Impact of propranolol formulation on treatment response and adverse events in infantile hemangioma: A single-center retrospective cohort study

Infantile hemangiomas (IHs) are the most common benign vascular tumors in infancy, often leading to functional impairment, or cosmetic sequelae. While propranolol hydrochloride is the established first-line therapy, formulation differences may influence dosing precision, safety, and therapeutic response. This study aimed to compare the clinical efficacy and safety of oral solution and tablet formulations in infants diagnosed with IH. This single-center retrospective cohort study reviewed medical records of 120 infants (aged 0-12 months) treated with propranolol at Xuzhou Children's Hospital between September 2023 and December 2024. Patients were categorized into an oral solution group (n = 60) and a tablet group (n = 60). Lesion volume was calculated using the ellipsoid formula at baseline and follow-up intervals of 1 week, 1 month, 2 months, and 3 months. Primary outcomes included improvement rate and efficacy grading; secondary outcomes assessed adverse events and subgroup responses. P < .05 was considered statistically significant. Baseline characteristics were comparable between groups (P > .05). While both formulations resulted in progressive reductions in lesion volume, the oral solution group demonstrated greater improvement at all follow-up points. At 3 months, the improvement rate, presented as mean ± standard deviation, was 85.37% ± 10.78 in the oral group vs 69.50% ± 9.78 in the tablet group (median difference: 13.24%; 95% CI: 11.81-15.47%; P < .001). A higher proportion of excellent responses was observed in the oral group (66% vs 40%, percentage difference: 26.7%; 95% CI: 9.5-43.9%; P = .021). No significant differences were found in adverse events (P = .349). Subgroup analyses revealed that lesion subtype and anatomical location did not significantly influence treatment response (P > .05). Both propranolol formulations were effective and well-tolerated. The oral solution demonstrated a greater clinical improvement with a comparable safety profile. Further prospective multicenter studies are warranted to confirm these findings.