关键词: 普萘洛尔, 血管瘤, 药品不良反应, 监管措施, 婴幼儿, 低血糖, 睡眠障碍

Abstract: Objective To analyze the risk of propranolol tablets in the treatment of infantile hemangioma so as to provide reference for clinical rational drug use. Methods The reports about adverse drug reactions (ADR) induced by propranolol tablets for infantile hemangioma that were collected in China adverse drug reaction database from January 1, 2004 to July 10, 2020 and those collected in WHO Vigilyze, CNKI, VIP and Wanfang database from inception to December 1, 2020 were retrieved and analyzed, while related domestic and foreign drug Instructions were also reviewed. Results Treatment of infantile hemangioma with propranolol tablets was off-label, and children were vulnerable to the risk of serious adverse reactions such as hypoglycemia and sleep disturbance. Conclusion It is recommended that medical institutions should carry out physical examinations and screening for children before prescribing this drug and monitor blood pressure and heart rate during medication. Drug manufacturers should make more effort to monitor adverse reactions of their products, improve the information on safety in drug inserts in time, and ensure the safety of patients' medication.

Key words: propranolol, hemangioma, adverse drug reaction, regulatory measure, infantile, hypoglycemia, sleep disturbance