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Chen W, Qian H, Sun Q, Zhang S, Zhu L, Wu Y, Qian Y, Wang B, Li W. Efficacy and safety assessment of propranolol tablets vs. oral solution for infantile hemangioma: a retrospective study in China. Front Pediatr 2025; 13:1542348. [PMID: 39967746 PMCID: PMC11832506 DOI: 10.3389/fped.2025.1542348] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2024] [Accepted: 01/20/2025] [Indexed: 02/20/2025] Open
Abstract
Background Propranolol for infantile hemangiomas (IHs) is effective and relatively safe. However, propranolol has different formulations and there is no consensus on the optimal formulation for IHs. The propranolol oral solution was not used in China until 2022. Objective To evaluate the efficacy and safety of propranolol tablets and an oral solution in infants with high-risk IH. Methods A retrospective cohort study was conducted involving 234 consecutive patients with a clinical diagnosis of high-risk IH who were treated with propranolol between August 2018 and February 2023 (propranolol tablets, 168 patients; propranolol oral solution, 66 patients). All patients were assessed in the hospital at the initiation of treatment and in the outpatient setting during treatment. The Hemangioma Activity and Severity Index was used to monitor the clinical activity of the hemangioma after propranolol treatment. Results Based on the Hemangioma Activity and Severity Index, 66.52% and 69.15% improvement occurred in the propranolol tablet and oral solution groups, respectively. 23.21% of patients in the propranolol tablet group and 42.42% in the oral solution group achieved >75% score improvement (X 2 = 8.557; P = 0.003). Adverse reactions occurred in 34 (20.24%) and 11 patients (16.67%) in the propranolol tablet and oral solution groups, respectively. The most common adverse reaction in the propranolol tablet group was liver function abnormalities due to mild elevation of liver enzymes (X 2 = 4.09; P = 0.045). Conclusion Both propranolol tablets and oral solution had positive efficacy in patients with high-risk IHs, but more patients in the propranolol oral solution group achieve >75% score improvement compared to the propranolol tablet group. No life-threatening adverse reactions occurred in either group but liver function abnormalities were more likely to occur in patients treated with propranolol tablets.
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Affiliation(s)
| | | | | | | | | | | | | | | | - Wei Li
- Department of Dermatology, Children's Hospital of Soochow University, Suzhou, China
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Nishimoto A, Ogawa R, Akaishi S. Algorithm-based Management of Infantile Hemangiomas: Reducing Sequelae and Surgical Interventions. PLASTIC AND RECONSTRUCTIVE SURGERY-GLOBAL OPEN 2024; 12:e6192. [PMID: 39301308 PMCID: PMC11412708 DOI: 10.1097/gox.0000000000006192] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/02/2024] [Accepted: 07/31/2024] [Indexed: 09/22/2024]
Abstract
Background In Japan, oral propranolol (PPL) and pulsed dye laser are available for infantile hemangioma (IH) treatment without patient cost-sharing. However, no standardized algorithm exists to guide treatment selection that balances efficacy, potential side effects, and aesthetic risks. This study presents a comprehensive approach utilizing a treatment algorithm and aesthetic risk scoring system. Methods This retrospective study analyzed outcomes from 156 patients with IHs. Oral PPL was used in IH patients with functional issues, whereas the rest underwent an aesthetic risk assessment that categorized them into low-, moderate-, or high-risk groups to guide treatment choices. Final treatment decisions depended on parental preference. The outcomes of algorithm-compliant and noncompliant patients were compared statistically. Results The risk score's interrater reliability was 0.973 (95% confidence interval 0.933-0.992), with a mean intrarater reliability of 0.968 ± 0.027 and a mean evaluation time of 14.1 ± 5.0 seconds per case. Among the 156 patients, 88% pursued the algorithm-recommended treatment, whereas 12% opted for different approaches. Algorithm-compliant patients experienced significantly fewer sequelae than did noncompliant patients (5% versus 33%, P < 0.001). Compared with noncompliant patients, algorithm-compliant patients tended to require shorter treatment durations (17.9 versus 25.4 mo, P = 0.08) and fewer laser sessions (5.8 versus 7.2, P = 0.30), with a younger age at resolution (21.3 versus 29.0 mo, P = 0.08). Conclusions Aesthetic concerns can be crucial for patients with IHs. This study introduces a comprehensive IH management algorithm to reduce the sequelae requiring surgical interventions and improve patients' quality of life.
