研究疾病:
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结直肠腺瘤
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研究疾病代码:
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Target disease:
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Colorectal adenoma
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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1、探讨中医理论与结直肠腺瘤疾病发展及复发之间的关联性:本研究的首要目的是探讨中医脾虚湿瘀理论在结直肠腺瘤疾病发展过程中的临床诊疗认识,基于“脾虚湿瘀”这一病机,从“健脾祛湿化瘀”治则指导下开展运用加味参苓白术散干预结直肠腺瘤术后患者,验证中医脾虚湿瘀理论在该病的认识是否有效准确。
2、验证分析加味参苓白术散在结直肠腺瘤术后患者中的干预效果:本研究通过应用加味参苓白术散的干预,探究评估其对结直肠腺瘤术后患者复发情况的影响,探究其对结直肠腺瘤从炎腺转化角度的影响,对结直肠腺瘤患者肠道菌群的影响,并构建三者的临床相关性。
3、探讨相关血清学指标在结直肠腺瘤炎腺转化中的特征及影响:白介素IL-6、IL-8,肿瘤坏死因子TNF-α,在结直肠腺瘤及结直肠癌发展中具有水平变化趋势,进一步探讨二者在结直肠腺瘤炎腺转化的特征及影响。
4、研究结直肠腺瘤肠道菌群生物学特征:通过应用16SrRNA高通量测序的方法,对结直肠腺瘤患者的肠道菌群进行特征分析研究,通过观察肠道菌群丰度、多样性等角度,探究该特征影响是否与结直肠腺瘤复发、炎腺转化等相关。
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Objectives of Study:
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1. Explore the correlation between traditional Chinese medicine theory and the development and recurrence of colorectal adenoma disease: The primary purpose of this study is to investigate the clinical diagnosis and treatment awareness of traditional Chinese medicine theory of spleen deficiency, dampness and blood stasis in the development process of colorectal adenoma disease. Based on the pathogenesis of "spleen deficiency, dampness and blood stasis," the intervention of modified Shen Ling Bai Zhu San is carried out under the guidance of the treatment principle of "invigorating the spleen, eliminating dampness, and resolving stasis" to intervene in postoperative patients with colorectal adenoma, in order to verify whether the understanding of traditional Chinese medicine theory of spleen deficiency, dampness and blood stasis is effective and accurate in this disease.
2. Verify and analyze the intervention effect of modified Shen Ling Bai Zhu San in postoperative patients with colorectal adenoma: This study evaluates the intervention effect of modified Shen Ling Bai Zhu San on the recurrence of postoperative patients with colorectal adenoma, explores its impact on the transformation of colorectal adenoma from inflammatory gland perspective, its impact on the intestinal flora of colorectal adenoma patients, and constructs the clinical relevance among the three.
3. Investigate the characteristics and effects of relevant serological indicators in the transformation of colorectal adenoma to adenocarcinoma: Interleukin IL-6, IL-8, and Tumor Necrosis Factor TNF-α exhibit changes in levels during the development of colorectal adenoma and colorectal cancer. Further exploration is needed to investigate the characteristics and effects of these indicators in the transformation of colorectal adenoma to adenocarcinoma.
4. Study the biological characteristics of the intestinal microbiota in colorectal adenomas: By applying high-throughput sequencing of 16S rRNA, the characteristics of the intestinal microbiota in patients with colorectal adenomas are analyzed. Through observations of the abundance and diversity of the intestinal microbiota, this study aims to investigate whether these characteristics are related to colorectal adenoma recurrence, inflammation transformation, and other factors.
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药物成份或治疗方案详述:
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予“加味参苓白术散”,处方由贵州省中医院消化内科周素芳专家提供,由贵州省中医院中药房提供,具体药物组成:白扁豆20g、党参15g、麸炒白术20g、茯苓15g、炙甘草6g、山药30g、莲子10g、桔梗10g、薏苡仁30g、砂仁6g、白花蛇舌草20g、半枝莲15g、玄参10g;予水煎服,每天三次,每次约150ml,治疗周期为3个月,术后1年复查肠镜。
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Description for medicine or protocol of treatment in detail:
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The prescription of "Jiawei Shen Ling Bai Zhu San" was provided by expert Zhou Sufang from the Department of Gastroenterology at Guizhou Provincial Hospital of Traditional Chinese Medicine, and provided by the Chinese medicine pharmacy of Guizhou Provincial Hospital of Traditional Chinese Medicine. The specific composition of the medicine includes 20g of white hyacinth bean, 15g of codonopsis, 20g of fried white atractylodes, 15g of poria, 6g of licorice, 30g of Chinese yam, 10g of lotus seed, 10g of platycodon root, 30g of coix seed, 6g of amomum, 20g of snake tongue grass, 15g of half-stemmed lotus, and 10g of scutellaria. It is to be decocted in water, taken three times a day, approximately 150ml each time, with a treatment period of 3 months, followed by a colonoscopy reexamination 1 year after surgery.
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纳入标准:
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(1)经肠镜检查发现结直肠息肉并行内镜下息肉切除术,术后符合结直肠腺瘤诊断标准;
(2)符合中医脾虚湿瘀证候诊断标准;
(3)年龄在18-70岁之间,性别不限;
(4)未服用有相关可能预防药物的作用如,阿司匹林、塞来昔布、叶酸片、黄连素等;
(5)患者知情同意并签署同意书;
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Inclusion criteria
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(1) Colorectal polyps found by colonoscopy and endoscopic polypectomy were performed, which met the diagnostic criteria for colorectal adenoma after surgery;
(2) Meet the diagnostic criteria for spleen deficiency and dampness stasis syndrome in traditional Chinese medicine;
(3) Age between 18-70 years old, gender is not limited;
(4) Not taking relevant drugs that may prevent the effects of drugs, such as aspirin, celecoxib, folic acid tablets, berberine, etc.;
(5) Patient informed consent and signed consent form;
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排除标准:
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(1)存在严重并发症,如肠根阻,消化道出血等;
(2)经病理证实发生癌变者
(3)合并有其他如锯齿状息肉、幼年型息肉综合征、家族腺瘤样息肉病等;
(4)患有精神疾患,无法配合临床诊治者;
(5)妊娠期妇女或哺乳期妇女;
(6)合并有其他严重原发性疾病者,如肝肾心肺脏器损害者;
(7)过敏体质或有多种药物过敏史者
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Exclusion criteria:
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(1) There are serious complications, such as intestinal root obstruction, gastrointestinal bleeding, etc.;
(2) Those who have been pathologically confirmed to have cancer
(3) Combined with other such as serrated polyps, juvenile polyposis syndrome, familial adenomatous polyposis, etc.;
(4) Those who suffer from mental disorders and are unable to cooperate with clinical diagnosis and treatment;
(5) Pregnant women or lactating women;
(6) Patients with other serious primary diseases, such as liver, kidney, cardiopulmonary organ damage;
(7) Those with allergies or a history of allergies to multiple drugs
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研究实施时间:
Study execute time:
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从From
2024-01-01
至To
2025-12-31
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征募观察对象时间:
Recruiting time:
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从From
2024-04-01
至To
2025-12-31
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