普萘洛尔片剂治疗婴幼儿血管瘤的安全性分析

doi:10.19803/j.1672-8629.2022.07.11

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (7): 749-751.
DOI: 10.19803/j.1672-8629.2022.07.11

普萘洛尔片剂治疗婴幼儿血管瘤的安全性分析

孟康康, 王春婷, 熊玮仪

国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022

收稿日期:2022-02-11 出版日期:2022-07-15 发布日期:2022-07-12
作者简介:孟康康,女,硕士,主管药师,药品上市后监测与评价。
基金资助:
重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-003）

Safety of propranolol tablets for infantile hemangioma

MENG Kangkang, WANG Chunting, XIONG Weiyi

Center for Drug Reevaluation, NMPA/ NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Received:2022-02-11 Online:2022-07-15 Published:2022-07-12

摘要/Abstract

摘要： 目的分析普萘洛尔片剂治疗婴幼儿血管瘤的安全性风险,为临床合理用药提供参考。方法对2004年1月1日至2020年7月10日国家药品不良反应监测数据库,从建库至2020年12月1日世界卫生组织数据库、中国知网、维普网及万方数据普萘洛尔片治疗婴幼儿血管瘤的不良反应报道及国内外药品说明书进行检索与分析。结果普萘洛尔片剂治疗婴幼儿血管瘤为适应证外用药,患儿易发生低血糖、睡眠障碍等严重不良反应风险。结论建议医疗机构在用药前进行患儿体检筛查,使用中注意监测血压和心电图;药品生产企业应加强企业产品不良反应监测,及时完善药品说明书安全性信息,保障患者用药安全。

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

中图分类号:

孟康康, 王春婷, 熊玮仪. 普萘洛尔片剂治疗婴幼儿血管瘤的安全性分析[J]. 中国药物警戒, 2022, 19(7): 749-751.

MENG Kangkang, WANG Chunting, XIONG Weiyi. Safety of propranolol tablets for infantile hemangioma[J]. Chinese Journal of Pharmacovigilance, 2022, 19(7): 749-751.

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普萘洛尔片剂治疗婴幼儿血管瘤的安全性分析

Safety of propranolol tablets for infantile hemangioma

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