康妇消炎栓给药途径相关安全风险分析及思考  

Risks of Kangfuxiaoyan suppository due to routes of administration

作　　者：朱兰 金哲[2] 刘丽红[3] 钟露苗 刘小军 ZHU Lan;JIN Zhe;LIU Lihong;ZHONG Lumiao;LIUXiaojun(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100022,China;Department of Gynecology,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Hunan Center for Drug Evaluation,Changsha Hunan 410000,China;Baoding No.1 Hospital of TCM,Baoding Hebei 071000,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,北京100022 [2]北京中医药大学东方医院妇科,北京100078 [3]中国中医科学院中医药信息研究所,北京100700 [4]湖南省药品审评与不良反应监测中心,湖南长沙410000 [5]保定市第一中医院老年病科,河北保定071000

出　　处：《中国药物警戒》2023年第3期306-310,共5页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2018YFC1707409);国家自然科学基金资助项目(82274684)。

摘　　要：目的分析康妇消炎栓给药途径相关安全风险,为其安全合理使用提供参考。方法总结康妇消炎栓不良反应监测数据、国内文献报道及药品监管机构采取的风险管理等资料,分析康妇消炎栓经阴道给药的不良反应情况,分析其存在的风险。结果2004年1月1日至2022年1月31日,国家药品不良反应监测系统共收到康妇消炎栓不良反应报告1916例。康妇消炎栓为直肠栓,但有215例报告给药途径为阴道给药。对比分析显示,与直肠给药相比,阴道给药报告相关的用药部位疼痛,外阴阴道瘙痒、不适、灼烧感,过敏反应等占比更高。文献分析结果显示,经阴道给药可能影响其制剂疗效,并可能引起阴道刺激等不良反应。结论根据药品不良反应评估结果,国家药品监督管理局已对康妇消炎栓药品说明书进行统一修订,药品上市许可持有人也应开展与医务人员和患者的沟通和教育,进一步控制康妇消炎栓阴道给药相关安全风险。Objective To analyze the risk of Kangfuxiaoyan suppository related to routes of administration in order to provide reference for clinical rational drug use.Methods The cases of adverse drug reactions(ADR)reported in the national ADR monitoring system,related domestic literature,and precautions taken in China were summarized.The risks of Kangfuxiaoyan suppository due to vaginal administration were analyzed.Results A total of 1916 cases of ADR related to Kangfuxiaoyan suppository were collected from the national adverse drug reaction monitoring system between 2004 and 2022.Kangfuxiaoyan suppository should have been administered rectally,but there were 215 cases of ADR caused by vaginal administration.The incidence of pain at the site of application,vulvovaginal pruritus,vulvovaginal discomfort,vulvovaginal burning sensation and allergic reactions was higher in these cases of ADR.Vaginal administration could affect the efficacy and cause such adverse reactions as vaginal irritation.Conclusion The drug label of Kangfuxiaoyan suppository has been upgraded under the requirement of National Medical Products Administration(NMPA).Drug marketing authorization holders should communicate more with health care providers and patients to control the safety risks related to vaginal administration of Kangfuxiaoyan suppository.

关 键 词：康妇消炎栓 直肠栓 阴道给药 药品不良反应 监管措施 

分 类 号：R994.11[医药卫生—毒理学]