Oral versus high-dose pulse corticosteroids for problematic infantile hemangiomas: a randomized, controlled trial

Pediatrics. 2007 Jun;119(6):e1239-47. doi: 10.1542/peds.2006-2962. Epub 2007 May 7.

Abstract

Objectives: Oral systemic corticosteroids are the mainstay of treatment for problematic hemangiomas; however, current information is based on anecdotal experience and retrospective studies. We aimed to determine whether systemic steroids are efficacious in proliferating hemangioma and to compare the efficacy and safety of 2 corticosteroid treatment modalities.

Patients and methods: Twenty patients with problematic hemangiomas of infancy were randomly assigned to either daily oral prednisolone or monthly intravenous pulses of methylprednisolone. Their clinical outcomes (improvement using a visual analog score) and adverse events were compared at 3 months from baseline and 1 year of age. Data on possible surrogate markers of angiogenesis were available for the first 3 months.

Results: At 3 months, orally treated patients had a median visual analog score of 70 compared with 12 in the intravenous group. This response pattern was similar at the patients' first birthday: 50.0 vs -1.5. Additional treatment beyond 3 months was needed for 65% of the patients (7 in the intravenous and 6 in the oral group). Six of 8 patients with impaired vision at enrollment had an improved function at 1 year (4 patients in the intravenous group and 3 patients in the oral group). Of the 4 surrogate markers of angiogenesis measured (plasma basic fibroblast growth factor, vascular endothelial growth factor, vascular cellular adhesion molecule 1, endoglin, and urine basic fibroblast growth factor), the only 2 that decreased over time were vascular cellular adhesion molecule 1 and endoglin. Patients in the oral group had a higher rate of adverse effects, such as hypertension (18.6% vs 13.1%), abnormal cortisol (78% vs 60%), and growth retardation.

Conclusions: Systemic corticosteroids are efficacious in stopping the proliferation of hemangiomas. The oral corticosteroids offered more clinical and biological benefit than the pulse steroids with higher risk of adverse effects.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects
  • Biomarkers / blood
  • Female
  • Hemangioma / blood
  • Hemangioma / drug therapy*
  • Hemangioma / pathology
  • Humans
  • Hypertension / chemically induced
  • Infant
  • Injections, Intravenous
  • Male
  • Pain Measurement / drug effects
  • Respiratory Distress Syndrome / chemically induced
  • Vascular Cell Adhesion Molecule-1 / blood

Substances

  • Adrenal Cortex Hormones
  • Biomarkers
  • Vascular Cell Adhesion Molecule-1