Multicenter,randomized,superiority,parallel-controlled clinical study of compound azinomide enteric-coated tablets in the treatment of dyspepsia after laparoscopic cholecystectomy
10.7659/j.issn.1005-6947.240487
- VernacularTitle:复方阿嗪米特肠溶片治疗腹腔镜胆囊切除术后消化不良的多中心、随机、优效、平行对照临床研究
- Author:
Jialu CHEN
1
;
Yue TANG
;
Delong QIN
;
Zonglong LI
;
Peng GONG
;
Hong ZHU
;
Jianhua LIU
;
Junjing ZHANG
;
Zhimin GENG
;
Yubin ZHANG
;
Xinjian XU
;
Zhaohui TANG
Author Information
1. 上海交通大学医学院附属新华医院 普通外科,上海 200092
- Publication Type:Journal Article
- Keywords:
Cholecystectomy,Laparoscopic;
Dyspepsia;
Compound Azinamide Enteric-Coated Tablet;
Clinical Trial
- From:
Chinese Journal of General Surgery
2025;34(2):298-309
- CountryChina
- Language:Chinese
-
Abstract:
Background and Aims:Laparoscopic cholecystectomy(LC)is a common surgical method for the treatment of gallbladder diseases.However,some patients experience symptoms such as dyspepsia after surgery,which can affect their quality of life.Compound azinomide enteric-coated tablets,a novel drug,may improve dyspeptic symptoms after LC.This study was conducted to explore the clinical efficacy of compound azinomide enteric-coated tablets in treating post-LC dyspepsia symptoms through a multicenter clinical trial.Methods:A multicenter,superior efficacy,open-label,parallel-controlled design was used.Patients with postoperative dyspepsia were enrolled in 7 centers between January 2023 and May 2024.Patients were randomly assigned to either the observation or control groups using a random number table.The observation group received compound azinomide enteric-coated tablets,while the control group was treated with a combination of oryzae pancreatin tablets and ursodeoxycholic acid tablets.Both groups were treated for 4 weeks.The primary endpoints included gastrointestinal symptom scores and quality of life scores assessed before and at 14 and 28 d after treatment.Additionally,the incidence of adverse reactions and cost-effectiveness ratio(CER)were compared between the groups.Results:A total of 303 patients were included,with 150 in the observation group and 153 in the control group.Baseline characteristics were balanced between the groups before treatment(all P>0.05).After treatment,the observation group showed significantly higher effective rates at 14 d and 28 d than the control group(44.7%vs.29.4%;98.0%vs.73.9%,both P<0.05).The observation group also had significantly lower symptom scores and quality of life scores at both 14 and 28 d,with a significantly higher improvement rate in symptom scores compared to the control group(all P<0.05).Further analysis of the improvement rate and treatment efficacy for individual symptoms revealed that,except for the 14-d improvement in abdominal pain/discomfort,the observation group showed better improvement in all other symptoms at 14 d and in all symptoms at 28 d compared to the control group(all P<0.05).No adverse reactions were observed in either group.The CER for the observation group was 283.78 yuan/efficacy rate at 14 d and 128.57 yuan/efficacy rate at 28 d,while the control group's CER was 729.93 yuan/efficacy rate at 14 d and 290.22 yuan/efficacy rate at 28 d.Conclusion:Compound azinomide enteric-coated tablets demonstrated good clinical efficacy in treating dyspepsia symptoms after LC with excellent safety and high cost-effectiveness.Despite some limitations,the results provide a new treatment option for dyspepsia after LC.Larger-scale randomized controlled trials are needed to validate this study's conclusions further.
