿最具循证依据的治疗方法。在较新的合成表面活性剂中，只有珂立苏与目前使用的表面活性剂进行了比较，需要进行系统评价以确定其在RDS治疗中的作用。孕周<25周婴儿预后的改善得益于多种干预措施：产前使用类固醇、产前使用抗生素和产后使用表面活性剂。新生儿表面活性剂替代治疗的临床试验仍在以相当高的频率发表。
