目的 分析靜脈用鐵劑不良反應(yīng)（ADR）的相關(guān)數(shù)據(jù)和報(bào)告質(zhì)量，為臨床靜脈用鐵劑的合理使用提供參考。方法 收集整理2015年1月—2019年12月江蘇省藥物不良反應(yīng)監(jiān)測(cè)中心收集到的284例靜脈用鐵劑ADR報(bào)告，對(duì)患者的一般情況、累及器官–系統(tǒng)及臨床表現(xiàn)、合并用藥、ADR轉(zhuǎn)歸、報(bào)表質(zhì)量等進(jìn)行統(tǒng)計(jì)分析。結(jié)果 共有10例疑為右旋糖酐鐵注射液和274例疑為蔗糖鐵注射液引起的ADR報(bào)告納入分析。右旋糖酐鐵注射液引起的ADR以全身性損害為主，蔗糖鐵注射液引起的ADR以皮膚及其附件損害為主；284例ADR中有13例溶媒用量不適宜，有4例聯(lián)合用藥不適宜；報(bào)告平均分為78.95，分值<60分為7份（2.46%）；分值>90分為32份（11.27%），其余245份（86.27%）分值為60～90分。主要影響其報(bào)告質(zhì)量的原因有用藥情況、ADR發(fā)生過(guò)程描述不全或缺失，以及用藥原因與原患疾病混淆，藥品不良反應(yīng)分析與關(guān)聯(lián)性評(píng)價(jià)結(jié)果不準(zhǔn)確等。結(jié)論 靜脈用鐵劑的不良反應(yīng)報(bào)告中暴露了不合理用藥問(wèn)題，安全、有效、合理的使用藥物仍是臨床當(dāng)務(wù)之急。同時(shí)靜脈用藥不良反應(yīng)報(bào)告表在規(guī)范性和完整性方面的填報(bào)質(zhì)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