目的 分析静脉用铁剂不良反应（ADR）的相关数据和报告质量，为临床静脉用铁剂的合理使用提供参考。方法 收集整理2015年1月—2019年12月江苏省药物不良反应监测中心收集到的284例静脉用铁剂ADR报告，对患者的一般情况、累及器官–系统及临床表现、合并用药、ADR转归、报表质量等进行统计分析。结果 共有10例疑为右旋糖酐铁注射液和274例疑为蔗糖铁注射液引起的ADR报告纳入分析。右旋糖酐铁注射液引起的ADR以全身性损害为主，蔗糖铁注射液引起的ADR以皮肤及其附件损害为主；284例ADR中有13例溶媒用量不适宜，有4例联合用药不适宜；报告平均分为78.95，分值<60分为7份（2.46%）；分值>90分为32份（11.27%），其余245份（86.27%）分值为60～90分。主要影响其报告质量的原因有用药情况、ADR发生过程描述不全或缺失，以及用药原因与原患疾病混淆，药品不良反应分析与关联性评价结果不准确等。结论 静脉用铁剂的不良反应报告中暴露了不合理用药问题，安全、有效、合理的使用药物仍是临床当务之急。同时静脉用药不良反应报告表在规范性和完整性方面的填报质量仍有待提高。

Objective To analyze the data and report quality of ADR of intravenous iron, and to provide reference for rational use of intravenous iron. Methods A total of 284 ADR reports of intravenous iron were collected by Jiangsu Adverse Drug Reaction Monitoring Center from January 2015 to December 2019, and statistical analysis was conducted on the general situation, organ–system involvement and clinical manifestations, drug combination, ADR outcomes and report quality of the patients. Results A total of 10 ADR cases suspected to be caused by iron dextran injection and 274 ADR cases suspected to be caused by iron sucrose injection were included in the analysis. The ADR caused by iron dextran injection was mainly systemic, while the ADR caused by iron sucrose injection was mainly skin and its accessories. Among 284 ADR cases, 13 cases were not suitable for solvent dosage, and 4 cases were not suitable for combination administration. The average score of the reports was 78.95, and the score<60 was divided into 7 reports (2.46%); > 90 was divided into 32 (11.27%), and the remaining 245 (86.27%) with scores ranging from 60 to 90. The main reasons affecting the quality of the reports were medication situation, incomplete or missing description of ADR occurrence process, confusion of medication reasons with the original disease, and inaccurate results of ADR analysis and correlation evaluation. Conclusion There are many problems of irrational drug use in the reports of adverse reactions of intravenous iron. Safe, effective and rational drug use is still a clinical urgent matter. At the same time, the quality of the reporting form of intravenous adverse drug use needs to be improved in terms of standardization and completeness.

R973