2016-2020年北京地区799例碘海醇致药品不良反应报告分析

Reports of 799 Cases of Adverse Drug Reactions Induced by Iohexol in Beijing from 2016 to 2020

目的:了解碘海醇的药品不良反应(ADR)发生特点,提示临床用药可能存在的安全性风险,为临床合理应用碘海醇提供依据。方法:对2016-2020年国家ADR监测系统中北京地区收集到的碘海醇所致ADR报告进行回顾性分析。结果:共纳入799例碘海醇致ADR报告,其中严重的ADR 29例,一般的ADR 770例;男性患者395例(占49.44%),女性患者402例(占50.31%),2例性别不详,患者性别占比均衡;>50~70岁年龄段患者最多(442例);ADR的临床表现以皮肤及其附件损害、全身整体损害和胃肠道损害多见。结论:碘海醇引起的一般的ADR通常可以耐受,虽然非离子型碘对比剂的ADR较离子型碘对比剂少,但仍存在严重过敏、休克、迷走神经反应、心脏并发症和栓塞的风险,用药前应仔细评估用药风险,检查前后需对患者进行水化,检查中及检查后需严密观察患者是否出现不适症状。鼓励报告ADR并及时更新循证证据,将新的ADR修订至药品说明书中,以降低患者的用药风险、更好地促进碘海醇的临床合理应用。

OBJECTIVE: To investigate the characteristics of adverse drug reactions(ADR) induced by iohexol, to indicate the possible safety risks of clinical medication, so as to provide basis for rational clinical application of iohexol. METHODS: Retrospective analysis was performed on the ADR reports induced by iohexol collected from the National Center for ADR Monitoring System in Beijing from 2016 to 2020. RESULTS: A total of 799 cases of ADR induced by iohexol were collected, including 29 cases of severe ADR and 770 cases of general ADR. There were 395 male patients(49.44%), 402 female patients(50.31%), and 2 patients with unknown gender, indicating a balanced gender ratio. Patients aged >50 to 70 years were the most(442 cases). The clinical manifestations of ADR were skin and its accessory lesions, systemic lesions and gastrointestinal lesions. CONCLUSIONS: The general ADR induced by iohexol are generally tolerated. Although the ADR of non-ionic iodine contrast agent are less than that of ionic iodine contrast agent, there are still risks of severe allergy, shock, vagus reaction, cardiac complications and embolism. The risks of medication should be carefully evaluated before and after medication, and hydration should be performed on patients before and after examination. During and after the examination, patients should be closely observed for any symptoms of discomfort. It is encouraged to report ADR and update evidence-based evidence in a timely manner, and revise the new ADR into drug instructions to reduce the risk of medication for patients and better promote the rational clinical application of iohexol.