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临床试验/NCT02342275
NCT02342275已完成3 期

Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma

West China Hospital1 个研究点 分布在 1 个国家目标入组 377 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
377
试验地点
1
主要终点
The Primary Outcome Measure Was Any Response at 6 Months

研究概览

简要总结

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

详细描述

Currently, propranolol is the preferred treatment for problematic proliferating infantile hemangiomas (IHs). Although propranolol is clearly efficacious, rare side effects, such as hypoglycemia, may be life-threatening. The possibility of propranolol resistance and treatment failure is also important, and highlights the need for employing more established techniques in certain cases.

Nonselective β-adrenergic antagonists, such as propranolol and timolol, are competitive antagonists of catecholamines at the β1- and β2-adrenergic receptors (β-ARs). β2-AR blockade may result in hypoglycemia as a result of decreased glycogenolysis, gluconeogenesis, and lipolysis. Moreover, bronchial hyperreactivity is a direct effect of nonselective β-blockers, resulting in bronchospasms due to pulmonic β2-AR blockade. A solution to minimize many of the side effects of nonselective β-blocker therapy may be the use of more selective β1-blockers such as metoprolol or atenolol, which, at low dosages, have little β2 activity. Unfortunately, there is a paucity of clinical data comparing the efficacy of selective and non-selective β-blocker. Furthermore, because of the broad heterogeneity of IH (e.g., proliferating versus involuting), confounding with other pharmacologic exposures (e.g., corticosteroids), associated complications (e.g., ulceration) and comorbid medical anomalies (e.g., PHACE) that can influence efficiency after IH treatment, observational studies are unable to definitively establish the clinical utility of β-blockers in IH. Thus, questions regarding the efficacy of the subtypes of β-blockers must be answered in randomized controlled trials, which may provide the only way to overcome the selection and ascertainment bias.

The purpose of this study is to compare the efficacy of orally administered propranolol versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 24 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Patients younger than 24 weeks.
  • Presenting a hemangioma with the following characteristics:
  • Subcutaneous and/or cutaneous
  • Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.
  • Consent of both parents (or the person having parental authority in families)

排除标准

  • Infant presenting contraindications for the administration of propranolol or atenolol.
  • Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only other treatments.
  • Patients with an inability to participate or to follow the study treatment and assessment plan.

研究组 & 干预措施

Propranolol

Active Comparator

Propranolol

干预措施: Propranolol (Drug)

Atenolol

Active Comparator

Atenolol

干预措施: Atenolol (Drug)

结局指标

主要结局

The Primary Outcome Measure Was Any Response at 6 Months

时间窗: 6 month

Changes in IH size and color were classified as a complete response, nearly complete response, partial response or no response. The primary outcome measure was any response at 6 months in the intention-to-treat population of all patients who underwent randomization. The any response included compete, nearly complete and partial responses. A complete response was defined as no redundant tissue or telangiectasia was identified. A nearly complete response was defined as a minimal degree of telangiectasis, erythema and skin thickening. A partial response was defined as a size reduction or change in color that did not meet the nearly complete resolution criteria.

次要结局

  • Number of Participants With Complete/Nearly Complete Response (96 Week)(96 week)
  • Complete Ulceration Healing Time(from the first dosage of propranolol or atenolol until complete healing ofthe hemangioma ulceration.)
  • Hemangioma Activity Score (HAS)(Baseline and at 1, 4, 12, and 24 weeks)
  • Successful Initial Response(1 week after treatment)
  • Rebound Rate(between weeks 24 and 96)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi Ji

Doctor

West China Hospital

研究点 (1)

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