專題討論2:早產預防、處理、及早產兒照顧之新進展

程 序 表

S2-5
Prevention of Bronchopulmonary Dysplasia (BPD)---A New Therapeutic Regimen
葉純甫
台北醫學大學附設醫院婦幼研究中心

  BPD is continuously the most important complication in preterm infants following mechanical ventilation. There has been no definite therapy that can eliminate this complication. The pathogenesis is not completely clear but lung inflammation may play a central role in the development of BPD.      Systemic glucocorticoid, in particular, dexamethasone, is by far, the most effective therapy to minimize or prevent BPD. However, because of the long-term adverse effects, systemic glucocorticoid therapy is not generally recommended. Inhaled glucocorticoid is technically difficult and less effective and in fact may be associated with a higher mortality. It is there for important to find a therapeutic method that can reduce the systemic side of glucocorticoids while at the same time maintaining its local anti-inflammatory effects on the lung. Our previous studies in neonate and those studies in animal by others indicated that surfactant can be used as a vehicle to deliver a topical glucocorticoid, such as budesonide, to the lung periphery and effectively suppress lung injury and lung inflammation. To use surfactant as vehicle is based on a physical phenomenon “Maragonic effect”.  Surfactant can be used as an effective vehicle to facilitate the migration of a topical steroid, such as budesonide, to the peripheral lung.  Our previous studies indicated that intra-tracheal instillation of surfactant/budesonide significantly lower incidence the incidence of BPD or death than instillation of surfactant alone. [55/131 (42 %) vs 89/134 (66%) ; risk ratio 0.58, 95% CI: 0.44 to 0.77, P < 0.001; number of infant needed to treat for decreasing one BPD or death was 4.1 (95% CI: 2.8 to 7.8). Intervention group required significantly fewer doses of surfactant than control group.
  Curosurf, another natural surfactant derived from pig lungs has a higher concentration of phospholipid than survanta.  Clinical experience suggested that it has a faster effect and may need less dosage than survanta and therefore may be more cost and benefit.  Our in-vitro study indicated that curosurf has a higher Marangoni effect and migrate faster, about 4x than that of survanta, and theoretically may be more effective as a vehicle. We therefore initiate a study using curosurf as vehicle to deliver budesonide in infants who requires surfactant base on the current surfactant therapy modality.  A multi-centers double blind study was therefore conducted in Taiwan using Curosurf as vehicle.  We intend to include 320 infants <1500 gram who requires intra-tracheal surfactant therapy, this is based on a 33% improvement in incidence of BPD or death with a power of 90%.  A Data Safety Monitor Board has evaluated the first 30 infants and indicated that no apparently significant adverse effect was noted and the study can be continued.