Possibilities of medical treatment of infantile hemangiomas in Russia

Introduction. Infantile hemangiomas (IH) are the most common benign vascular tumor of children of the first year and are an interdisciplinary problem of neonatologists, pediatricians, pediatric cardiologists, oncologists, pediatric surgeons, dermatologists. Depending on the age of child, phase of pathological process, size, and localization of the IH, the management tactics of such children can be conservative (pharmaceuticals therapy) or invasive (laser therapy, surgical methods). Laser therapy with a pulsed dye laser has proven itself well to correct and minimize residual phenomena because of spontaneous involution and after the completion of pharmaceuticals treatment.
The purpose of the study is to analyze the experience of using Hemangiol® (oral solution) for the treatment of children with IH, obtained in 10 medical hospitals in 6 cities of Russia.
Materials and methods. Treatment with Hemangiol® was carried out in 6 cities of Russia on the basis of 10 medical hospitals (Children’s City
Clinical Hospital named after Z.A. Bashlyaeva of Moscow City Health Department, Research Institute of Pediatric Oncology and Hematology of N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia (Moscow), Russian Children’s Clinical Hospital of the N.I. Pirogov Russian National Research Medical University, Ministry of Health of Russia (Moscow), Children’s City Clinical Hospital named after N.F. Filatov of Moscow City Health Department, Saint Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological) (S.-Petersburg), Almazov National Medical Research Centre, Ministry of Health of Russia (S.-Petersburg), Rostov Regional Clinical Hospital (Rostov-on-Don), Stavropol Regional Children’s Clinical Hospital (Stavropol), Samara Regional Clinical Hospital named after V.D. Seredavin, Children’s Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan (Kazan) in the Departments of Pediatric Cardiology, Surgery, Oncology, Pediatrics from January 2020 to December 2021. Therapy with Hemangiol® was received by 49 children with IH for at least 3 months. Before the start of treatment, the patients’ heart rate and blood pressure were measured, general and biochemical blood tests were performed, electrocardiography and ultrasound IH were performed. According to the indications, ultrasound of the liver and thyroid gland was performed to determine the parameters of the thyroid status. Before the start of therapy and during dynamic observation, photo documentation was performed against the background of treatment. In the absence of contraindications to treatment, Hemangiol® was prescribed. During a six-month course of treatment with Hemangiol®, effectiveness was evaluated based on the results of a clinical examination and based on photographs. The appearance of possible adverse reactions was monitored.
Results. In 33 (67.3 %) children with IH, therapy with Hemangiol® was completed within 6 months. The effect of treatment in the form of a pronounced regression of vascular tumor was achieved in 25 (75.8 %) of 33 patients. In 16 (32.7 %) of 49 children, treatment with Hemangiol® was continued for more than 6 months. The first symptoms of improvement were observed from the second to 10 days after the start of Hemangiol® therapy in 45 patients, which was (91.8 %). Rebound syndrome (recurrence of IH) was detected in 2 (6.0 %) of 33 children who completed therapy. Transit adverse reactions (decreased heart rate, increased excitability, lethargy) on therapy of Hemangiol® were observed in 8 (16.3 %) children. The duration of therapy with Hemangiol® depended on the prevalence, the depth of the IH lesion, as well as on the presence of prematurity in a child with IH (r = 0.533, p < 0.05). Successful laser treatment with a pulsed laser on a dye after the completion of systemic Hemangiol® therapy, were on 5 children of Research Institute of Pediatric Oncology and Hematology at N.N. Blokhin National Medical Research Centre of Oncology, Ministry of Health of Russia.
Conclusion. The results of the using of Hemangiol® as a modern means of systemic pharmacotherapy of IH therapy in 10 medical hospitals in 6 cities of Russia have demonstrated its high efficiency and safety.

1. Munden A., Butschek R., Tom W.L., Marshall J.S., Poeltler D.M., Krohne S.E., Alió A.B., Ritter M., Friedlander D.F., Catanzarite V., Mendoza A., Smith L., Friedlander M., Friedlander S.F. Prospective study of infantile haemangiomas: incidence, clinical characteristics and association with placental anomalies. Br J Dermatol. 2014;170(4):907–13. doi: 10.1111/bjd.12804.

