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针刺力敏腧穴治疗功能性消化不良的代谢组学研究

注册号：

Registration number：

ITMCTR2025000357

最近更新日期：

Date of Last Refreshed on：

2025-02-19

注册时间：

Date of Registration：

2025-02-19

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

针刺力敏腧穴治疗功能性消化不良的代谢组学研究

Public title：

Metabolomic study on the treatment of functional dyspepsia with acupuncture at acupoints sensitive to force

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺力敏腧穴治疗功能性消化不良的代谢组学研究

Scientific title：

Metabolomic study on the treatment of functional dyspepsia with acupuncture at acupoints sensitive to force

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张格

研究负责人：

李芳

Applicant：

zhangge

Study leader：

Li Fang

申请注册联系人电话：

Applicant telephone：

13879193707

研究负责人电话：

Study leader's telephone：

13879193707

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

1350894322@qq.com

研究负责人电子邮件：

Study leader's E-mail：

15620602@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

江西省南昌市东湖区八一大道445号

研究负责人通讯地址：

江西省南昌市东湖区八一大道445号

Applicant address：

No. 445 East Lake Road Nanchang City Jiangxi Province

Study leader's address：

No. 445 East Lake Road Nanchang City Jiangxi Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

江西中医药大学附属医院

Applicant's institution：

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

JZFYLL202400822105

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

江西中医药大学附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/8/22 0:00:00

伦理委员会联系人：

熊明奕

Contact Name of the ethic committee：

Xiong Mingyi

伦理委员会联系地址：

江西中医药大学附属医院医学伦理委员会

Contact Address of the ethic committee：

Medical Ethics Committee of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

伦理委员会联系人电话：

Contact phone of the ethic committee：

0791-86363831

伦理委员会联系人邮箱：

Contact email of the ethic committee：

853546250@qq.com

研究实施负责（组长）单位：

江西中医药大学附属医院

Primary sponsor：

Jiangxi University of Traditional Chinese Medicine Affiliated Hospital

研究实施负责（组长）单位地址：

江西省南昌市东湖区八一大道445号

Primary sponsor's address：

No. 445 Bayi Avenue Donghu District Nanchang City Jiangxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江西省

市(区县)：

南昌市

Country：

China

Province：

Jiangxi Province

City：

Nanchang city

单位(医院)：

江西中医药大学附属医院

具体地址：

江西省南昌市东湖区八一大道445号

Institution
hospital：

Jiangxi University of Traditional Chinese Medicine Affiliated Hospital

Address：

No. 445 East Lake Road Nanchang City Jiangxi Province

经费或物资来源：

力敏腧穴科技创新团队

Source(s) of funding：

Limin acupoint science and technology innovation team

研究疾病：

功能性消化不良

研究疾病代码：

Target disease：

Functional dyspepsia

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：

其它

Others

研究目的：

功能性消化不良( functional dyspepsia, FD)是以早饱、餐后不适、上腹痛、上腹灼烧感其中一项或多项症状为主要表现，且未见器质性病变的一种功能性胃肠道疾病( functional gastrointestinal disorder, FGID)。据报道统计FD全球发病率达30%，西方达10%-40%，亚洲达5%-30%，女性多于男性。在我国医 疗系统中FD患者占比可达内科门诊数量的10%。目前，西医治疗本病仅仅以对症处理为主，如促进胃肠蠕动，加快胃排空,舒张胃底痉挛,抑制胃酸分泌等,虽能及时改善患者腹胀腹痛等消化不良症状，但停药后易于复发，且长期服用西药易导致肝功能损伤、恶心呕吐、头痛头晕、腹痛腹泻等不良反应的发生,治疗效果有待提高。基于本病病理生理学机制的复杂性，从现代医学的治疗角度出发临床效果有限，依旧存在诸多问题待于解决。因此本实验以FD为研究对象，引入代谢组学，通过对代谢产物定量和定性分析，以期发现FD潜在生物标记物及代谢通路，证实力敏针刺的有效性，为临床治疗FD选穴提供参考依据以及探究针刺力敏腧穴治疗FD的效应机制。