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Affiliation(s)
- Akana Nishimoto
- From the Department of Plastic and Reconstructive Surgery, Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Kanagawa, Japan
| | - Rei Ogawa
- Department of Plastic, Reconstructive and Aesthetic Surgery, Nippon Medical School Hospital; Tokyo; Japan
| | - Satoshi Akaishi
- From the Department of Plastic and Reconstructive Surgery, Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Kanagawa, Japan
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Roupakias S, Kostopoulou E, Gkentzi D, Fouzas S, Sinopidis X. Infantile hemangiomas screening modalities for primary care physicians. Pediatr Investig 2023; 7:199-205. [PMID: 37736361 PMCID: PMC10509409 DOI: 10.1002/ped4.12383] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2023] [Accepted: 04/23/2023] [Indexed: 09/23/2023] Open
Abstract
Infantile hemangiomas are the most common benign vascular tumors in children. They present a characteristic natural history of spontaneous involution after a phase of initial proliferation. A small but significant minority demonstrates incomplete regression or complications and requires prompt intervention. Prediction of the evolution of infantile hemangiomas is challenging because of their morphological and behavioral heterogeneity. The decision between referral for treatment and observation is sometimes difficult, especially among non-expert physicians, with the risk of missing the period for optimizing outcomes in case of delayed intervention. The aim of this review is to update our knowledge, especially of the primary care providers, regarding the ongoing difficulties of the early clinical evaluation of infantile hemangiomas, and to outline the importance of current practical scoring tools for the identification of the lesions which require expert consultation and referral.
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Affiliation(s)
- Stylianos Roupakias
- Department of Pediatric SurgeryUniversity of Patras School of MedicinePatrasGreece
| | - Eirini Kostopoulou
- Department of PediatricsUniversity of Patras School of MedicinePatrasGreece
| | - Despoina Gkentzi
- Department of PediatricsUniversity of Patras School of MedicinePatrasGreece
| | - Sotirios Fouzas
- Department of PediatricsUniversity of Patras School of MedicinePatrasGreece
| | - Xenophon Sinopidis
- Department of Pediatric SurgeryUniversity of Patras School of MedicinePatrasGreece
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Chiramel M, Katakam B, Gulati R, Gupta M, Munisamy M, S. Ranugha PS, Seetharam KA. IADVL SIG pediatric dermatology (academy) recommendations on Hemangioma of Infancy (HOI). Indian Dermatol Online J 2023; 14:172-186. [PMID: 37089858 PMCID: PMC10115319 DOI: 10.4103/idoj.idoj_52_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/27/2022] [Revised: 12/09/2022] [Accepted: 12/13/2022] [Indexed: 03/12/2023] Open
Abstract
Hemangioma of infancy (HOI) is a benign vascular proliferation. Though resolution is the norm, potential complications make an accurate diagnosis and early management of importance. The Indian association of dermatologists, venereologists and leprologists (IADVL) special interest group (SIG) paediatric dermatology in association with IADVL academy did an extensive analysis of the literature on the clinical features, diagnosis, and management of HOI published between 2010 and 2021. Online meetings were conducted from February 2021 to March 2022 to reach a consensus on these recommendations which are made from an Indian perspective.
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Ren J, Tuan H, Huang C, Shu D, Chen D, Zhou EY, Liu D, Tu P, Zhao Y. A proposed scoring system for facial port-wine stain evaluation: Facial port-wine stain area and severity index. J Cosmet Dermatol 2022; 21:2931-2938. [PMID: 34741790 DOI: 10.1111/jocd.14574] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2021] [Revised: 10/11/2021] [Accepted: 10/18/2021] [Indexed: 12/31/2022]
Abstract
BACKGROUND Port-wine stain (PWS) is a congenital capillary malformation that often occurs on the face. Feasible and quantitative evaluation of facial port-wine stain (FPWS) can significantly impact its clinical management and aid in future research. AIM To develop and validate an easy-to-use scoring system for FPWS evaluation. METHODS A facial port-wine stain area and severity index (FSASI) scoring system was proposed. To determine the FSASI score, the face was divided into four regions: forehead, right malar, left malar, and perioral. The severity of FPWS in each region was evaluated by three factors: percentage of the area affected, lesion color, and thickness. To evaluate the intra- and inter-rater reliability of FSASI, two separate FSASI assessments on 111 clinical pictures were conducted by each rater in a one-week interval, and the results from 6 independent raters at different time points were compared. Validity of the FSASI scores was assessed by comparing it with physician global assessment (PGA) and traditional classification data. Validity of the area and color elements of FSASI was also determined. The changes in FSASI scores after vascular-targeted photodynamic therapy (V-PDT) were analyzed to evaluate the treatment effect. RESULTS The FSASI scoring system showed good intra- and inter-rater reliability (ICC >0.75, p < 0.001) and was found to be comparable to PGA scores (Spearman's r = 0.752-0.907, p < 0.001) and traditional classification data (Spearman's r = 0.426-0.662, p < 0.001). Efficacy analysis indicated that FSASI scores decreased after V-PDT treatment. CONCLUSION The results of this study demonstrated the reliability and validity of FSASI, which may be applied to assess the severity of FPWS and to evaluate treatment effects in clinical practice and research.
