研究疾病:
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腹泻型肠易激综合征、功能性消化不良
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研究疾病代码:
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Target disease:
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Diarrhea predominant irritable bowel syndrome, functional dyspepsia
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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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本研究拟通过以功能性消化不良患者为载体,通过以胃的合募配穴(合穴足三里、募穴中脘)不同干预方式(针刺和艾灸)下对FD患者产生的不同临床效应和静息态功能磁共振成像(rs-fMRI)下不同功能核团的表现,来探讨FD患者经过合募配穴针刺与艾灸干预的信号在大脑高位中枢的汇聚整合规律,为针灸临床合募配穴理论提供客观依据,丰富合募配穴理论的科学内涵。为FD的中医药综合治疗方案提供验证和高质量临床证据。
本研究拟通过以腹泻型肠易激综合征患者为载体,通过以大肠合募配穴(大肠合穴上巨虚、募穴天枢)不同干预方式(针刺与艾灸)下对IBS-D患者产生的不同临床效应和静息态功能磁共振成像(rs-fMRI)下不同功能核团的表现,来探讨IBS-D患者经过合募配穴针刺、艾灸干预的信号在大脑高位中枢的汇聚整合规律,为针灸临床合募配穴理论提供客观依据,丰富合募配穴理论的科学内涵。为IBS-D的中医药综合治疗方案提供验证和高质量临床证据。
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Objectives of Study:
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This study intends to explore the convergence and integration rule of signals of combined acupoint acupuncture and moxibustion intervention of FD patients in the upper brain center by taking functional dyspepsia patients as the carrier, through different clinical effects on FD patients under different intervention modes (acupuncture and moxibustion) of the stomach (combined acupoint Zusanli, combined acupoint Zhongwan) and different functional nuclei under resting state functional magnetic resonance imaging (rs fMRI), to provide objective basis for the clinical combined acupoint theory of acupuncture and moxibustion and enrich the scientific connotation of the combined acupoint theory. Provide validation and high-quality clinical evidence for the comprehensive treatment plan of traditional Chinese medicine for FD.
This study intends to explore the convergence and integration law of signals of IBS-D patients through combined acupoint acupuncture and moxibustion intervention in the upper brain center by taking the patients with diarrhea predominant irritable bowel syndrome as the carrier, through the different clinical effects on IBS-D patients under different intervention methods (acupuncture and moxibustion) (Shangjuxu of the combined acupoint of large intestine and Tianshu of the raised acupoint) and the performance of different functional nuclei under resting state functional magnetic resonance imaging (rs fMRI), to provide objective basis for the clinical combined acupoint theory of acupuncture and moxibustion and enrich the scientific connotation of the combined acupoint theory. Provide validation and high-quality clinical evidence for the comprehensive treatment plan of traditional Chinese medicine for IBS-D.
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药物成份或治疗方案详述:
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(1)分别观察针刺和艾灸足三里配中脘前后功能性消化不良患者大脑 ALFF.ReHo.
ROI 的变化情况,初步採明胃合募配穴针刺和艾灸所引起脑功能变化的差异性。
(2)观察胃合募配穴针刺、艾灸对功能性消化不良患者血清胃动素、血清胃泌素、血清P物质、胃排空指数、消化不良症状积分、尼平消化不良指数的影响,为进一步丰富中医药综合治疗 FD 诊疗方案提供验证和高质量临床证据;探讨胃合募配穴针刺、艾灸效应与脑功能变化的相关性。
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Description for medicine or protocol of treatment in detail:
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(1) Observe the ALFF in the brain of patients with functional dyspepsia before and after acupuncture and moxibustion at Zusanli and Zhongwan ReHo.
The changes in ROI were preliminarily investigated to determine the differences in brain function changes caused by acupuncture and moxibustion at the Wei He Fu Pei acupoint.
(2) Observing the effects of acupuncture and moxibustion at the Stomach Joint Recruitment Points on serum motilin, serum gastrin, serum substance P, gastric emptying index, dyspepsia symptom score, and Niping dyspepsia index in patients with functional dyspepsia, providing validation and high-quality clinical evidence for further enriching the comprehensive treatment of FD with traditional Chinese medicine; Exploring the correlation between the acupuncture and moxibustion effects of the Stomach Joint Recruitment Points and changes in brain function.
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纳入标准:
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(1)符合罗马Ⅳ中 FD、IBS-D 的诊断标准; (2)年龄 18 岁≤年龄≤65 岁; (3)右利手; (4)大专以上学历; (5)在进入研究前至少15 天内没有服用过任何胃肠促动力药; (6)在进入研究前的 3 个月,未接受针灸治疗; (7)体内无金属植入物,无磁共振扫描禁忌; (8)患者本人签署或由其直系亲属代签知情同意书。 (注:同时具备以上 8 点者,方可纳入研究。)
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Inclusion criteria
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(1) Meets the diagnostic criteria for FD and IBS-D in Rome IV; (2) Age between 18 and 65 years old; (3) Right-handed hand; (4) College degree or above; (5) Have not taken any gastrointestinal prokinetic drugs for at least 15 days prior to entering the study; (6) 3 months before entering the study, he did not receive acupuncture and moxibustion treatment; (7) No metal implants in the body, no contraindications for magnetic resonance imaging scanning; (8) The patient signs or has their immediate family members sign the informed consent form on their behalf. (Note: Only those who meet the above 8 criteria can be included in the study.)
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排除标准:
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(1)有其他功能性消化不良亚型的严重症状,如上腹痛综合征 患者的严重腹痛; (2)意识不清,难以表达主观不适症状者及精神病患者; (3)进展性恶性肿瘤患者或其它严重消耗性疾病患者,易合并 感染及出血者; (4)合并心血管系统、消化系统、造血系统、肝、肾等严重原 发性疾病者; (5)妊娠或哺乳期妇女; (6)伴严重抑郁、焦虑的症状者(7)伴严重痛经的女性患者、伴明显头痛及偏头痛者、有头部 外伤史者; (8)有明确器质性病变或严重头颅解剖结构不对称的患者; (9)有 MRI 禁忌症(如体内有金属植入物,或者有幽闭恐惧 第 4 页 共 25 页 综合征等)。 (注:符合上述任何一点,即予排除。)
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Exclusion criteria:
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(1) Severe symptoms of other functional dyspepsia subtypes, such as severe abdominal pain in patients with upper abdominal pain syndrome; (2) Individuals with unclear consciousness, difficulty expressing subjective discomfort symptoms, and psychiatric patients; (3) Patients with progressive malignant tumors or other serious wasting diseases, who are prone to co infection and bleeding; (4) Patients with severe primary diseases of the cardiovascular system, digestive system, hematopoietic system, liver, kidney, etc; (5) Pregnant or lactating women; (6) Patients with severe symptoms of depression and anxiety (7), female patients with severe dysmenorrhea, those with obvious headaches and migraines, and those with a history of head trauma; (8) Patients with clear organic lesions or severe head anatomical asymmetry; (9) There are contraindications for MRI (such as metal implants in the body, or claustrophobia syndrome, etc.). (Note: If any of the above criteria are met, they are excluded.)
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研究实施时间:
Study execute time:
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从From
2023-10-01
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
2024-06-01
至To
2025-12-31
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