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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
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李 晋 1, 2* ,方壬德 ,宋 娟 ,张永州 ,张 帆 ,赵 群 ,蔡素华 ,张 怡 ,胡海棠 ,邓剑雄 (1.广州和睦家
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医院药剂科,广州 510335;2.广东省药理学会,广州 510080;3.丽珠医药集团股份有限公司,广东 珠海
519000;4.河南大学淮河医院药剂科,河南 开封 475000;5.聊城市人民医院药剂科,山东 聊城 252000;6.淄
博市中心医院药剂科,山东 淄博 255036;7.广州中医药大学金沙洲医院药剂科,广州 510168;8.东莞康华医
院药剂科,广东 东莞 523080)
中图分类号 R975;R969 文献标志码 A 文章编号 1001-0408(2023)11-1379-05
DOI 10.6039/j.issn.1001-0408.2023.11.18
摘 要 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3 926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 3 926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。
关键词 注射用艾普拉唑钠;回顾性研究;巢式病例对照;安全性研究;药品不良反应;药品不良事件
Retrospective multicenter nested case-control safety study of Ilaprazole sodium for injection
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LI Jin ,FANG Rende ,SONG Juan ,ZHANG Yongzhou ,ZHANG Fan ,ZHAO Qun ,CAI Suhua ,ZHANG Yi ,
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HU Haitang ,DENG Jianxiong(1. Dept. of Pharmacy, Guangzhou United Family Hospital, Guangzhou 510335,
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China;2. Guangdong Pharmacological Society, Guangzhou 510080, China;3. Lizhu Pharmaceutical Group Co.,
Ltd., Guangdong Zhuhai 519000, China;4. Dept. of Pharmacy, Huaihe Hospital of Henan University, Henan
Kaifeng 475000, China;5. Dept. of Pharmacy, Liaocheng Municipal People’s Hospital, Shandong Liaocheng
252000, China;6. Dept. of Pharmacy, Zibo Central Hospital, Shandong Zibo 255036, China;7. Dept. of
Pharmacy, Jinshazhou Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510168, China;
8. Dept. of Pharmacy, Dongguan Kanghua Hospital, Guangdong Dongguan 523080, China)
ABSTRACT 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 3 926 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 3 926 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
Δ 基金项目 广 东 省 药 理 学 会 专 项 研 究 基 金(No. GDPHARS-
sodium for injection. CONCLUSIONS The overall safety of
X20210002)
Ilaprazole sodium for injection is relatively high, and the
*第一作者 副主任药师,博士。研究方向:临床药学与药物安全
occurrence of adverse events is more related to it.
性。E-mail:lijin@gdyl.org KEYWORDS
#a 通信作者 高级工程师。研究方向:药物研发与药物警戒。 Ilaprazole sodium for injection; retrospective
E-mail:huhaitang@livzon.com.cn study; nested case-control; safety study; adverse drug
reaction; adverse drug events
#b 通信作者 副主任医师,博士。研究方向:药物警戒与大规模安
全性。E-mail:dengjianxiong@gdyl.org
中国药房 2023年第34卷第11期 China Pharmacy 2023 Vol. 34 No. 11 · 1379 ·