A Randomised Study Examining the Utility of Lauromacrogol Foam Sclerotherapy vs Pingyangmycin in Treatment of Pediatric Lymphatic Malformations --A Single Center Report From China.

IF 2.5 2区 医学 Q1 PEDIATRICS
Dan Song, Liang Wang, Jing Li, Xin Zhang, Jie Zhou, Lei Guo
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Abstract

Objective: To evaluate the efficacy and safety of ultrasound-guided percutaneous lauromacrogol foam sclerotherapy for lymphatic malformations in children.

Methods: In this open-label randomized controlled trial, children with lymphatic malformations treated at the Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital) between January 2022 and September 2023 were enrolled. Participants were randomly assigned using a random number table to receive either pingyangmycin or lauromacrogol foam sclerotherapy. All procedures were performed under ultrasound guidance. Cystic fluid was aspirated, and the sclerosant was injected after confirming a fluid-free dark area. Clinical efficacy, adverse events, and other outcomes were recorded and compared between groups.

Results: A total of 238 children were enrolled: 126 in the pingyangmycin group and 112 in the lauromacrogol group. No significant differences in efficacy were observed between the two groups overall or across subtypes (macrocystic, mixed, or microcystic; all P > 0.05). However, the lauromacrogol group required fewer treatment sessions (1.35 ± 0.3 vs 2.19 ± 0.7, P < 0.05) and experienced fewer adverse events (12.5% vs 38.9%, P < 0.05) compared with the pingyangmycin group.

Conclusion: Ultrasound-guided lauromacrogol foam sclerotherapy is a safe and effective treatment for pediatric lymphatic malformations. Compared with pingyangmycin, it avoids the risks of antitumor drug toxicity, reduces the number of treatment sessions, and lowers adverse event incidence, offering greater clinical value in children.

一项随机研究考察了聚月桂醇泡沫硬化疗法与平阳霉素治疗儿童淋巴畸形的疗效——来自中国的单中心报告。
目的:评价超声引导下经皮聚月桂醇泡沫硬化治疗儿童淋巴畸形的疗效和安全性。方法:在这项开放标签随机对照试验中,纳入了2022年1月至2023年9月在山东大学附属儿童医院(济南儿童医院)治疗的淋巴畸形儿童。参与者使用随机数字表随机分配,接受平阳霉素或聚月桂醇泡沫硬化疗法。所有手术均在超声引导下进行。抽出囊性液体,在确认无液体的暗区后注射硬化剂。记录两组间的临床疗效、不良事件及其他结果并进行比较。结果:共纳入238例儿童:平阳霉素组126例,月桂醇组112例。两组在整体或不同亚型(大囊性、混合性或微囊性;均P < 0.05)的疗效无显著差异。然而,与平阳霉素组相比,聚月桂醇组所需的治疗时间(1.35±0.3 vs 2.19±0.7,P < 0.05)较少,不良事件发生率(12.5% vs 38.9%, P < 0.05)较少。结论:超声引导下聚月桂醇泡沫硬化治疗小儿淋巴畸形是一种安全有效的治疗方法。与平阳霉素相比,它避免了抗肿瘤药物毒性的风险,减少了治疗次数,降低了不良事件的发生率,在儿童中具有更大的临床价值。
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来源期刊
CiteScore
1.10
自引率
12.50%
发文量
569
审稿时长
38 days
期刊介绍: The journal presents original contributions as well as a complete international abstracts section and other special departments to provide the most current source of information and references in pediatric surgery. The journal is based on the need to improve the surgical care of infants and children, not only through advances in physiology, pathology and surgical techniques, but also by attention to the unique emotional and physical needs of the young patient.
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