Artificial versus natural surfactant--can we base clinical practice on a firm scientific footing?
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)
Tarnow-Mordi
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WO
Centre for Research into Human Development, University of Dundee, Ninewells Hospital and Medical School, UK.
Soll
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RF
D001688:Biological Products; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D010767:Phosphorylcholine; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy*
D001688:Biological Products; D004338:Drug Combinations; D005233:Fatty Alcohols; D011663:Pulmonary Surfactants; D010767:Phosphorylcholine; D011092:Polyethylene Glycols; C047049:dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination; C072197:beractant