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与至少接受口服普萘洛尔治疗 6 个月的儿童婴儿血管瘤早期复发相关的因素:2014-2021 年法国西部 DataHub 的病例对照研究。

Factors associated with early relapse of infantile haemangioma in children treated for at least six months with oral propranolol: A case-control study using the 2014-2021 French Ouest DataHub.

机构信息

Department of Dermatology, CHU Rennes, 35000 Rennes, France.

University of Tours, INSERM 1246-SPHERE, Department of Dermatology, Tours University Hospital, F-37000 Tours, France; Dermatology Department and Reference Centre for Rare Diseases and Vascular Malformations (MAGEC), Tours University Hospital, 37000 Tours, France.

出版信息

Ann Dermatol Venereol. 2023 Sep;150(3):189-194. doi: 10.1016/j.annder.2023.03.007. Epub 2023 May 22.

DOI:10.1016/j.annder.2023.03.007
PMID:37225615
Abstract

BACKGROUND

The factors associated with early relapse of infantile haemangioma (IH) after a first course of treatment with oral propranolol for at least six months (initiated after the marketing authorization had been granted) have not previously been investigated.

OBJECTIVES

To identify factors associated with the risk of early relapse in children with IH treated with oral propranolol according to the current prescribing guidelines.

METHODS

We performed a multicentre, retrospective, case-control study, using the Ouest Data Hub database. All children treated for at least 6 months with oral propranolol for IH between 31 June 2014 and 31 December 2021, and with a follow-up visit at least three months after treatment discontinuation were included. A case was defined as relapse of IH within three months of treatment discontinuation; each case was matched for age at treatment initiation and for centre, with four (relapse-free) controls. The association between relapse and treatment or IH characteristics was expressed as an odds ratio (OR) from univariate and multivariate conditional logistic regressions.

RESULTS

A total of 225 children were included. Of these, 36 (16%) relapsed early. In a multivariate analysis, a deep IH component was a risk factor for early relapse [OR = 8.93; 95%CI: 1.0-78.9, p = 0.05]. A propranolol dosage level of less than 3 mg/kg/day protected against early relapse [OR = 0.11; 95%CI: 0.02-0.7, p = 0.02]. Tapering before propranolol discontinuation was not associated with a lower risk of early relapse.

CONCLUSION

The risk factors for late and early relapse are probably different. Investigation of the risk factors for early vs. late IH relapse is now warranted.

摘要

背景

先前并未研究过至少接受过 6 个月(在获得上市许可后开始)口服普萘洛尔治疗的婴儿血管瘤(IH)患儿在首次治疗后早期复发的相关因素。

目的

根据当前的处方指南,确定接受口服普萘洛尔治疗的 IH 患儿早期复发风险的相关因素。

方法

我们进行了一项多中心、回顾性病例对照研究,使用 Ouest Data Hub 数据库。所有于 2014 年 6 月 31 日至 2021 年 12 月 31 日期间接受至少 6 个月口服普萘洛尔治疗 IH 的患儿,且在停药后至少 3 个月进行随访的患儿均被纳入研究。IH 早期复发定义为停药后 3 个月内复发;每个病例均按照治疗起始年龄和中心进行匹配,选择 4 名(无复发)对照。使用单变量和多变量条件逻辑回归,将复发与治疗或 IH 特征之间的关系表示为比值比(OR)。

结果

共纳入 225 名患儿,其中 36 名(16%)患儿早期复发。多变量分析显示,深部 IH 成分是早期复发的危险因素[OR=8.93;95%CI:1.0-78.9,p=0.05]。普萘洛尔剂量小于 3mg/kg/日可降低早期复发的风险[OR=0.11;95%CI:0.02-0.7,p=0.02]。在停用普萘洛尔前逐渐减量与早期复发风险降低无关。

结论

晚期和早期复发的危险因素可能不同。目前有必要研究 IH 早期与晚期复发的危险因素。

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