中国医院用药评价与分析2025，Vol.25Issue(3)：362-367,6.DOI:10.14009/j.issn.1672-2124.2025.03.023
基于文献综述的肾康注射液上市后药品不良反应/事件研究
Research on Post-Marketing Adverse Drug Reactions/Events of Shenkang Injection Based on Literature Review
摘要
Abstract
OBJECTIVE:To probe into the occurrence and clinical characteristics of adverse drug reactions/events(ADR/ADE)related to Shenkang injection,and to provide references for clinical safe medication.METHODS:Literature reports of ADR/ADE related to Shenkang injection recorded in PubMed,the Cochrane Library,Embase,Web of Science,CBM,Wanfang Data,VIP and CNKI were retrieved(from the launch of Shenkang injection to Dec.2023)and descriptively analyzed.RESULTS:A total of 127 studies that met the criteria were enrolled,including 106 clinical researches,20 case reports and 1 ADR monitoring,involving a total of 488 cases of ADR/ADE,which were mainly concentrated in patients from 45 to<60 years old(254 cases,52.05%).A total of 526 cases of clinical manifestations of ADR/ADE were collected,involving 12 organs/systems,including gastrointestinal tract(158 cases,30.04%),skin and its accessories(83 cases,15.78%),central and peripheral nervous system(82 cases,15.59%).The main clinical manifestations were nausea and vomiting,diarrhea,rash,itching,dizziness and headache.There were 23 cases reported the occurrence time of ADR/ADE,mostly were≤30 min(18 cases,78.26%).There was no overdose in ADR/ADE patients,but 37.50%of patients(183 cases)had insufficient dose.Infusion speed was reported in 142 patients,of which 11.27%(16 cases)developed ADR/ADE due to excessive infusion speed.A total of 52 cases of ADR/ADE had detailed description of management as well as outcome and prognosis,of which only 8 cases(15.38%)manifested by severe ADR/ADE such as dyspnea,unconsciousness and convulsion.There were no serious ADR/ADE,the outcomes and prognoses of ADR/ADE were all cured or improved in the recorded cases.CONCLUSIONS:Shenkang injection has higher safety,descriptive literature study can obtain more comprehensive and systematic clinical safety information on ADR/ADE of Shenkang injection,which can help clinics rationalize and standardize the application of Shenkang injection,enhance the awareness of drug safety in the clinic,and ensure medication safety.关键词
肾康注射液/药品不良反应/药品不良事件/文献综述Key words
Shenkang injection/Adverse drug reaction/Adverse drug event/Literature review分类
医药卫生引用本文复制引用
杨玉晴,李春晓,李学林,凌霄,杨亚蕾,马静..基于文献综述的肾康注射液上市后药品不良反应/事件研究[J].中国医院用药评价与分析,2025,25(3):362-367,6.基金项目
河南省科技攻关项目(No.232102310476) （No.232102310476）
河南省中医药拔尖人才培养项目(No.2022ZYBJ05) （No.2022ZYBJ05）
河南省中医药科学研究专项课题(No.2022ZY1049) （No.2022ZY1049）