2. Krowchuk D.P., Frieden I.J., Mancini A.J., Darrow D.H., Blei F., Greene A.K., Annam A., Baker C.N., Frommelt P.C., Hodak A., Pate B.M., Pelletier J.L., Sandrock D., Weinberg S.T., Whelan M.A.; SUBCOMMITTEE ON THE MANAGEMENT OF INFANTILE HEMANGIOMAS. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019;143(1):e20183475. doi: 10.1542/peds.2018-3475.

3. Hoeger P.H., Harper J.I., Baselga E., Bonnet D., Boon L.M., Ciofi Degli Atti M., El Hachem M., Oranje A.P., Rubin A.T., Weibel L., Léauté-Labrèze C. Treatment of infantile haemangiomas: recommendations of a European expert group. Eur J Pediatr. 2015;174(7):855–65. doi: 10.1007/s00431-015-2570-0.

4. Bauland C.G., Lüning T.H., Smit J.M., Zeebregts C.J., Spauwen P.H.M. Untreated hemangiomas: growth pattern and residual lesions. Plast Reconstr Surg. 2011;127(4):1643–8. doi: 10.1097/PRS.0b013e318208d2ac.

5. Belysheva T.S., Kotlukova N.P., Valiev T.T., Konstantinova N.K., Telezhnikova N.D., Lavrova T.R., Gazalieva L.R. Results of infantile hemangioma laser therapy in children with persistent residual signs after systemic propranolol therapy: clinical cases. Voprosy sovremennoi pediatrii. = Current Pediatrics. 2021;20(5):418–25. (In Russ.).

6. Kotlukova N.P., Belysheva T.S., Valiev T.T., Konstantinova N.K., Telezhnikova N.D., Lavrova T.R. Interdisciplinary approach to the treatment of infantile hemangiomas. Pediatriya. Zhurnal im. G.N. Speranskogo. = Pediatria. Journal named after G.N. Speransky. 2021;100(3): 174–82. (In Russ.).

7. Overview of the speech at the II Joint Congress of NODGO and RODO: “For the fi rst time in Russia. Clinical recommendations for infantile hemangiomas”. Rossiyskiy zhurnal detskoy gematologii i onkologii. = Russian Journal of Pediatric Hematology and Oncology. 2022;9(1):72–3. (In Russ.).

8. Clinical guidelines for the treatment of hematological and oncological diseases in children. National Society of Pediatric Hematologists and Oncologists. [Electronic resource]: https://nodgo.org/%D1%80%D0%B5%D0%BA%D0%BE%D0%BC%D0%B5%D0%BD%D0%B4%D0%B0%D1%86%D0%B8%D0%B8 (appeal date 20.05.2022). (In Russ.).

9. Инструкция по медицинскому применению препарата Гемангиол®.

10. Léauté-Labrèze C., Hoeger P., Mazereeuw-Hautier J., Guibaud L., Baselga E., Posiunas G., Phillips R.J., Caceres H., Lopez Gutierrez J.C., Ballona R., Friedlander S.F., Powell J., Perek D., Metz B., Barbarot S., Maruani A., Szalai Z.Z., Krol A., Boccara O., Foelster-Holst R., Febrer Bosch M.I., Su J., Buckova H., Torrelo A., Cambazard F., Grantzow R., Wargon O., Wyrzykowski D., Roessler J., Bernabeu-Wittel J., Valencia A.M., Przewratil P., Glick S., Pope E., Birchall N., Benjamin L., Mancini A.J., Vabres P., Souteyrand P., Frieden I.J., Berul C.I., Mehta C.R., Prey S., Boralevi F., Morgan C.C., Heritier S., Delarue A., Voisard J.J. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015;372(8):735–46. doi: 10.1056/NEJMoa1404710.

11. Thoumazet F., Léauté-Labrèze C., Colin J., Mortemousque B. Effi cacy of systemic propranolol for severe infantile haemangioma of the orbit and eyelid: a case study of eight patients. Br J Ophthalmol. 2012;96(3):370–4. doi: 10.1136/bjophthalmol-2011-300047.

12. Konstantinova N.K., Trunina I.I., Telezhnikova N.D., Lavrova T.R., Grishkin A.N., Karelina E.V. Modern strategy and tactics of managing children with infantile hemangiomas. Praktika pediatra. = Pediatric Practice. 2020;4:4–12. (In Russ.).

13. Kotlukova N.P., Konstantinova N.K., Trunina I.I., Telezhnikova N.D., Poletaeva E.V. Modern systemic pharmacotherapy of infantile hemangiomas. Praktika pediatra. = Pediatric Practice. 2021;1:52–6. (In Russ.).