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DOI: 10.1055/s-2004-44899
© Georg Thieme Verlag Stuttgart · New York
A Comparison of Efficacy Between Two Natural Exogenous Surfactant Preparations in Premature Infants with Respiratory Distress Syndrome
Vergleich der Wirkung zweier natürlicher Surfactantpräparate in der Therapie des Atemnotsyndroms FrühgeborenerPublikationsverlauf
Publikationsdatum:
29. Juli 2004 (online)

Abstract
The mortality and various morbidity rates have been substantially reduced by means
of exogenous surfactant replacement, the cornerstone in the treatment of respiratory
distress syndrome (RDS) in premature infants.
The objective of this study is to compare two natural surfactant preparations (Alveofact®,
Survanta®) in terms of effectiveness and side-effects.
A total of 50 infants with RDS were given surfactant due to RDS were taken into the
scope of this study. Survanta® and Alveofact® were administered to randomized infants
with RDS and the results obtained during clinical observations were compared.
Second hour mean FiO2, MAP and a/APO2 values showed changes in favour of Alveofact® (n = 25) group compared to the Survanta®
(n = 25) group (p < 0.05 for each parameter). However, this difference disappeared
in the 6th hour. No statistical difference was established between the two groups with regard
to sideeffects (pneumothorax, sepsis, intraventricular hemorrhage, bronchopulmonary
dysplasia), duration of mechanical ventilation in survivors, duration of hospitalization
in survivors and mortality before the 28th day.
It was concluded that results obtained with different surfactant preparations having
dissimilar compositions were not different in terms of final impacts and side-effects.
Zusammenfassung
Die Mortalität und Morbidität Frühgeborener konnte durch den Einsatz von exogenem
Surfactant in der Therapie des Atemnotsyndroms Frühgeborener (RDS) bedeutsam gesenkt
werden.
Das Ziel der vorliegenden Studie war es, zwei natürliche Surfactantpräparationen (Alveofact®
und Survanta®) hinsichtlich der Wirkung und möglicher Nebenwirkungen zu vergleichen.
Insgesamt 50 Frühgeborene mit RDS wurden mit Surfactant behandelt. Alveofact® oder
Survanta® wurden nach Randomisierung Frühgeborenen mit RDS intratracheal gegeben und
die klinischen Behandlungsresultate verglichen.
Die 2-Stunden-Werte nach Applikation für FiO2, mittleren Atemwegsdruck (MAP) und die alveoloarterielle Ratio des Sauerstoffpartialdrucks
zeigten einen verbesserten Effekt von Alveofact® (n = 25) im Vergleich zur Survanta®-behandelten
Gruppe (n = 25) an (p < 0,05 für jede Variable).
Dieser Unterschied war jedoch jenseits der 6. Stunde nicht mehr nachweisbar.
Keine statistische signifikanten Unterschiede wurden zwischen beiden Gruppen hinsichtlich
der Nebenwirkungen bzw. begleitender Morbidität gefunden (Pneumothorax, Sepsis, intraventrikulärer
Hämorrhagie, bronchopulmonale Dysplasie), Zeitdauer der mechanischen Beatmung, Zeitdauer
des Hospitalisierung und Mortalität bis zum 28. Lebenstag.
Es wird geschlussfolgert, dass die Behandlungsresultate mit verschiedenen natürlichen
Surfactantpräparationen hinsichtlich der mittelfristigen Zielvariablen sowie der Nebenwirkungen
nicht different waren.
Key words
Alveofact® - natural surfactant - premature - respiratory distress syndrome - Survanta®
Schlüsselwörter
Alveofact® - Natural surfactanten - Frühgeborenen - Atemnotsyndrom - Survanta®
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MD Nilgun Kultursay
Ege University Medical School
Department of Pediatrics
Bornova
35100 Izmir
Turkey
Telefon: +90/2 32/3 42-69 90
Fax: +90/2 32/3 42-69 90
eMail: nkultur@med.ege.edu.tr