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Affiliation(s)
- Jie Ren
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Hsiaohan Tuan
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Chenyu Huang
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Dan Shu
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Dian Chen
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Eray Yihui Zhou
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Dehua Liu
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
| | - Ping Tu
- Department of Dermatology, First Hospital, Peking University, Beijing, China
| | - Yi Zhao
- Department of Dermatology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.,Photomedicine Laboratory, Institute of Precision Medicine, Tsinghua University, Beijing, China
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Guroo S, Akhtar M, Goel A, Rabbani S, Alim S, Haseen M, Abbasi A. Effect of propranolol in cutaneous and intracavitary hemangiomas. INDIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY 2022. [DOI: 10.4103/ijves.ijves_35_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022] Open
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Bae KN, Shin K, Kim HS, Kim BS, Kim MB, Ko HC. Infantile Hemangiomas with Minimal and Arrested Growth: Clinical Features and Treatment Outcomes with 0.5% Topical Timolol Maleate. Ann Dermatol 2021; 33:448-455. [PMID: 34616126 PMCID: PMC8460486 DOI: 10.5021/ad.2021.33.5.448] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2020] [Revised: 02/22/2021] [Accepted: 03/02/2021] [Indexed: 11/23/2022] Open
Abstract
Background A minority of infantile hemangiomas showing minimal or arrested growth (IH-MAGs) have been recognized in the literature. Nevertheless, the clinical features and treatment outcomes of IH-MAGs have not been well investigated. Objective This study aimed to understand the clinical characteristics of IH-MAGs better and their response to treatment with topical timolol maleate. Methods We retrospectively reviewed medical records and clinical images of patients with IH-MAGs. Treatment response with topical timolol was assessed in both IH-MAGs and classic infantile hemangiomas (IHs) groups. Results Of the 1,038 patients with IHs, only 31 (3.0%) were diagnosed with IH-MAGs. Lesions with non-proliferative components were more frequently distributed in the lower half of the body (61.5%) than those with proliferative components (16.7%). In 14 patients treated with topical timolol, the global assessment scale showed more significant and rapid improvement than in those with classic IHs. Conclusion Although the prevalence of IH-MAGs may be relatively low, understanding their clinical features will help in differential diagnosis. Furthermore, these type of lesions might be more responsive to topical timolol than classic IHs.
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Affiliation(s)
- Kyung-Nam Bae
- Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea
| | - Kihyuk Shin
- Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea
| | - Hoon-Soo Kim
- Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea
| | - Byung-Soo Kim
- Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea
| | - Moon-Bum Kim
- Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea
| | - Hyun-Chang Ko
- Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea.,Department of Dermatology, Pusan National University Yangsan Hospital, Busan, Korea.,Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea
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Chitpiromsak K, Techasatian L, Jetsrisuparb C. Utility of the Infantile Hemangioma Referral Score (IHReS) as a decision-making tool for referral to treatment. BMJ Paediatr Open 2021; 5:e001230. [PMID: 34604545 PMCID: PMC8444243 DOI: 10.1136/bmjpo-2021-001230] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/20/2021] [Accepted: 09/01/2021] [Indexed: 11/25/2022] Open
Abstract
BACKGROUND The general paediatricians and primary care physicians sometimes face immense difficulty in referral judgements regarding which infantile hemangiomas (IHs) require referrals and when is the appropriate time to refer IHs for treatment. This resulted in the treatment being delayed beyond IHs' critical timeframe. The Infantile Hemangioma Referral Score (IHReS) has been recently developed, with the aim to solve this problem. OBJECTIVES The objective of the present study is to evaluate the reliability of IHReS and to assess the possibility of using this instrument in our country where a similar problem of delaying treatment of IHs is currently existing. METHODS The present study was a prospective, cross-sectional study. Thirteen selected clinical cases were used to assess the reliability of IHReS among physicians who may have had the chance to deal with patients with IHs. The target physicians across the country were asked to participate in the study via an online platform (Google Forms) to decide whether to refer patients with IHs for treatment or observe. There were 3 steps of assessment: step 1, usual practice evaluation; step 2, using IHReS; step 3, retesting by using IHReS. RESULTS Substantial agreement was observed after using IHReS (step 2) for interrater reliability, with Fleiss' Kappa values of 0.80 and 0.78 among IH experts and non-expert physicians, respectively. Regarding repeatability, in the test-retest assessments, Cohen's Kappa coefficient values revealed almost perfect agreement in intrarater repeatability for both experts and non-expert physicians (1.00). CONCLUSION IHReS is a simple, easy-to-assess tool for non-expert physicians. The benefit in the increase of interrater agreement was found in both IH experts and non-expert physicians. It has had the reliability to be used in making referral decisions regarding patients with IH for treatment among Thai physicians. Using IHReS can improve clinical outcomes by identifying which patient needs early intervention to minimise the possible complications.