Objectives of Study：

Functional dyspepsia (FD) is a functional gastrointestinal disorder (FGID) characterized by one or more of the symptoms of early satiety postprandial discomfort epigastric pain and epigastric burning and no organic lesions are seen. According to statistics the global incidence of FD is 30% 10%-40% in the West and 5%-30% in Asia with more women than men. In China's medical system FD patients account for up to 10% of the number of internal medicine outpatient clinics. At present the treatment of this disease by Western medicine is only based on symptomatic treatment such as promoting gastrointestinal peristalsis accelerating gastric emptying dilating fundus spasm inhibiting gastric acid secretion etc. although it can improve the symptoms of dyspepsia such as abdominal distension and abdominal pain in patients in time it is easy to recur after stopping the drug and long-term use of Western medicine is easy to lead to liver damage nausea and vomiting headache dizziness abdominal pain and diarrhea and other adverse reactions and the treatment effect needs to be improved. Due to the complexity of the pathophysiological mechanism of this disease the clinical effect is limited from the perspective of modern medical treatment and there are still many problems to be solved. Therefore this study took FD as the research object introduced metabolomics and analyzed metabolites quantitatively and qualitatively in order to discover the potential biomarkers and metabolic pathways of FD prove the effectiveness of force-sensitive acupuncture provide a reference for the clinical treatment of FD and explore the effect mechanism of acupuncture force-sensitive acupuncture in the treatment of FD.

药物成份或治疗方案详述：

四、治疗方案 1.力敏腧穴探查 1.1探查前准备 选择安静、光线充足、室温18-25℃的治疗室内，嘱患者休息10min后取舒适体位，避开其他无关人员后，充分暴露受试者探查部位。 1.2测量仪器 压痛阈值测定采用手持式测痛仪，产品型号：JNT-CTY，北京翼诺泰科技发展有限公司，探头直径1.05mm，量程0～1kgf，精度0.001kgf。 将检测端垂直置于测量腧穴表面，均匀缓慢加力（100gf/s），至受检者告知局部疼痛时停止，此时测痛仪所示数值即为机械痛阈值，每个部位测量2次，每次至少间隔3min，取平均值记录。若测得的机械痛阈值差值大于0.5kgf，则加测第3次，并取3次测量的均值。 1.3探查方法及判定标准 力敏腧穴探查：参照课题组前期研究，对所有受试者进行腧穴探查，具体步骤如下：遵循先远后近、先健侧后患侧的原则，采用审、切、循、扪、按、提捏探查六法进行探查，当受试者自述有“快然”“疼痛”“非痛觉”等感觉时认为该部位可能发生敏化，并使用马克笔进行标记，所有触诊区域均进行2次触诊，为了减少偏倚，所有受试者均由同一位研究者完成探查。 痛阈值的探查：压痛阈值测定采用手持式测痛仪，产品型号：JNT-CTY，北京翼诺泰科技发展有限公司，探头直径1.05mm，量程0～1kgf，精度0.001kgf。 将检测端垂直置于测量腧穴表面，均匀缓慢加力，至受检者告知局部疼痛时停止，此时测痛仪所示数值即为机械痛阈值，每个部位测量3次，每次至少间隔2min，取平均值记录。 1.4探查范围 第一部分：根据《功能性消化不良中医诊疗专家共识意见（2017）》及《功能性消化不良的中西医结合诊疗共识意见（2010）》选取临床常用穴位中脘、足三里、脾俞、胃俞、内关、天枢、阳陵泉、期门、气海，共9个腧穴。 第二部分：在患者腹部及腰背部进行力敏腧穴探查，范围如下： （1）腹部：将每名受试者腹部区域分为总计9个测试区。 a.上水平线为两侧肋弓下缘最低点的连线； b.下水平线为两侧髂前上棘连线； c.左垂直线为通过左髂前上棘至腹中线连线的中点所作的垂直线； d.右垂直线为通过右髂前上棘至腹中线连线的中点所作的垂直线。 选取上腹部，左上腹部，中腹部，左腹部，共4个测试区。 （2）背腰部：相对应的将每名受试者腰背部分为9个测试区。 a.上水平线为十二胸椎棘突下所作的水平线； b.下水平线为两侧髂棘最高点的连线； c.左垂直线为通过左肩胛骨下角所作的垂直线； d.右垂直线为通过右肩胛骨下角所作的垂直线。 以腋中线作腰腹的前后分界线。 选取一号，二号，四号，五号区，共4个测试区。 腹部与腰背部共计8个测试区，所有受试者探查由同一人完成。 1.5干预腧穴选择 根据痛阈值对所有力敏腧穴进行评级。疼痛阈值最低的5个点被确定为较高的敏感点，而疼痛阈值最高的5个点被选择为较低的敏感点。 1.6治疗方法 （1）高敏组：受试者接受5个高敏感（最低疼痛阈值）腧穴的针刺治疗。选用长40mm、直径0.30mm的无菌、一次性毫针，按中国中医药出版社全国高等中医药院校“十四五”教材《经络腧穴学》规定进行针刺，进针后以平补平泻手法进行刺激，后留针30min，每10min行针一次以维持针感。 （2）低敏组：受试者接受5个低敏感（最高疼痛阈值）腧穴的针刺治疗。所有其他治疗设置与高敏组相同。 疗程：两组均每周5次针刺治疗，共20次针刺治疗。 （3）等待治疗组：受试者在研究期间将不接受任何针灸。出于伦理考虑，我们将在研究完成后提供免费的、非研究性标准10次针灸治疗。参照十四五规划教材《针灸治疗学》中所列处方，取中脘、天枢（双）、足三里（双）、上巨虚（双），不避力敏腧穴，采用平补平泻手法，留针30min。 三组预计于治疗结束4周后进行随访。

