pulmicort and hydrocortisone-hemisuccinate

In 1999, 80% of French neonatal centers used corticosteroids, mainly betamethasone (BMT), to prevent or treat bronchopulmonary dysplasia (BPD) [Lee SK, McMillan DD, Ohlson A, et al. Variations in practice and outcomes in the canadian NICU Network 1996-1997. Pediatrics 2000;106:1070-9]. As many data suggested a low risk-benefit ratio, an updated assessment of this use was necessary [Desnoulez L, Empana J, Anceschi M, et al. Prise en charge de l'immaturité pulmonaire en néonatologie : enquête sur les pratiques européennes. Arch Pediatr 2005;12:4-9; Halliday HL, Ehrenkranz RA, Doyle LW. Early postnatal (less than 96h) corticosteroids for preventing chronic lung disease in preterm infants. Cochrane Database Syst Rev 2003:CD001146; Yeh TF, Lin YJ, Lin HC, et al. Outcomes at school age after postnatal dexamethasone therapy for lung disease of prematurity. N Engl J Med 2004;350:1304-13; Lin YJ, LKin CH, Wu JM, et al. The effects of early postnatal dexamethasone therapy on pulmonary outcome in premature infants with respiratory distress syndrome: a 2-year follow-up study. Acta Paediatr 2005;94:310-16].. Questionnaires addressing the use of and indications for corticosteroids were sent to all French neonatal centers.. The study was conducted over 5 months (July to November 2006). Of 202 questionnaires sent out, 186 (92%) were completed. Of these 186 centers, 147 (79%) had a standard protocol for corticosteroid use, covering systemic and inhaled steroids (76 units), only systemic steroid therapy (30 units) and only inhaled steroids (41 units). Systemic corticosteroids were used in 106 centers for hemodynamic purposes in 42 cases (40%), prevention of BPD in 1 case (1%), early treatment of BPD (day 4 to day 21) in 23 cases (22%) and late treatment of BPD (after day 21) in 74 cases (70%). Hemisuccinate hydrocortisone (HSHC) was the only corticoid used for hemodynamic failure. The steroid used for early treatment of BPD was BMT (21 out of 23). The duration of treatment was less than 4 days in 10 centers (43%). The steroid most often used for late treatment was BMT (67 out of 74). The duration of treatment was less than 4 days in 29 centers, between 4 and 8 days in 22 centers, and longer than 8 days in 26 centers. Among 117 centers administering corticosteroids by inhalation, 74% used budesonide. Use of corticosteroids was higher in teaching hospitals (86%) than in others (49%), likely due to the immaturity of the neonates hospitalized in these centers.. We showed a still frequent use of corticosteroids in preterm infants in France but only after the fourth day of life to treat BPD and not as a prevention therapy. We also found a marginal use of DXM in accordance with both short-term and long-term adverse side effects, suggesting an unbalanced risk-benefit ratio even though it has a beneficial effect on respiratory status. Our findings indicate the need for national recommendations and trials to assess oral BMT treatment in premature neonates with BPD.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Betamethasone; Bronchopulmonary Dysplasia; Budesonide; Dexamethasone; Drug Administration Schedule; Drug Utilization; Female; Follow-Up Studies; France; Gestational Age; Glucocorticoids; Hemodynamics; Humans; Hydrocortisone; Infant, Low Birth Weight; Infant, Newborn; Infusions, Intravenous; Male; Prednisolone; Respiratory Distress Syndrome, Newborn; Risk Assessment; Surveys and Questionnaires

In inhalation therapy preservation of the stability of an aerosolized drug molecule while nebulisation is an important factor determining its clinical efficacy and safety. The influence of nebulisation with employment of ultrasonic and jet methods using compressed air and oxygen as aerosol carriers on the stability of inhaled hydrocortisone hemisuccinate, budesonide and flunisolide was investigated. Collected aerosol samples were analyzed using thin layer chromatography and compared with standard solution samples in UV-wavelength chi = 254 nm. The appearance of additional fluorescence exctinction points by ultrasonic and air jet methods produced hydrocortisone hemisuccinate aerosol samples and by an ultrasonic method produced budesonide aerosol sample were observed. This could provide evidence for affecting stability and appearance of desintegration products of hydrocortisone hemisuccinate and budesonide while nebulisation using aforementioned methods. In the context of the obtained results the stability of a flunisolide molecule remains unaffected. Furthermore, the process of steroids solution condensation on the membrane of the nebuliser and in inhalation vessel were seen. The phenomena of molecule desintegration and solution condensation as well stated while nebulisation lead to reduction of the inhaled steroid dose accessible for a patient.

Topics: Administration, Inhalation; Aerosols; Air; Anti-Inflammatory Agents; Budesonide; Chemistry, Pharmaceutical; Chromatography, Thin Layer; Drug Stability; Fluocinolone Acetonide; Glucocorticoids; Hydrocortisone; Nebulizers and Vaporizers; Oxygen