Evaluation of the Efficacy and Safety of Low-Dose Propranolol Combined With Intralesional Bleomycin for Infantile Hemangioma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Clinical Therapeutic Effect
研究概览
简要总结
This is a prospective, randomized controlled trial designed to evaluate the efficacy and safety of low-dose oral propranolol (1 mg/kg/day) combined with monthly intralesional bleomycin injections versus low-dose propranolol monotherapy for the treatment of infantile hemangioma (IH). A total of 260 infants were randomized to either the combination group or the control group. The study aims to determine if the combination therapy offers superior clinical outcomes, including faster regression, better color resolution, and reduced scarring over a 6-month treatment period.
详细描述
Infantile hemangioma (IH) is the most common benign vascular tumor in infancy. While oral propranolol is the first-line systemic therapy, its efficacy can be limited or slow for certain IHs. Intralesional bleomycin offers a targeted local therapy. This study investigates whether combining low-dose propranolol with local bleomycin injections can enhance therapeutic effects while maintaining a good safety profile. This prospective, randomized, controlled, open-label trial with blinded outcome assessment enrolled 260 infants with IH. Participants were randomly assigned to receive either oral propranolol (1 mg/kg/day) plus monthly intralesional bleomycin (Combination Group) or oral propranolol (1 mg/kg/day) alone (Control Group) for 6 months. The primary objective is to compare the clinical therapeutic effect between the two groups at 6 months. Secondary objectives include evaluating early tumor response, changes in tumor volume and color, long-term scar formation, and the incidence of adverse events. The findings aim to provide robust evidence for a potentially more effective combination treatment strategy for IH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤12 months.
- •Clinically and/or imaging-diagnosed infantile hemangioma requiring treatment.
- •No prior treatment for IH.
- •Guardians willing to comply with the study protocol and provide informed consent.
排除标准
- •Known hypersensitivity to propranolol or bleomycin.
- •Congenital or mixed hemangiomas distinct from IH.
- •Significant cardiopulmonary, hepatic, or renal dysfunction.
- •Presence of other severe systemic diseases.
- •PHACE syndrome or major congenital anomalies that could interfere with treatment or assessment.
研究组 & 干预措施
Experimental: Combination Therapy Group
Participants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses) for 6 months, combined with intralesional injections of bleomycin. Bleomycin injections were administered once a month for up to 6 months.
干预措施: Propranolol + Bleomycin (Drug)
Active Comparator: Propranolol Monotherapy Group
Participants received oral propranolol hydrochloride solution at a dose of 1 mg/kg/day (in two divided doses). The total treatment duration was 6 months.
干预措施: Propranolol (Drug)
结局指标
主要结局
Clinical Therapeutic Effect
时间窗: 6 Months
Categorized as Complete Regression (\>95% volume reduction), Marked Effectiveness (≥75% to 95% volume reduction), Effective (30% to \<75% reduction), or Ineffective (\<30% reduction). The primary measure is the rate of participants achieving Complete Regression or Marked Effectiveness.
次要结局
- Early Tumor Surface Atrophy(24 hours after the first treatment)
- Change in Hemangioma Color Score(Baseline, 6 Months)
- Change in Tumor Volume(Baseline, 6 Months)
- Vancouver Scar Scale (VSS) Score(6 Months)
- Incidence of Adverse Events(Through study completion (6 months))
研究者
Bin Zhou
Principal investigator
Wuhan Integrated Traditional Chinese and Western Medicine Hospital