研究疾病:
|
Barrett 食管
|
研究疾病代码:
|
|
Target disease:
|
Barrett's esophagus
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
治疗新技术临床试验
New Treatment Measure Clinical Study
|
研究目的:
|
1.通过平行、随机、双盲、单模拟临床试验,以患者临床症状疗效判定、食管下段组织病理活检作为疗效判定指标,客观评价降逆消瘅方联合艾司奥美拉唑对CLE-BE的临床疗效;
2.通过临床预实验,收集非BE对照者、治疗组及对照组患者服药前后的食管病灶病变组织进行高通量全转录组mRNA测序,结合生物信息学分析,筛选降逆消瘅方治疗CLE-BE 患者的关键靶点,初探该方截断扭转BE 癌变进程的疗效机制。
基于以上2个研究目的,本研究分为研究一:降逆消瘅方治疗肝胃不和型BE的临床研究,研究二:基于转录组学探讨降逆消瘅方治疗肝胃不和型BE的机制研究。
|
Objectives of Study:
|
1. Through parallel, randomized, double-blind, single-simulation clinical trials, the clinical efficacy of Jiangni Xiaodan formula combined with esomeprazole on CLE-BE was objectively evaluated by using patients' clinical symptom efficacy determination and histopathological biopsy of the lower esophagus as the efficacy determination index;
2. Through clinical pre-testing, high-throughput whole transcriptome mRNA sequencing was performed on the lesions of esophageal foci before and after the administration of the drug in the non-BE control, treatment and control groups, and combined with bioinformatics analysis, to screen the key targets of the Jiangni Xiaodan formula in the treatment of patients with CLE-BE, and to explore the mechanism of the formula's efficacy in reversing the cancerous progression of BE.
Based on the above two research objectives, this study was divided into Study 1: Clinical study of Jiangni Xiaodan formula for the treatment of CLE-BE, and Study 2: Mechanism study of Jiangni Xiaodan formula for the treatment of CLE-BE based on transcriptomics.
|
药物成份或治疗方案详述:
|
治疗分组
1.治疗组:降逆消瘅方颗粒+艾司奥美拉唑镁肠胶囊
降逆消瘅方颗粒:由旋覆梗12g、代赭石15g、黄连3g、吴茱萸3 g、姜半夏9g、柴胡9g、延胡索9g、焦山栀9g、冬凌草15g、石见穿15g组成。中药方采用颗粒制剂,由上海万仕诚药业有限公司生产提供。早晚各1次,每次1包,温开水冲至200ml,餐后半小时到一小时温服,连服12周。
艾司奥美拉唑镁肠溶胶囊(艾速平)(正大天晴药业集团股份有限公司),规格20mg*1粒,早晚各1次,每次2粒,餐前半小时口服,连服12周。
2.对照组:降逆消瘅方颗粒安慰剂+艾司奥美拉唑镁肠溶胶囊
降逆消瘅方颗粒安慰剂由上海万仕诚药业有限公司生产提供,含有10%的试验组治疗药物,结合3%食用焦糖色素(均以总固体量计)、0.04%食用日落黄色素、0.35%食用柠檬黄色素、0.04%糖八乙酸酯以及0.04%麦芽糊精,加水溶解之后喷雾得到喷干粉末,然后制成颗粒,在外观、颜色、气味、包装、使用等方面与试验组一致。使用时开水冲服,配成溶液。该组模拟剂及艾司奥美拉唑镁肠溶胶囊服用方法同试验组。
|
Description for medicine or protocol of treatment in detail:
|
|
纳入标准:
|
1.BE受试者:①符合BE的诊断标准者;②在本研究前停用抑酸制剂如PPI制剂和H2受体拮抗剂、非淄体类抗炎药、抑制素、UDCA等药物超过四周者;③年龄≥18周岁且≤70周岁,性别不限;④签署知情同意书。
2.非BE对照受试者:①肝肾功能、血尿便常规、心电图检查、胃镜检查结果在正常范围内,无反流性食管炎、BE、非糜烂性胃食管反流病等食管疾病,既往无其他功能性或器质性疾病;②不需要常规定期服用药物,且无滥用药物史;③年龄≥18周岁且≤70周岁,性别不限;④签署知情同意书。
|
Inclusion criteria
|
1. BE subjects: ① Meet the diagnostic criteria of BE; ② Discontinue the use of acid-suppressing agents such as PPI agents and H2 receptor antagonists, non-zithromycin anti-inflammatory drugs, inhibitors and UDCA for more than four weeks prior to the study; ③ Age ≥18 and ≤70 years old, gender is not limited; ④ Signed the informed consent form.
2. Non-BE control subjects: ① liver and kidney function, blood, urine and stool routine, electrocardiography, gastroscopy results within the normal range, no reflux esophagitis, BE, non-erosive gastroesophageal reflux disease and other esophageal diseases, and there is no other functional or organic diseases; ② do not need to take drugs on a regular basis, and there is no history of drug abuse; ③ age ≥ 18 years old and ≤ 70 years old, gender is not limited; ④ signed informed consent. consent form.
|
排除标准:
|
1.BE受试者:①有BE病史且经组织学证实为低度不典型增生、高度不典型增生或腺癌者;②胃或食管手术史(含既往接受过BE内镜治疗者);③合并有消化性溃疡、上消化道恶性病变、胃食管和十二指肠手术史、药物性食管炎者、Zollinger-Ellison征者;④妊娠妇女或哺乳期妇女;⑤精神疾病患者及其他无法自我描述症状、理解障碍的患者。
2.非BE对照受试者:①合并有心、脑、肝、肾、泌尿、消化、生殖系统等严重疾病;②妊娠妇女或哺乳期妇女;③精神疾病患者及其他无法自我描述症状、理解障碍的患者;④正在参加其他临床试验者。
|
Exclusion criteria:
|
1. BE subjects: ① those with a history of BE and histologically confirmed low-grade atypical hyperplasia, high-grade atypical hyperplasia or adenocarcinoma; ② those with a history of gastric or esophageal surgery (including those who have previously undergone endoscopic treatment for BE); ③ those with a combination of peptic ulcers, malignant lesions of the upper gastrointestinal tract, history of gastroesophageal and duodenal surgeries, drug-induced esophagitis, and the Zollinger-Ellison sign; ④ those with pregnancy or lactation; ⑤ those with mental illness and other patients who are unable to describe their symptoms or understand their symptoms. Pregnant women or breastfeeding women; ⑤ Patients with mental illness and other patients who are unable to self-describe their symptoms or have comprehension disorders.
2. Non-BE control subjects: ① Combined heart, brain, liver, kidney, urinary, gastrointestinal, reproductive system and other serious diseases; ② pregnant or lactating women; ③ mental illness and other patients who can not self-describe the symptoms, understanding of the obstacles; ④ is participating in other clinical trials.
|
研究实施时间:
Study execute time:
|
从From
2024-09-01
至To
2025-12-31
|
征募观察对象时间:
Recruiting time:
|
从From
2024-09-01
至To
2025-12-31
|