Propranolol (1 mg/kg/day) with intralesional bleomycin versus propranolol monotherapy for infantile hemangioma: a randomized controlled trial.

Summary

In 260 infants with infantile hemangioma, adding monthly intralesional bleomycin to low-dose propranolol significantly increased the 6-month excellent response rate versus propranolol alone and doubled complete regression rates. Early atrophy within 24 hours and improvements in color and volume were greater with combination therapy, with a comparable safety profile.

Key Findings

• Excellent therapeutic response at 6 months: 77.69% (combination) vs 50.00% (monotherapy); P < 0.001
• Complete regression: 33.07% vs 15.38%; P = 0.001
• Greater early response with more pronounced tumor atrophy within 24 hours; P < 0.001
• Significant improvements in color scores and tumor volume reduction from baseline (P < 0.001)
• Comparable safety profile between groups in this trial

Clinical Implications

For infants requiring systemic therapy for IH, consider adding intralesional bleomycin to low-dose propranolol to enhance early and overall responses and optimize cosmetic outcomes, with appropriate monitoring.

Limitations

• Single-center study limits generalizability
• Blinding and allocation concealment are not detailed; short (6-month) primary follow-up

Future Directions

Multicenter, blinded RCTs with standard-dose comparators and longer follow-up should assess durability, relapse, optimal dosing intervals, and safety, including VSS and functional outcomes.