Efficacy and safety of anaprazole in the treatment of reflux esophagitis: a multicenter, randomized, double-blinded phase Ⅱ clinical study
10.3760/cma.j.cn311367-20240412-00146
- VernacularTitle:安奈拉唑钠肠溶片治疗反流性食管炎有效性和安全性的多中心、随机双盲Ⅱ期临床研究
- Author:
Huiyun ZHU
1
;
Huizhen FAN
;
Zhongwei PAN
;
Caibin HUANG
;
Hao WU
;
Jigang RUAN
;
Nonghua LYU
;
Zhaoshen LI
;
Yiqi DU
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:
Anaprazole;
Reflux esophagitis;
Endoscopic healing rate;
Reflux;
Heartburn
- From:
Chinese Journal of Digestion
2024;44(9):590-597
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of anaprazole (40 mg and 60 mg) and compared with rabeprazole (20 mg) in the treatment of reflux esophagitis (RE).Methods:This multicenter, randomized, double-blinded, positive drug parallel controlled study was led by the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) and a total of 24 clinical trial institutions nationwide including the First Affiliated Hospital of Nanchang University, Yichun People′s Hospital, Meihekou Central Hospital, the First Affiliated Hospital of Gannan Medical University, and Jinhua Central Hospital, participated in this research. A total of 156 patients with RE (Los Angeles grade A to D) were enrolled and randomly divided into 3 groups, anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group, using a random number table in a ratio of 1∶1∶1. Patients in the above 3 groups were treated with the appropriate trial medication once per day for 4 or 8 weeks. The endoscopic healing rates were evaluated by Blinded Independent Central Review (BICR) and investigators. In addition, the improvement in the severity of individual symptoms (daytime reflux, daytime heartburn, nighttime reflux, nighttime heartburn) and medication safety were also evaluated. The endoscopic healing rates and 95% confidence intervals (95% CI) at week-8 and -4 were calculated by groups, as well as the difference in the healing rates and their 95% CI among groups. The chi-square test was used for statistical analysis. Results:A total of 153 subjects were included in the full analysis set (FAS), 144 in the per-protocol analysis set (PPS) and 151 in the safety set (SS). In the FAS, after 8 weeks of treatment, the endoscopic healing rates of anaprazole 40 mg group, anaprazde 60 mg group and raberazole 20 mg group blindly assessed by BICR were 86.0% (43/50), 86.5% (45/52) and 86.3% (44/51), respectively, and the 95% CI were 76.4% to 95.6%, 77.3% to 95.8% and 76.8% to 95.7%, respectively.The endoscopic healing rates of anaprazole 40 mg group, anaprazde 60 mg group and raberazole 20 mg group blindly evaluated by investigators were 88.0% (44/50), 90.4% (47/52) and 86.3% (44/51), respectively, and the 95% CI were 79.0% to 97.0%, 82.4% to 98.4% and 76.8% to 95.7%, respectively. The endoscopic healing rates were similar among groups. In the FAS, the differences in healing rates(95% CI) assessed by BICR and investigators between anaprazole 40 mg, anaprazole 60 mg and rabeprazole 20 mg group were -0.3%(-13.7% to 13.2%), 0.6%(-12.3% to 13.6%), respectively and 1.7%(-11.3% to 14.8%), 3.9%(-8.5% to 16.3%), respectively. The results of the PPS were consistent with those of the FAS. After 8 weeks of treatment, the severity scores of individual symptoms (daytime reflux, daytime heartburn, nighttime reflux, nighttime heartburn) decreased in all groups. The differences between post-treatment and baseline in anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group were -1.54±1.00, -1.91±1.00, -1.51±0.76, -1.45±0.71; -1.30±0.94, -1.59±0.96, -1.33±0.65, -1.42±0.60; and -1.74±0.85, -1.76±0.93, -1.45±0.66, -1.66±0.79, respectively. The incidence of treatment emergent adverse event of anaprazole 40 mg group, anaprazole 60 mg group and rabeprazole 20 mg group were 57.1% (28/49), 48.1% (25/52) and 60.0% (30/50), respectively, and the incidence of treatment related adverse event were 18.4% (9/24), 25.0% (13/52) and 24.0% (12/50), respectively. There were no statistically significant differences in the incidence of treatment emergent adverse event and treatment related adverse event among 3 groups (all P>0.05). Conclusion:The efficacy and safety of anaprazole 40, 60 mg/d, and rabeprazole 20 mg/d in the treatment of RE are comparable.
