首页|基于不同年龄段人群的金莲清热制剂不良反应报告分析

基于不同年龄段人群的金莲清热制剂不良反应报告分析

扫码查看
目的 探讨不同年龄段人群使用金莲清热制剂的相关安全性风险,为临床合理用药提供参考.方法 结合福建省药品不良反应监测数据库(2004年1月—2023年6月)、国内文献报道及药品监管机构采取的风险管理等资料,分析不同年龄段人群使用金莲清热制剂的不良反应情况,分析其可能存在的风险.结果 金莲清热制剂药品不良反应主要涉及15岁以下的儿童,多在用药当日发生,最突出的是以腹泻为主的胃肠道反应和以皮疹、瘙痒为主的过敏反应.结论 金莲清热制剂不良反应一般较轻,大多数不需要特殊处理,但需关注儿童用药安全.根据药品安全性评价结果,国家药品监督管理局已发布对金莲清热制剂药品说明书的修订要求,药品上市许可持有人按要求修订说明书的同时还应积极开展与医务人员和患者的沟通和宣贯教育,保障患者用药安全.
Adverse reactions of Jinlian Qingre preparations in different age groups
Objective To determine the safety risks associated with the use of Jinlian Qingre preparations in different age groups,and to provide reference for rational drug use.Methods The adverse drug reactions(ADR)reported in the Fujian ADR monitoring Database(Jan 2004-June 2023),related domestic literature,and precautions taken in China were summarized.The risks of Jinlian Qingre preparations among different age groups were analyzed.Results The ADRs of Jinlian Qingre preparations mainly occurred among children under 15 years old,mostly on the firstday of medication use,with the most prominent being gastrointestinal reactions(diarrhea)and allergic reactions(rash and itching).Conclusion The ADRs of Jinlian Qingre preparations are generally mild,and most do not need special treatment.However,attention should be paid to the children of medication safety.Based on the evaluation,the drug label of Jinlian Qingre preparations has been modified to ensure the safety medication use.

Jinlian Qingre preparationadverse drug reactiondrug rational use

张纾、林翼旻、张玲萍、黄榕珍

展开 >

福建省药品审评与监测评价中心,福州 350003

金莲清热制剂 不良反应 合理用药

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(7)
  • 15