Tarnow-Mordi W O, Soll R F
Centre for Research into Human Development, University of Dundee, Ninewells Hospital and Medical School, UK.
Eur J Pediatr. 1994;153(9 Suppl 2):S17-21. doi: 10.1007/BF02179668.
Now that surfactant is in widespread use, clinical trials are beginning to address the critical question of whether the choice of surfactant really matters in terms of major morbidity and mortality. The trials reported so far focus on the effects of artificial and natural surfactant on acute gas exchange and duration of oxygen or ventilation therapy. Although the number of infants recruited to comparative trials of different surfactants is increasing, we are still a long way from being able reliably to answer the question 'Which type of surfactant should we use and under what circumstances?' In understanding the uncertainty in this field it is pertinent to consider the interrelationships between three levels of research for any new therapy in clinical science. At the first level animal studies or case reports suggest potential clinical benefits. At the second, more focused physiological studies and trials address questions of mechanism. At the third, definitive randomised trials compare major adverse clinical outcomes in human patients. Only studies conducted at this third level can finally establish clinical practice on a firm scientific footing. In this review, a preliminary meta-analysis of 801 patients recruited in three trials of artificial (Exosurf) versus natural (Survanta) surfactant shows no clear advantage for either surfactant but does not rule out moderate differences in major adverse outcomes. To establish reliably whether such differences exist will require large multicentre clinical trials.(ABSTRACT TRUNCATED AT 250 WORDS)
既然表面活性剂已得到广泛应用,临床试验开始着手解决一个关键问题,即就主要发病率和死亡率而言,表面活性剂的选择是否真的重要。迄今为止报道的试验聚焦于人工合成表面活性剂和天然表面活性剂对急性气体交换以及氧气或通气治疗时长的影响。尽管参与不同表面活性剂对比试验的婴儿数量在增加,但我们距离能够可靠地回答“我们应该使用哪种类型的表面活性剂以及在何种情况下使用?”这个问题仍有很长的路要走。在理解该领域的不确定性时,考虑临床科学中任何新疗法的三个研究层面之间的相互关系是恰当的。在第一个层面,动物研究或病例报告表明可能存在临床益处。在第二个层面,更具针对性的生理学研究和试验解决机制问题。在第三个层面,确定性随机试验比较人类患者的主要不良临床结局。只有在这第三个层面开展的研究才能最终在坚实的科学基础上确立临床实践。在本综述中,对三项人工合成表面活性剂(Exosurf)与天然表面活性剂(Survanta)试验中招募的801例患者进行的初步荟萃分析显示,两种表面活性剂均无明显优势,但也不排除主要不良结局存在适度差异。要可靠地确定此类差异是否存在,将需要大型多中心临床试验。(摘要截选至250词)