Efficacy and safety of high-dose dexlansoprazole in the treatment of acute upper gastrointestinal ulcer hemorrhage
10.3760/cma.j.cn311367-20240410-00143
- VernacularTitle:高剂量右兰索拉唑治疗急性上消化道溃疡出血的有效性和安全性研究
- Author:
Huiyun ZHU
1
;
Jianping LU
;
Huizhen FAN
;
Dongfeng CHEN
;
Honghui CHEN
;
Zhenyu ZHANG
;
Xing LI
;
Zhili WEN
;
Jianping CHEN
;
Dunju LIU
;
Zhijun LIU
;
Aijun LIAO
;
Mingliang LU
;
Yiqi DU
;
Zhaoshen LI
Author Information
1. 海军军医大学第一附属医院(上海长海医院)消化内科，上海 200433
- Publication Type:Journal Article
- Keywords:
Dexlansoprazole;
High doses;
Peptic ulcer hemorrhage
- From:
Chinese Journal of Digestion
2024;44(12):793-799
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of high-dose injectable dexlansoprazole in the treatment of acute upper gastrointestinal ulcer hemorrhage.Methods:This study was a randomized, double-blind, positive drug parallel controlled, multicenter clinical trial led by the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), with participation from 43 hospitals such as Yichun People′s Hospital, Army Medical Center of PLA (Chongqing Daping Hospital), etc. From August 31, 2019 to May 25, 2020, 346 patients with upper gastrointestinal hemorrhage caused by acute gastric and (or) duodenal ulcer were selected. The subjects were randomly divided into experimental group and control group according to a 2 to 1 stratification scheme using the SAS 9.4 software. The medication regimen for the experimental group was intravenous injection of dexlansoprazole 30 mg/times, once every 12 h, while the medication regimen for the control group was intravenous injection of lansoprazole and dexlansoprazole mimetics, 30 mg/times, once every 12 h; the treatment course was 5 days. The primary efficacy indicator (72 h effective hemostasis rate), the secondary efficacy indicator(clinical hemostasis rate at 24, 48, and 120 h, and the proportion of subjects who underwent endoscopic treatment or surgical procedures again due to hemorrhage within 5 days), and the incidence of adverse reactions were compared between the 2 groups. Binomial distribution normal approximation method was performed to calculate the 95% confidence interval (95% CI) of the difference in hemostasis rate between the experimental group and the control group. Fisher′s exact test was used for statistical analysis. Results:A total of 329 patients (219 cases in the experimental group and 110 cases in the control group) were enrolled. The 72 h effective hemostasis rate (95% CI) of the experimental and control group was 95.9%(210/219, 92.3% to 98.1%) and 93.6%(103/110, 87.3% to 97.4%), respectively, and the difference was not statistically significant ( P>0.05). The difference in the 72-hour effective hemostasis rate(95% CI) between the experimental and the control group was 2.3% (-3.0% to 7.5%). The clinical hemostasis rates at 24, 48, and 120 h of the treatment were 82.2% (176/214), 99.1%(210/212), and 100.0%(210/210) in the experimental group, and 85.2%(92/108), 98.1%(104/106), and 100.0%(105/105) in the control group, respectively, and the differences were not statistically significant (all P>0.05). The proportion of subjects who underwent endoscopic treatment and surgical procedure again within 5 days (95% CI)of the experimental group and control group was 0 (0 to 1.7%) and 1.9% (0.2% to 6.5%), respectively, and the difference was not statistically significant ( P>0.05). The result of safety evaluation showed that the overall incidence of adverse reactions of the experimental group and the control group was 6.4% (14/219) and 11.8% (13/110), respectively, and the difference was not statistically significant ( P>0.05). Conclusion:High dose injectable dexlansoloprazole is an effective and safe treatment for upper gastrointestinal ulcer hemorrhage, and suitable for clinical application.
