Propranolol (1 mg/kg/day) with intralesional bleomycin versus propranolol monotherapy for infantile hemangioma: a randomized controlled trial
Bibliographic record
Abstract
Objective To evaluate the efficacy and safety of oral propranolol (1 mg/kg/day) combined with intralesional bleomycin injections versus propranolol monotherapy at the same dosage for infantile hemangioma (IH). This study investigates if a low-dose propranolol regimen can be enhanced with local therapy to improve outcomes while maintaining a favorable safety profile. Methods This single-center, prospective, randomized controlled trial enrolled 260 infants (aged 3–11 months, mean age 5.34 ± 2.57 months) with IH requiring systemic therapy. Participants were randomly assigned (1:1) to either the combination group (propranolol plus monthly intralesional bleomycin, n = 130) or the monotherapy group (propranolol alone, n = 130). The primary efficacy endpoint was the proportion of patients achieving an excellent therapeutic response (complete regression or marked effectiveness) at 6 months. Secondary outcomes included early therapeutic response, changes in hemangioma color score, tumor volume reduction, Vancouver Scar Scale (VSS) scores, and incidence of adverse events. Results Baseline characteristics were comparable. After 6 months, a significantly higher proportion of patients in the combination group achieved the primary endpoint (77.69% vs. 50.00%; P < 0.001). The combination group had higher rates of complete regression (33.07% vs. 15.38%, P = 0.001) and marked effectiveness (44.61% vs. 34.61%, P = 0.083). A superior early response was noted in the combination group, with a more pronounced degree of tumor atrophy within 24 h (P < 0.001). Post-treatment color scores (change from baseline, P < 0.001) and tumor volume (1.63 ± 0.70 cm 3 vs. 3.27 ± 1.06 cm 3 , P < 0.001) were significantly better in the combination group. VSS scores were significantly lower in the combination group (3.68 ± 0.37 vs. 5.75 ± 0.64; P < 0.001), indicating less scarring. Safety profiles were comparable. Conclusion In infants with IH, augmenting a low-dose oral propranolol regimen (1 mg/kg/day) with monthly intralesional bleomycin is significantly more effective than low-dose propranolol monotherapy. This combination strategy accelerates tumor regression and yields superior cosmetic outcomes, all while maintaining a comparable safety profile.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".