Retrospective multicenter nested case-control safety study of Ilaprazole sodium for injection
- VernacularTitle: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
- Author:
Jin LI
1
,
2
;
Rende FANG
2
;
Juan SONG
3
;
Yongzhou ZHANG
4
;
Fan ZHANG
5
;
Qun ZHAO
6
;
Suhua CAI
7
;
Yi ZHANG
8
;
Haitang HU
3
;
Jianxiong DENG
2
Author Information
1. Dept. of Pharmacy，Guangzhou United Family Hospital，Guangzhou 510335，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
- Publication Type:Journal Article
- Keywords:
Ilaprazole sodium for injection;
retrospective
- From:
China Pharmacy
2023;34(11):1379-1383
- CountryChina
- Language:Chinese
-
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 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.
