- 作者：Luca Filippi ; Giacomo Cavallaro ; Paola Bagnoli ; Massimo Dal Monte ; Patrizio Fiorini ; Gianpaolo Donzelli ; Francesca Tinelli ; Gabriella Araimo ; Gloria Cristofori ; Giancarlo la Marca ; Maria Luisa Della Bona ; Agostino La Torre ; Pina Fortunato ; S ; ra Furlanetto ; Silvia Osnaghi ; Fabio Mosca
- 关键词：尾-AR ; 尾-adrenoreceptor ; GA ; Gestational age ; OIR ; Oxygen-induced retinopathy ; ROP ; Retinopathy of prematurity ; VEGF ; Vascular endothelial growth factor
- 刊名：The Journal of Pediatrics
- 出版年：December, 2013
- 年：2013
- 卷：163
- 期：6
- 页码：1570-1577.e6
- 全文大小：1902 K
lass="h4">Objective
To evaluate safety and efficacy of oral propranolol administration in preterm newborns affected by an early phase of retinopathy of prematurity (ROP).lass="h4">Study design
Fifty-two preterm newborns with Stage 2 ROP were randomized to receive oral propranolol (0.25 or 0.5 mg/kg/6 hours) added to standard treatment or standard treatment alone. To evaluate safety of the treatment, hemodynamic and respiratory variables were continuously monitored, and blood samples were collected weekly to check for renal, liver, and metabolic balance. To evaluate efficacy of the treatment, the progression of the disease (number of laser treatments, number of bevacizumab treatments, and incidence of retinal detachment) was evaluated by serial ophthalmologic examinations, and plasma soluble E-selectin levels were measured weekly.
lass="h4">Results
Newborns treated with propranolol showed less progression to Stage 3 (risk ratio 0.52; 95% CI 0.47-0.58, relative reduction of risk 48%) or Stage 3 plus (relative risk 0.42 95% CI 0.31-0.58, relative reduction of risk 58%). The infants required fewer laser treatments and less need for rescue treatment with intravitreal bevacizumab (relative risk 0.48; 95% CI 0.29-0.79, relative reduction of risk 52 %), a 100% relative reduction of risk for progression to Stage 4. They also had significantly lower plasma soluble E-selectin levels. However, 5 of the 26 newborns treated with propranolol had serious adverse effects (hypotension, bradycardia), in conjunction with episodes of sepsis, anesthesia induction, or tracheal stimulation.
lass="h4">Conclusion
This pilot study suggests that the administration of oral propranolol is effective in counteracting the progression of ROP but that safety is a concern.