摘要
目的本研究旨在系统分析集采中选品种碘克沙醇的药物不良反应(Adverse drug reaction,ADR)发生特点及潜在危险因素,为临床优化用药方案、保障患者用药安全提供循证参考。方法采用回顾性研究设计,数据来源于2021年11月—2025年8月福建地区(以福州地区为核心)上报至国家药品不良反应监测系统与福建省某大型三甲医院信息系统的注射用碘克沙醇ADR病例报告。收集患者基本信息(性别、年龄)、用药细节(剂量、生产厂家)、ADR临床表现及转归等数据,通过统计学方法进行描述性分析与关联性探讨。结果本研究共纳入229例集采碘克沙醇致ADR病例,患者男女比例为1.39∶1;年龄分布集中于(58.48±13.97)岁,其中≥55岁患者占比达62.01%。用药剂量方面,≥60 mL者占76.42%。ADR临床表现以皮肤及附件损害最为突出(79.32%),主要包括皮疹、瘙痒等;严重程度以1~2级轻度反应为主,占比超80%;患者总体转归良好,86.46%的病例经处理后恢复正常。结论碘克沙醇临床应用中,皮肤及附件损害是最常见ADR类型,年龄≥55岁、用药剂量≥60 mL或为ADR发生的潜在危险因素。临床医务人员在用药前应全面评估患者风险,用药中加强监测,一旦发生ADR需及时分级处理,以最大程度降低用药风险。
OBJECTIVE To systematically characterize the adverse drug reactions(ADR)of the centralizedprocurement iodixanol and identify potential risk factors,so as to provide evidence-based guidance for optimizing clinical use and safeguarding patient safety.METHODS A retrospective design was used.ADR case reports on Iodixanol injection submitted between November 2021 and August 2025 from Fujian province(Fuzhou as the core area)to the national ADR monitoring system and to the information system of a major tertiary hospital in Fujian were extracted.Patient demographics(sex,age),drug-use details(dose,manufacturer),ADR manifestations,and outcomes were extracted.Descriptive statistics and exploratory associations were applied.RESULTS Of 229 eligible cases,the male-to-female ratio was 1.39∶1;mean age was(58.48±13.97)years,with 62.01%aged≥55 years.A single dose≥60 mL was recorded in 76.42%of cases.Skin and appendage disorders predominated(79.32%),chiefly rash and pruritus.Over 80%of reactions were grade 1-2 mild events.Recovery was favourable:86.46% of patients returned to baseline after management.CONCLUSION Skin and appendage injury is the most frequent ADR of iodixanol.Age≥55 years and a dose≥60 mL may represent independent risk factors.Clinicians should comprehensively evaluate individual risk before administration,intensify surveillance during use,and promptly grade-manage any emerging ADR to minimize patient harm.
作者
徐雪
陈深
XU Xue;CHEN Shen(Department of Radiology,Fujian Medical University Union Hospital,Fuzhou 350001,China;Fuzhou Market Supervision and Monitoring Service Center,Fuzhou 350014,China)
出处
《海峡药学》
2025年第12期126-129,共4页
Strait Pharmaceutical Journal
关键词
碘克沙醇
药品集中带量采购
药物不良反应
危险因素
用药安全
不良反应处置
Iodixanol
Volume-based procurement
Adverse drug reactions
Risk factors
Medication safety
Management of adverse reactions
