研究疾病:
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慢性结肠炎
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研究疾病代码:
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Target disease:
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chronic colitis
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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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探索性研究/预试验
Pilot clinical trial
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研究目的:
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以慢性结肠炎患者为研究对象,采用随机对照设计,初步评价应用电针刺激敏化部位、电针刺激常规腧穴对慢性结肠炎的治疗效果,以期明确电针刺激敏化部位在慢性结肠炎治疗中的疗效,达到指导临床优化选穴、提高临床疗效的目的。
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Objectives of Study:
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Taking patients with chronic colitis as the research object, a randomized controlled design was used to initially evaluate the therapeutic effect of applying electroacupuncture to stimulate the sensitized site and electroacupuncture to stimulate the conventional acupoints on chronic colitis, with a view to clarifying the therapeutic efficacy of electroacupuncture to stimulate the sensitized site in the treatment of chronic colitis, so as to achieve the purpose of guiding the clinic to optimize the selection of acupoints and to improve the clinical therapeutic efficacy.
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药物成份或治疗方案详述:
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纳入符合慢性结肠炎诊断标准的90例患者为观察对象,采取随机对照的原则,随机分为3组,即干预组、对照1组、对照2组,每组30例。干预组患者在常规治疗的基础上,配合电针治疗,刺激部位为下肢小腿部、上肢前臂部、腹部、及背腰部的敏化部位(共4个);对照1组患者在常规治疗的基础上,配合电针治疗,刺激部位为中脘、天枢、足三里、上巨虚,穴位的选择基于既往针刺治疗慢性结肠炎的文献[1-3];对照2组仅使用常规治疗。3组分别于治疗4周前后以及随访4周后各时点观察症状,肠易激综合征严重程度调查表(IBS-SSS),焦虑抑郁自评量表(SAS、SDS),内脏敏感指数(Visceral Sensitivity Index,VSI),肠镜观察分级等。评价电针敏化部位治疗慢性结肠炎的有效性和安全性。
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Description for medicine or protocol of treatment in detail:
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Ninety patients who met the diagnostic criteria of chronic colitis were included as observation subjects, and the principle of randomized control was adopted, and they were randomly divided into three groups, i.e., the intervention group, the control 1 group, and the control 2 group, with 30 cases in each group. Patients in the intervention group were treated with electroacupuncture on the basis of conventional treatment, and the stimulation sites were the lower limb calves, upper limb forearms, abdomen, and the sensitized sites in the dorsal and lumbar regions (a total of 4); patients in the control 1 group were treated with electroacupuncture on the basis of conventional treatment, and the stimulation sites were the middle epigastric region, the heavenly pivot, the foot Sanli, and the upper Guxu, and the selection of the acupoints was based on the literature of the previous acupuncture treatments for chronic colitis [1-3]; the control 2 group used conventional treatment only. group only used conventional treatment. 3 groups were observed before and after 4 weeks of treatment and at each time point after 4 weeks of follow-up for symptoms, Irritable Bowel Syndrome Severity Questionnaire (IBS-SSS), Self-assessment Scale for Anxiety and Depression (SAS, SDS), Visceral Sensitivity Index (VSI), and enteroscopic observation grading, respectively. To evaluate the efficacy and safety of electroacupuncture sensitized sites for the treatment of chronic colitis.
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纳入标准:
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(1)符合慢性结肠炎诊断标准的患者(即临床表现为反复腹痛、腹泻稀便(或便秘),便中不含或仅有少量血液、黏液,无或有轻度全身症状;肠镜可见局部充血、水肿或散在的红斑、糜烂;结肠粘膜组织病理检查呈慢性炎症性改变)。
(2)性别不限,年龄 18-65 岁之间;
(3)愿意参与试验并签署知情同意书者;
注:同时符合以上3项的患者,方可纳入本项研究。
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Inclusion criteria
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(1) Patients who meet the diagnostic criteria for chronic colitis (i.e., clinical manifestations of recurrent abdominal pain, diarrhea and loose stools (or constipation), with no or only a small amount of blood or mucus in the stools, and no or mild systemic symptoms; local congestion, edema, or scattered erythema and erosions visible by colonoscopy; and chronic inflammatory changes in the histopathological examination of the colonic mucosa).
(2) Sex is not limited, age between 18-65 years old;
(3) Those who are willing to participate in the trial and sign the informed consent;
Note: Patients who meet the above 3 items at the same time can be included in this study.
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排除标准:
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(1)不符合诊断标准及纳入病例标准者;
(2)既往有心肌梗死、严重心力衰竭、瓣膜性心脏病、严重的心律失常原发性心肌病、血液类疾病;以及伴有其他严重脑血管疾病者。
(3)妊娠期、哺乳期妇女、精神类疾病患者无法配合者;
(4)合并肠结核、细菌性菌痢、放射性结肠炎、恶性肿瘤患者;
(5)同时参加其他临床试验者;
(6)针具过敏患者;
(7)近三个月接受针灸治疗者;
注:凡符合上述任何一条,均予以排除。
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Exclusion criteria:
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(1) Those who do not meet the diagnostic criteria and the criteria for inclusion of cases;
(2) Those with previous myocardial infarction, severe heart failure, valvular heart disease, severe arrhythmia primary cardiomyopathy, hematologic diseases; and those with other serious cerebrovascular diseases.
(3) Pregnant and lactating women, and patients with mental diseases who are unable to cooperate;
(4) Patients with combined intestinal tuberculosis, bacterial dysentery, radiation colitis, and malignant tumors;
(5) Those who participate in other clinical trials at the same time;
(6) Patients who are allergic to needles;
(7) Those who have received acupuncture treatment in the last three months;
Note: Anyone who meets any of the above will be excluded.
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研究实施时间:
Study execute time:
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从From
2024-03-21
至To
2025-03-21
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征募观察对象时间:
Recruiting time:
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从From
2024-03-21
至To
2025-03-21
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