注射用艾普拉唑钠的回顾性多中心巢式病例对照安全性研究

Retrospective multicenter nested case-control safety study of Ilaprazole sodium for injection

目的了解注射用艾普拉唑钠在临床实际应用中的安全性。方法通过中国医院药物警戒系统收集5家三级医院2019年1月1日至2020年2月29日使用注射用艾普拉唑钠的住院患者共3926例的病历资料,采用回顾性多中心单队列研究对注射用艾普拉唑钠进行上市后安全性分析;同时采用巢式病例对照研究(试验组与对照组按1∶4比例匹配)来证实本研究队列基线的稳定性,以及不良反应与注射用艾普拉唑钠的相关性。结果3926例患者中,3例患者使用注射用艾普拉唑钠后共发生了5次不良事件,不良事件发生率为0.076%,无严重不良事件,发生时间均为用药2 d后;不良事件以肝功能指标(丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素)升高为主,均为轻度且未处理,所有不良事件转归均为好转。巢式病例对照研究结果显示,试验组与对照组属于同一背景基线,不良事件的发生与注射用艾普拉唑钠相关性更大。结论注射用艾普拉唑钠整体安全性较高,不良事件的发生与其相关性更大。

OBJECTIVE To understand the safety of Ilaprazole sodium for injection in clinical practice.METHODS From Jan.1st 2019 to Feb.29th 2020,the data of 3926 valid hospitalized patients receiving Ilaprazole sodium for injection were collected prospectively from 5 third-level hospitals through CHPS,and the post-marketing safety analysis was performed by using retrospective multicenter single cohort study.At the same time,a nested case-control study(the ratio of trial group and control group was 1∶4)was used to confirm the baseline stability of this study cohort and the correlation between adverse reactions and Ilaprazole sodium for injection.RESULTS Among 3926 patients,3 patients experienced 5 adverse drug events after using Ilaprazole sodium for injection,with the incidence of 0.076%.There was no serious adverse event,and the occurrence time was 2 days after medication;adverse drug events mainly include elevated liver function indicators(alanine transaminase,aspartate transaminase,total bilirubin),which were mild and untreated,and all adverse drug events were improved.The results of the nested case-control study showed that the trial group and the control group belonged to the same background baseline,and the occurrence of adverse drug events was more closely related to Ilaprazole sodium for injection.CONCLUSIONS The overall safety of Ilaprazole sodium for injection is relatively high,and the occurrence of adverse events is more related to it.