Efficacy and safety of propranolol tablets vs. oral solution in neonates with severe infantile hemangiomas: a retrospective study in China.
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The objective of this study was to evaluate the efficacy and safety of propranolol hydrochloride tablets and oral solution in neonates with severe IHs. A retrospective cohort study included 184 consecutive neonates diagnosed with severe IHs and treated with propranolol from January 2016 to June 2023. Of these, 126 patients received propranolol tablets, and 58 received propranolol oral solution. The primary outcome assessed the treatment response post-discontinuation of propranolol, while the key secondary outcome measured changes in the hemangioma activity score (HAS). Out of 184 participants, 138 (75.5%) were female. The mean age at treatment initiation was 16 days (range: 10-22) for the tablet group and 14 days (range: 8-24) for the oral solution group. Following treatment, effective response rates were 74.6% in the tablet group and 87.9% in the oral solution group (P = 0.04). Improvement in the HAS was 63.95% for the tablet group and 65.57% for the oral solution group (P = 0.35). Adverse reactions included diarrhea in 29.0% of tablet group and 12.9% of oral solution group (P = 0.01), and sleep disturbances in 20.6% of tablet group and 8.6% of oral solution group (P = 0.04). In terms of sequelae, telangiectasia occurred in 34.9% of tablet group and 17.2% of oral solution group (P = 0.01). Propranolol oral solution showed superior efficacy and safety compared to tablets in treating neonates with severe IHs, suggesting it should be prioritized as the preferred treatment option for this vulnerable population.