普萘洛尔治疗婴儿血管瘤(IH)已被证明是有效和相对安全的。然而，其他亲脂性较低的β-受体阻滞剂，如纳多洛尔，可能更适用于普萘洛尔无反应或出现不良事件的患者。目的:探讨口服纳多洛尔与口服普萘洛尔治疗婴幼儿IH的非劣效性和安全性。

这项双盲非劣效性前瞻性研究的非劣效性差幅为10%,比较普萘洛尔和纳多洛尔对1至6个月的IH问题婴儿的疗效。该研究于2016年至2020年间在加拿大的2个学术儿科皮肤病中心进行。1至6个月大的婴儿，面部血管瘤大于1.5厘米，或身体其他部位血管瘤大于3厘米，导致或可能导致功能障碍或美容缺陷。

这项研究包括71名患者。其中36人接受了普萘洛尔治疗。该组的平均(SD)年龄为3.1 (1.4)个月，31名个体(86%)为女性。35名婴儿接受了纳多洛尔治疗。该组的平均(SD)年龄为3.2 (1.6)个月，26名个体(74%)为女性。通过t检验，各组之间的IH差异在大小方面为8.8 (95% CI，2.7-14.9)，在颜色方面为17.1 (95% CI，7.2-30.0)，有利于纳多洛尔组，表明纳多洛尔不劣于普萘洛尔。在第52周时发现了类似的差异:大小和颜色的改善分别为6.0 (95% CI，1.9-10.1)和10.1 (95% CI，2.9-17.4)。对于每增加一倍的时间单位(周),与普萘洛尔相比，纳多洛尔的消退系数高2.4 (95% CI，0.5-4.4)。2次干预的安全性数据相似。口服纳多洛尔并不劣于口服普萘洛尔，这表明在普萘洛尔无反应或不良事件的情况下，或当需要更快消退时，它可能是一种有效和安全的替代方法。

Abstract

Importance: Propranolol for infantile hemangiomas (IH) has been shown to be effective and relatively safe. However, other less lipophilic β-blockers, such as nadolol, may be preferable in individuals who experience propranolol unresponsiveness or adverse events.

Objective: To document the noninferiority and safety of oral nadolol compared with oral propranolol in infants with IH.

Design, setting, and participants: This double-blind noninferiority prospective study with a noninferiority margin of 10% compared propranolol with nadolol in infants aged 1 to 6 months with problematic IH. The study was conducted in 2 academic pediatric dermatology centers in Canada between 2016 and 2020. Infants aged 1 to 6 months with a hemangioma greater than 1.5 cm on the face or 3 cm or greater on another body part causing or with potential to cause functional impairment or cosmetic disfigurement.

Interventions: Oral propranolol and nadolol in escalating doses up to 2 mg/kg/d.

Main outcomes and measure: Between-group differences comparing changes in the bulk (size and extent) and color of the IH at week 24 with baseline using a 100-mm visual analog scale.

Results: The study included 71 patients. Of these, 36 were treated with propranolol. The mean (SD) age in this group was 3.1 (1.4) months, and 31 individuals (86%) were female. Thirty-five infants were treated with nadolol. The mean (SD) age in this group was 3.2 (1.6) months, and 26 individuals (74%) were female. The difference in IH between groups by t test was 8.8 (95% CI, 2.7-14.9) for size and 17.1 (95% CI, 7.2-30.0) for color in favor of the nadolol group, demonstrating that nadolol was noninferior to propranolol. Similar differences were noted at 52 weeks: 6.0 (95% CI, 1.9-10.1) and 10.1 (95% CI, 2.9-17.4) for size and color improvement, respectively. For each doubling of time unit (week), the coefficient of involution was 2.4 (95% CI, 0.5-4.4) higher with nadolol compared with propranolol. Safety data were similar between the 2 interventions.

Conclusions and relevance: Oral nadolol was noninferior to oral propranolol, indicating it may be an efficacious and safe alternative in cases of propranolol unresponsiveness or adverse events, or when faster involution is required.

原文链接

pubmed.ncbi.nlm.nih.gov/34747977/

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