ArticleVascular health and risk management2026
Short-Term Efficacy and Safety of Topical Sirolimus Gel in Pediatric Superficial Microcystic Lymphatic Malformations: A Single-Center Interventional Study of 30 Patients.
Article in Vascular health and risk management, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: To evaluate the efficacy and safety of 0.2% topical sirolimus gel for pediatric superficial microcystic lymphatic malformations (LMs). Methods: This single-center interventional study included 30 pediatric patients (14 males and 16 females; aged 2-15 years) with superficial microcystic lymphatic malformations. All patients received 0.2% topical sirolimus gel twice daily for 12 weeks according to a predefined treatment and follow-up protocol. Clinical efficacy was assessed at baseline and week 12 using clinical examination, standardized photography, symptom scores, and available imaging findings, together with a four-grade physician-assessed response scale. Adverse events were monitored throughout treatment, and blood sirolimus concentrations were measured at weeks 4 and 12. Results: All patients showed lesion reduction, with an overall response rate of 96% (29/30). At week 12, efficacy was graded as IV in 10 patients, III in 11, II in 8, and I in 1. Among patients with pain symptoms, pain scores decreased significantly after treatment (2.88 ± 0.78 vs 1.18 ± 0.88; P < 0.05). In 10 patients with measurable lesions, maximum lesion diameter decreased significantly from 3.22 ± 1.36 cm to 1.89 ± 1.33 cm (P < 0.05). Only mild local adverse effects were observed, and blood sirolimus concentrations remained below 2.0 ng/mL in all patients. Conclusion: Topical sirolimus gel demonstrated favorable efficacy and safety for pediatric superficial microcystic LMs.
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