187例百癣夏塔热片相关药品不良反应分析  

Analysis on 187 Cases of Baixuan Xiatare Tablets-Related Adverse Drug Reactions

作　　者：滕威[1,2,3] 康莹莹 焦敏 沈皓 龚褔恺[1,3] 于鲁海 吴建华 TENG Wei;KANG Yingying;JIAO Min;SHEN Hao;GONG Fukai;YU Luhai;WU Jianhua(Dept.of Pharmacy,People’s Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830001,China;Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region,Urumqi 830001,China;Xinjiang Uygur Autonomous Region Drug Use Monitoring and Clinical Comprehensive Evaluation Center,Urumqi 830001,China)

机构地区：[1]新疆维吾尔自治区人民医院药学部,乌鲁木齐830001 [2]新疆维吾尔自治区临床药学研究所,乌鲁木齐830001 [3]新疆维吾尔自治区药品使用监测与临床综合评价中心,乌鲁木齐830001

出　　处：《中国医院用药评价与分析》2025年第1期98-101,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：新疆维吾尔自治区药品临床综合评价资助项目(No.XJWJYZ202409)。

摘　　要：目的:探讨维吾尔药百癣夏塔热片上市后及真实世界临床使用的安全性,为百癣夏塔热片临床安全应用提供参考。方法:检索国内外数据库中建库至2024年3月百癣夏塔热片相关药品不良反应(ADR)信息并进行分析;基于医学数据检索与应用平台(医渡云),对2018年1月至2024年3月某三级甲等综合医院及各分院使用百癣夏塔热片的病例进行回顾性分析,对ADR发生情况、器官损害情况、严重程度及转归等进行整理分析。结果:共纳入187例百癣夏塔热片相关ADR,45~<75岁患者占比较高(99例,占52.94%);体重指数>18.0~25.0 kg/m2患者占比较高(109例,占58.29%);无药物过敏史患者占比较高(147例,占78.61%)。百癣夏塔热片的ADR以早期反应(用药后30 min至24 h)为主,相对症状较轻。共发现百癣夏塔热相关新发、严重的ADR 20例(占10.70%),包括3例口咽疼痛、8例皮肤干燥、5例失眠和4例眼部流泪,均为现有药品说明书中未报道的ADR,为补充该药的ADR信息提供了参考;未发现严重的ADR;转归大多为治愈或好转。结论:百癣夏塔热片上市后安全性良好,临床用药期间应加强监测,保障患者用药安全。OBJECTIVE:To probe into the safety of Uygur medicine Baixuan Xiatare tablets in post-marketing and real-world clinical application,so as to provide reference for the clinical safe application of Baixuan Xiatare tablets.METHODS:Information on Baixuan Xiatare tablets-related adverse drug reactions(ADR)was searched from domestic and foreign databases from database establishment to Mar.2024.Based on the medical data retrieval and application platform(Yidu Cloud),a retrospective analysis on patients with Baixuan Xiatare tablets in a GradeⅢClass A general hospital and its branches from Jan.2018 to Mar.2024 was performed to collate and analyze the occurrence of ADR,organ damage degree,severity and outcome.RESULTS:A total of 187 Baixuan Xiatare tablets-related ADR were enrolled,with a higher proportion of patients aged from 45 to<75 years(99 cases,52.94%),a higher proportion of patients with body mass index>18.0 to 25.0 kg/m2(109 cases,58.29%),and a higher proportion of patients with no history of drug allergy(147 cases,78.61%).Baixuan Xiatare tablets-related ADR was predominantly early reactions(from 30 min to 24 h after administration),with relatively mild symptoms.A total of 20 cases(10.70%)of new-onset and severe Baixuan Xiatare tablets-related ADR were found,including 3 cases of oropharyngeal pain,8 cases of dry skin,5 cases of insomnia and 4 cases of ocular tearing,all of them were ADR not reported in the drug instructions,which had provide reference to supplement the ADR information of the drug.No severe ADR was found.Most of outcomes were cured or improved.CONCLUSIONS:Baixuan Xiatare tablets have higher safety after marketing,and monitoring should be strengthened during clinical application to ensure medication safety of patients.

关 键 词：百癣夏塔热片 药品不良反应 安全性评价 

分 类 号：R969.3[医药卫生—药理学]