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Tripathy D. Commentary: Propranolol for infantile hemangiomas — The intralesional route. Indian J Ophthalmol 2019; 67:1981-1982. [PMID: 31755432 PMCID: PMC6896536 DOI: 10.4103/ijo.ijo_1085_19] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
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Moyakine AV, Herwegen B, van der Vleuten CJM. Use of the Hemangioma Severity Scale to facilitate treatment decisions for infantile hemangiomas. J Am Acad Dermatol 2017; 77:868-873. [PMID: 28818436 DOI: 10.1016/j.jaad.2017.06.003] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2017] [Revised: 05/30/2017] [Accepted: 06/02/2017] [Indexed: 10/19/2022]
Abstract
BACKGROUND The Hemangioma Severity Scale (HSS) assesses the severity of an infantile hemangioma (IH). OBJECTIVE First, to compare HSS scores between patients with IH for whom propranolol treatment was indicated at their first visit and those who were not treated. Second, to assess suitable cutoff values for the need for propranolol treatment. METHOD All patients with IH who attended our tertiary referral center since 2008 and were 0 to 6 months of age at their first visit were included. They were divided into propranolol and no-propranolol groups on the basis of choice of treatment at their first visit. HSS scores were assessed, and median scores were compared. RESULTS A total of 657 children (342 in the propranolol group) were included. The median HSS score (25th-75th percentile) in the propranolol group was 10 (range, 8-14) compared with 7 (range, 4-9) in the no-propranolol group (P < .001). Cutoff values of 6 or lower (no indication for treatment) and 11 or higher (indication for treatment) resulted in 94% sensitivity and 89% specificity, respectively. LIMITATIONS HSS scoring was not completely blinded. CONCLUSION The HSS with cutoff values of 6 or lower and 11 or higher could be used as a triage tool for propranolol treatment. Patient age, IH type, and parental preference may also contribute to treatment decisions.
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Affiliation(s)
- Andre Vadimovich Moyakine
- Department of Dermatology, Hecovan Expertise-Center for Hemangioma and Vascular Malformations, Radboud University Medical Center, Nijmegen, The Netherlands.
| | - Bjorn Herwegen
- Department of Dermatology, Hecovan Expertise-Center for Hemangioma and Vascular Malformations, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Catharina Joanna Maria van der Vleuten
- Department of Dermatology, Hecovan Expertise-Center for Hemangioma and Vascular Malformations, Radboud University Medical Center, Nijmegen, The Netherlands
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Janmohamed SR, Oranje AP. Scoring systems for infantile hemangioma: the Hemangioma Activity Score versus the Hemangioma Activity and Severity Index. Int J Dermatol 2016; 55:e416-7. [PMID: 26872855 DOI: 10.1111/ijd.13242] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/23/2015] [Accepted: 11/08/2015] [Indexed: 11/27/2022]
Affiliation(s)
- Sherief R Janmohamed
- Department of Dermatology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Brussels, Belgium
| | - Arnold P Oranje
- Department of Dermatology, Dermicis Skin Hospital, Alkmaar, and (Kinder)huid, Rotterdam, The Netherlands.
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Moyakine AV, Vleuten CJMVD. Propranolol for infantile hemangioma: Current state of affairs. World J Dermatol 2016; 5:4-16. [DOI: 10.5314/wjd.v5.i1.4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/27/2015] [Revised: 10/19/2015] [Accepted: 12/14/2015] [Indexed: 02/06/2023] Open
Abstract
Infantile hemangioma (IH) is the most common benign tumor seen in infancy. This review provides up-to-date information on the pathophysiology, variations in clinical presentation, and natural history of IH, elaborating on associated anomalies, such as PHACE(S) syndrome and LUMBAR syndrome. Because of the benign and self-limiting characteristics seen in more than 90% of cases of IH, a conservative approach is usually chosen. However, some circumstances, such as ulceration, vision loss, breathing difficulties, or potential disfigurement, will require treatment during the proliferative phase. For decades, treatment of IH has primarily consisted of corticosteroids or surgery. Since 2008, propranolol has become the treatment of first choice. In this article, we bring to light the crucial changes in the treatment of IH over the past years. To date, there is still a lack of data on the possible long-term effects of propranolol treatment in young infants. A theoretical probability of the central nervous system being affected (that is, impairment of short- and long-term memory, psychomotor function, sleep quality, and mood) has recently been suggested. This review highlights research topics concerning these long-term adverse effects. Finally, information is provided on the potential instruments to measure IH severity and activity in clinical trials and/or in clinical practice and the recently developed and first-validated IH-specific quality-of-life questionnaire.
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