Status of Propranolol for Treatment of Infantile Hemangioma and Description of a Randomized Clinical Trial

Status of Propranolol for Treatment of Infantile Hemangioma and Description of a Randomized Clinical Trial
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DOI:
10.1177/000348941112001010
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发表时间:
2011-10-01
影响因子:
1.4
通讯作者:
Bauman, Nancy M.
Bauman, Nancy M.
中科院分区:
医学3区
文献类型:
--
作者:
Menezes, Maithilee D.;McCarter, Robert;Bauman, Nancy M.

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目的:我们的主要目的是回顾普萘洛尔治疗婴儿血管瘤(IH)的现状,特别是1)开始治疗的年龄,2)开始治疗的方法,3)其他辅助治疗的使用,4)治疗的持续时间和复发率,5)不良事件,6)结果。我们的次要目标是描述一个随机,对照,单盲试验比较普萘洛尔泼尼松龙治疗IH.Methods:奥维德Medline和PubMed搜索完成的MeSH关键词“普萘洛尔”和“血管瘤。2008年6月至2010年9月期间发表了49篇英文文章,其中28篇报告了来自213名患者的数据。只有6项研究治疗了10例以上的患者,这些被选中进行详细审查(154例)。结果:治疗开始于婴儿期的患者占92.9%(平均4.5个月)。65%的患者接受2 mg/kg/天治疗,25.3%接受3 mg/kg/天治疗。在3个系列(59例患者)中,患者在治疗开始时接受过夜监测,在2个系列(62例患者)中,患者作为门诊患者接受4 - 6小时监测,在1个系列(32例患者)中,患者最初作为住院患者,但后来作为门诊患者接受监测。在约三分之二的患者(103例患者)中,普萘洛尔被用作唯一治疗。在发表时,46%的患者正在接受治疗。其余患者的平均治疗持续时间为5.1个月。平均治疗4.3个月后,21%的患者出现反弹生长。18.1%的患者发生不良事件,包括6例低血压,6例嗜睡,4例喘息,6例失眠、激越和/或噩梦,2例手凉或盗汗,3例胃食管反流,1例银屑病样皮疹。所有的作者都报告了一个有利的结果与普萘洛尔,但疗效的定义是不标准化的。结论:普萘洛尔是一个有吸引力的替代其他治疗TH。尽管这种药物明显广泛使用,但数据有限,并且缺乏针对该适应症的前瞻性研究。相对较高的不良反应发生率支持对接受该治疗的患者进行仔细监测的必要性。对不良事件的严格报告和对早期和晚期结局的客观评价对于提高我们对普萘洛尔用于该适应症的理解是必要的。
Objectives: Our primary objective was to review the current use of propranolol for treatment of infantile hemangioma (IH), specifically regarding 1) the age at initiation of therapy, 2) the method of initiation, 3) the use of other adjuvant therapy, 4) the duration of therapy and relapse rate, 5) the adverse events, and 6) the outcome. Our secondary objective was to describe a randomized, controlled, single-blinded trial comparing propranolol to prednisolone for treatment of IH.Methods: Ovid Medline and PubMed searches were completed for the MeSH keywords "propranolol" and "hemangioma." Forty-nine English-language articles were published between June 2008 and September 2010, and 28 of these reported data from a total of 213 patients. Only 6 studies treated more than 10 patients, and these were selected for review in detail (154 patients).Results: The treatment was initiated during infancy in 92.9% of patients (mean, 4.5 months). Sixty-five percent of patients were treated with 2 mg/kg per day, and 25.3% with 3 mg/kg per day. Patients were monitored overnight at initiation of treatment in 3 series (59 patients), for 4 to 6 hours as outpatients in 2 series (62 patients), and initially as inpatients but later as outpatients in 1 series (32 patients). Propranolol was used as sole therapy in about two thirds of patients (103 patients). Treatment was ongoing in 46% of patients at the time of publication. The average treatment duration in the remaining patients was 5.1 months. Rebound growth occurred in 21% of patients after a mean of 4.3 months of therapy. Adverse events occurred in 18.1% of patients and included hypotension in 6, somnolence in 6, wheezing in 4, insomnia, agitation, and/or nightmares in 6, cool hands or night sweats in 2, gastroesophageal reflux in 3, and psoriasis-like rash in 1. All authors reported a favorable outcome with propranolol, but the definition of efficacy was not standardized.Conclusions: Propranolol is an attractive alternative to other treatments for TH. Despite apparent widespread use of this medication, the data are limited, and prospective studies are lacking for this indication. The relatively high rate of adverse effects supports the need for careful monitoring of patients on this therapy. Fastidious reporting of adverse events and objective evaluation of early and late outcomes are necessary to improve our understanding of the use of propranolol for this indication.