{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T18:32:38Z","timestamp":1766428358179,"version":"3.41.0"},"reference-count":29,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2017,6,30]],"date-time":"2017-06-30T00:00:00Z","timestamp":1498780800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Maruho"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatrics International"],"published-print":{"date-parts":[[2017,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>There have been few reports on the efficacy and safety of oral propranolol at 3 mg\/kg\/day for infantile hemangioma (<jats:styled-content style=\"fixed-case\">IH<\/jats:styled-content>) in Japanese patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A multicenter, open\u2010label phase<jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>study was conducted to evaluate the efficacy and safety of oral propranolol solution in Japanese infants aged 35\u2013150 days with proliferating<jats:styled-content style=\"fixed-case\">IH<\/jats:styled-content>. Thirty\u2010two patients were enrolled in the study, received propranolol solution for 24 weeks at 3 mg\/kg\/day, and completed the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The success rate (complete or nearly complete resolution) at week 24 (primary endpoint) was 78% (95%<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: 60\u201391%). The improvement rate since the previous visit was 100% (32\/32) after week 5. Overall, the<jats:styled-content style=\"fixed-case\">IH<\/jats:styled-content>surface area, maximum diameter, and color intensity all decreased over time. Consistency in assessment between the centralized and the investigator on\u2010site assessments was observed in 26 patients. Of the 32 patients, 11 needed further treatment other than the study drug. The incidence of adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>) and drug\u2010related<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>was 97% and 31%, respectively.<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>that occurred in \u2265two patients were either typical of propranolol use (such as blood pressure decrease) or common events in infants.<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>that resulted in dose reduction were observed in two patients, but no serious<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>or<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>that led to study drug discontinuation were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Oral propranolol solution at 3 mg\/kg\/day is effective and safe in Japanese<jats:styled-content style=\"fixed-case\">IH<\/jats:styled-content>patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ped.13318","type":"journal-article","created":{"date-parts":[[2017,4,28]],"date-time":"2017-04-28T16:18:23Z","timestamp":1493396303000},"page":"869-877","source":"Crossref","is-referenced-by-count":23,"title":["Efficacy and safety of oral propranolol for infantile hemangioma in Japan"],"prefix":"10.1111","volume":"59","author":[{"given":"Tsuyoshi","family":"Kaneko","sequence":"first","affiliation":[{"name":"Department of Surgical Specialties National Center for Child Health and Development Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoru","family":"Sasaki","sequence":"additional","affiliation":[{"name":"Center for Vascular Anomalies KKR Tonan Hospital Hokkaido Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoko","family":"Baba","sequence":"additional","affiliation":[{"name":"Department of Dermatology Kanagawa Children's Medical 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