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  

Multicenter,randomized,superiority,parallel-controlled clinical study of compound azinomide enteric-coated tablets in the treatment of dyspepsia after laparoscopic cholecystectomy

作　　者：陈家璐 唐玥 覃德龙 李宗龙 巩鹏 朱红[3] 刘建华[4] 张俊晶 耿智敏[6] 张玉斌[7] 徐新建 汤朝晖[1] CHEN Jialu;TANG Yue;QIN Delong;LI Zonglong;GONG Peng;ZHU Hong;LIU Jianhua;ZHANG Junjing;GENG Zhimin;ZHANG Yubin;XU Xinjian;TANG Zhaohui(Department of General Surgery,Xinhua Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China;Department of General Surgery,Shenzhen University General Hospital,Shenzhen,Guangdong 518000,China;Department of Hepatobiliary and Pancreatic Surgery,the Second Affiliated Hospital of Kunming Medical University,Kunming 650032,China;Department of Hepatobiliary Surgery,the Second Hospital of Hebei Medical University,Shijiazhuang 050051,China;Department of Hepatobiliary Surgery,Hohhot First Hospital,Hohhot 010000,China;Department of Hepatobiliary Surgery,the First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China;Department of Hepatobiliary Surgery,Shijiazhuang People's Hospital,Shijiazhuang 050000,China;Department of Hepatobiliary Surgery,the Fifth Affiliated Hospital of Xinjiang Medical University,Urumqi 830011,China)

机构地区：[1]上海交通大学医学院附属新华医院普通外科,上海200092 [2]深圳大学总医院普通外科,广东深圳518000 [3]昆明医科大学第二附属医院肝胆胰外科,云南昆明650032 [4]河北医科大学第二医院肝胆外科,河北石家庄050051 [5]内蒙古呼和浩特市第一医院肝胆外科,内蒙古呼和浩特010000 [6]西安交通大学第一附属医院肝胆外科,陕西西安710061 [7]河北省石家庄市人民医院肝胆外科,河北石家庄050000 [8]新疆医科大学第五附属医院肝胆外科,新疆乌鲁木齐830011

出　　处：《中国普通外科杂志》2025年第2期298-309,共12页China Journal of General Surgery

基　　金：国家自然科学基金资助项目(81772521);上海交通大学医学院附属新华医院院级临床研究培育基金资助项目(17CSK06);上海交通大学医学院多中心临床研究基金资助项目(DLY201807)。

摘　　要：背景与目的:腹腔镜胆囊切除术(LC)是治疗胆囊疾病的常见手术方式,但术后部分患者会出现消化不良等症状,影响生活质量。复方阿嗪米特肠溶片作为一种新型药物,可能对LC术后消化不良症状具有改善作用。本研究通过多中心临床试验,探讨复方阿嗪米特肠溶片在LC术后消化不良症状治疗中的临床效果。方法:采用多中心、优效、开放标签、平行对照设计,纳入2023年1月—2024年5月7家中心LC术后消化不良患者,采用随机数字表法将患者分为观察组和对照组。观察组患者实施复方阿嗪米特肠溶片治疗,对照组患者实施米曲菌胰酶片+熊去氧胆酸片联合治疗,两组均治疗4周。比较两组服药前、服药后14 d和28 d评估胃肠症状积分与生活质量评分,以及不良反应发生率和成本效益比(CER)。结果:最终纳入303例患者,其中观察组150例,对照组153例。服药前,两组患者基线特征均衡,差异无统计学意义(均P>0.05)。服药后,观察组14 d和28 d有效率均明显高于对照组(44.7%vs. 29.4%;98.0%vs. 73.9%,均P<0.05);观察组服药后14 d和28 d的症状积分、生活质量评分均明显低于对照组,而症状积分改善率均明显高于对照组(均P<0.05);对各症状积分改善率与治疗有效率单独分析,结果显示,除14 d腹痛/腹部不适外改善情况两组间无明显差异外,观察组14 d其余症状改善情况和28 d所有症状改善情况均优于对照组(均P<0.05)。两组均未发生不良反应事件。观察组14 d和28 d的CER为283.78元/有效率、128.57元/有效率,对照组为729.93元/有效率、290.22元/有效率。结论:复方阿嗪米特肠溶片治疗LC术后消化不良症状有良好的临床效果,同时具有较好的安全性,且体现了较高的成本效益。本研究有一定的局限性,但其结果为LC术后消化不良的治疗提供了新的选择。未来需开展更大规模的随机对照试验,以进一步验证本研究的结论。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 showe

关 键 词：胆囊切除术 腹腔镜 消化不良 复方阿嗪米特肠溶片 临床试验 

分 类 号：R657.4[医药卫生—外科学]