文章摘要
胡泊,刘慧茹,曹靓,毛俊,廖振东,周珂,李帆,金涌,孟祥云.141例碘克沙醇不良反应报告分析[J].中国药事,2022,36(2):209-216
141例碘克沙醇不良反应报告分析
Analysis of 141 Cases of Adverse Drug Reactions Induced by Iodixanol
  
DOI:10.16153/j.1002-7777.2022.02.014
中文关键词: 碘克沙醇  不良反应  防范措施  年龄  用药安全性
英文关键词: iodixanol  adverse reactions  preventive measures  age  medication safety
基金项目:安徽省自然科学基金项目(编号 1808085MH284);合肥市医学重点学科建设资助项目[编号合卫科教(2019)160]
作者单位
胡泊 合肥市第二人民医院药学部,合肥 230026 
刘慧茹 合肥市第二人民医院药学部,合肥 230026 
曹靓 合肥市第二人民医院药学部,合肥 230026 
毛俊 合肥市第二人民医院药学部,合肥 230026 
廖振东 合肥市第二人民医院药学部,合肥 230026 
周珂 合肥市第二人民医院药学部,合肥 230026 
李帆 合肥市第二人民医院药学部,合肥 230026 
金涌 安徽医科大学药学院抗炎免疫药物教育部重点实验室,合肥 230032 
孟祥云 合肥市第二人民医院药学部,合肥 230026 
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中文摘要:
      目的:分析碘克沙醇注射液使用过程中出现的药品不良反应(Adverse Drug Reaction,ADR) 的影响因素,为临床更安全有效使用该类药物提供参考。方法:收集2019年1月-2021年6月合肥市第二人民医院使用碘克沙醇注射液的患者信息,筛选出其中发生ADR的141例患者。收集患者的人口学资料和一般临床资料,包括年龄、性别、体重、给药途径、给药剂量、生产厂家、不良反应特征和结局等。使用单因素分析,分析可能产生ADR的原因。使用单因素和多因素Logistic回归分析,分析不同厂家生产的碘克沙醇ADR发生率的不同。结果:在23282例使用碘克沙醇的患者中,共有141例发生ADR,ADR总发生率为0.61%。单因素分析结果提示,不同性别、不同年龄(<70岁和≥70岁)、 不同厂家和不同给药途径的患者ADR发生率存在统计学差异(P <0.05)。此外,A公司的ADR发生率最高(0.81%),通过单因素和多因素结果表明,性别可能是造成不同厂家生产的碘克沙醇ADR发生率不同的主要原因。ADR发生总体以轻度(79.43%)、急性(85.82%)为主。累及系统-器官153 次,以皮肤及其附件(91.50%)为主。结论:医护人员应对碘克沙醇相关的ADR提高警惕,做好防范措施,提高用药安全性。
英文摘要:
      Objective: To analyze the influencing factors of adverse drug reactions (ADR) during the use of iodixanol injection in order to provide references for safer and effective use of this kind of drug in clinics. Methods: Patients who have used iodixanol injections in Hefei No.2 People's Hospital from January, 2019 to June, 2021 were enrolled in this study, and 141 patients with ADR were selected. The demographic and general clinical data of these patients had been collected, including age, gender, weight, route of administration, dosage, manufacturers, adverse reaction characteristics and outcomes. Univariate analysis was used to analyze the possible causes of ADR. Univariate analysis and multivariate logistic regression analysis were applied to analyze the different incidences of ADR of iodixanols produced by different manufacturers. Results: Among 23282 patients using iodixanols, 141 cases developed ADR, and the total incidence of ADR was 0.61%. Univariate analysis showed that there were significant differences in the incidence of ADR among patients of different genders, ages(<70 years old and ≥70 years old), manufacturers and routes of administration (P < 0.05). In addition, the incidence of ADR of iodixanols produced by A Company was the highest (0.81%). The univariate analysis and multivariate analysis indicated that gender may be the main reason for the different incidences of ADR of iodixanols produced by different manufacturers. Most of the incidences were mild ADRs (79.43%) or acute ADRs (85.82%). System-organs happened 153 times, mainly involving skin and its accessories (91.50%). Conclusion: Medical staff should be vigilant about ADR related to iodixanol and take preventive measures to ensure the safety of medication.
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