443例舒肝宁注射液的药品不良反应/事件文献分析  

Literature Analysis of Adverse Drug Reactions/Events in 443 Cases of Shuganning Injection

作　　者：郭静[1,2] 杨玉晴 李春晓 凌霄[1,3,4] 马静 李学林 GUO Jing;YANG Yuqing;LI Chunxiao;LING Xiao;MA Jing;LI Xuelin(Dept.of Pharmacy,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450003,China;College of Pharmacy,Henan University of Chinese Medicine,Zhengzhou 450046,China;Henan Province Engineering Research Center for Clinical Application,Evaluation and Transformation of Traditional Chinese Medicine/Henan Province Engineering Laboratory for Clinical Evaluation Technology of Chinese Medicine,Zhengzhou 450003,China;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-Constructed by Henan Province&Education Ministry of P.R.China,Henan University of Chinese Medicine,Zhengzhou 450046,China)

机构地区：[1]河南中医药大学第一附属医院药学部,郑州450003 [2]河南中医药大学药学院,郑州450046 [3]河南省中药临床应用、评价与转化工程研究中心/河南省中药临床药学中医药重点实验室,郑州450003 [4]河南中医药大学呼吸疾病中医药防治省部共建协同创新中心,郑州450046

出　　处：《中国医院用药评价与分析》2025年第1期102-106,110,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：河南省科技攻关项目(No.202102310182,No.232102310476);河南省中医药拔尖人才培养项目(No.2022ZYBJ05);河南省中医药科学研究专项课题(No.2022ZY1049)。

摘　　要：目的:探讨舒肝宁注射液致药品不良反应/事件(ADR/ADE)发生的规律与特征,为舒肝宁注射液临床安全应用提供参考。方法:检索舒肝宁注射液上市后至2024年3月中国知网、万方数据库、维普数据库、中国生物医学文献服务系统、the Cochrane Library、PubMed和Web of Science等数据库中舒肝宁注射液相关ADR/ADE的文献报告,采用描述性分析方法进行研究。结果:共纳入89篇符合标准的文献,包括66篇临床研究、20篇个案报道和3篇ADR监测报告。涉及443例ADR/ADE,主要集中在>40~65岁人群(268例,占60.50%);累及9个器官/系统,共980例次,主要为胃肠道损害(328例次,占33.47%)、全身性损害(300例次,占30.61%)、皮肤及其附件损害(250例次,占25.51%)等;临床表现多样,包括恶心、呕吐、寒战、发热和皮疹等。39例患者有详细ADR/ADE发生时间描述,多为用药后30 min内(26例,占66.67%)。有16.93%的患者(75例)溶剂使用不当,10.83%(48例)超药品说明书推荐用量。122例ADR/ADE可进行严重程度分级,多数为轻中度(108例,占88.52%),症状自然缓解或对症治疗后得以缓解,未报告有严重的ADR/ADE发生。122例ADR/ADE记录了详细的处理过程及转归,转归结果多为痊愈或好转。结论:临床应用舒肝宁注射液过程中,仍需强化用药安全监测。建议临床医务人员严格遵循药品说明书合理用药,以确保患者用药安全。OBJECTIVE:To probe into the regularities and characteristics of adverse drug reactions/adverse drug events(ADR/ADE)induced by Shuganning injection,so as to provide reference for the clinical safety application of Shuganning injection.METHODS:By searching the literature reports for ADR/ADE of Shuganning injection in CNKI,Wanfang Data,VIP,SinoMed,the Cochrane Library,PubMed and Web of Science from the marketing of Shuganning injection to Mar.2024,descriptive analysis method was used to study the ADR/ADE of Shuganning injection.RESULTS:A total of 89 articles were enrolled,including 66 clinical studies,20 case reports and 3 ADR monitoring reports.And 443 cases of ADR/ADE were involved,mainly in patients aged from>40 to 65 years(268 cases,60.50%).There were 980 cases involving 9 organs/systems,mainly gastrointestinal damage(328 cases,33.47%),systemic damage(300 cases,30.61%),skin and its appendages damage(250 cases,25.51%).The clinical manifestations of ADR/ADE were diverse,including nausea,vomiting,chills,fever and rash.Thirty-nine patients had a detailed description of the onset time of ADR/ADE,mostly within 30 min of drug administration(26 cases,66.67%).There were 16.93%patients(75 cases)with improper solvent use,10.83%(48 cases)had off-label drug use.Totally 122 cases of ADR/ADE could be graded in severity,most of which were mild to moderate(108 cases,88.52%),symptoms were relieved naturally or after symptomatic treatment,no severe ADR/ADE was reported.In 122 cases of ADR/ADE,the treatment process and outcome were recorded in detail,and most of the outcomes were recovery or improvement.CONCLUSIONS:In the clinical application of Shuganning injection,it is necessary to strengthen the drug safety monitoring.Clinical staff should strictly follow the drug instructions for rational medication in order to ensure the safety of medication for patients.

关 键 词：舒肝宁注射液 文献分析 临床安全性再评价 药品不良反应 药品不良事件 

分 类 号：R969.3[医药卫生—药理学]