羟苯磺酸钙口服制剂上市后安全性分析  

Risks of Calcium Dobesilate Preparations to Safety

作　　者：孟康康 汤韧 MENG Kangkang;TANG Ren(Center for Drug Reevaluation,NMPA/NMPA Key,Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China)

机构地区：[1]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,北京100076

出　　处：《中国药物警戒》2024年第11期1288-1292,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的分析羟苯磺酸钙口服制剂安全性信息,为临床合理用药提供参考。方法对2004年1月1日至2023年3月31日国家药品不良反应监测数据库中羟苯磺酸钙口服制剂的ADR发生特点及临床表现进行汇总;对2000年1月1日至2024年5月31日国内外文献数据库相关ADR报道进行整理;对国内外药品说明书进行分析。结果2004年1月1日至2023年3月31日,共有羟苯磺酸钙制剂ADR病例报告3815例,其中严重病例182例,严重病例报告中,皮肤损害报告较多;文献报道中毒性表皮坏死松解症较突出,且患者均伴随有肾功能损害。结论羟苯磺酸钙口服制剂可致严重皮肤损害,尤其肾功能损害需透析的患者需慎用,医疗机构应关注此风险。药品上市许可持有人应加强ADR监测,及时完善羟苯磺酸钙口服制剂说明书安全性信息。Objective To analyze the safety information of oral preparations of Calcium Dobesilate and provide reference for rational clinical drug use.Methods Individual cases of adverse drug reactions reported in China adverse drug reaction(ADR)database between January 1,2004 and March 31,2023,domestic and international literature published from January 1,2000 to March 31,2023,domestic and international drug specifications were analyzed.Results From January 1,2004 to March 31,2023,there were a total of 3815 ADR reports of Calcium Dobesilate preparations in the database,involving 182 serious cases.in the reports of severe cases,skin damage was reported more frequently;Toxic epidermal necrolysis is more prominent in the literature,and the patients were accompanied by renal impairment.Conclusion Calcium Dobesilate oral preparation may cause serious skin damage,especially in patients with renal impairment requiring dialysis,and Medical institutions should pay attention to this risk.Marketing authorization holders should strengthen the monitoring of adverse reactions and update the information on safety in drug labels in time.

关 键 词：羟苯磺酸钙 药品不良反应 风险 发热 中毒性表皮坏死松解症 监管措施 说明书 

分 类 号：R972[医药卫生—药品] R994.11[医药卫生—药学]