Description for medicine or protocol of treatment in detail：

Fourth the treatment plan 1. Force-sensitive acupoint exploration 1.1 Preparation before exploration Choose a quiet well-lit treatment room with a room temperature of 18-25°C ask the patient to rest for 10 minutes and then take a comfortable position avoid other unrelated personnel and fully expose the subject's exploration site. 1.2 Measuring instruments Handheld pain tester is used for the determination of tenderness threshold product model: JNT-CTY Beijing Yinuotai Technology Development Co. Ltd. probe diameter 1.05mm range 0~1kgf accuracy 0.001kgf. The detection end is placed vertically on the surface of the acupoint measured and the force is evenly and slowly applied (100gf/s) until the subject informs the local pain and stops at this time the value shown by the pain meter is the mechanical pain threshold and each part is measured twice with an interval of at least 3min each time and the average value is recorded. If the difference between the measured mechanical pain threshold is greater than 0.5kgf the third test will be added and the average value of the three measurements will be taken. 1.3 Exploration methods and judgment criteria Force-sensitive acupoint exploration: referring to the previous study of the research group all subjects were explored for acupoints and the specific steps were as follows: following the principle of distal first and then near first the healthy side and then the affected side six methods of review cutting following palpation pressing and pinching were used to explore and when the subjects reported feelings such as "happy" "painful" and "non-painful" they thought that the part might be sensitized and marked with a marker and all palpation areas were palpated twice and in order to reduce bias all subjects were explored by the same investigator. Exploration of pain threshold: handheld pain tester is used to determine the pain threshold product model: JNT-CTY Beijing Yinuotai Technology Development Co. Ltd. probe diameter 1.05mm range 0~1kgf accuracy 0.001kgf. The detection end is placed vertically on the surface of the acupoint measured and the force is evenly and slowly applied until the examinee tells the local pain to stop at this time the value shown by the pain meter is the mechanical pain threshold and each part is measured 3 times with an interval of at least 2min each time and the average value is recorded. 1.4 Scope of exploration Part 1: According to the "Expert Consensus on the Diagnosis and Treatment of Functional Indigestion with Traditional Chinese Medicine (2017)" and the "Consensus on the Diagnosis and Treatment of Functional Indigestion with Integrated Traditional Chinese and Western Medicine (2010)" a total of 9 acupoints were selected: Zhongguan Zusanli Spleen Yu Stomach Yu Neiguan Tianshu Yanglingquan Qimen and Qihai. Part 2: Force-sensitive acupoint exploration on the patient's abdomen and lower back covering the following areas: (1) Abdomen: The abdominal area of each subject was divided into a total of 9 test areas. a. The upper horizontal line is the line connecting the lowest point of the lower edge of the costal arch on both sides; b. The inferior horizontal line is the line connecting the anterior superior iliac spines on both sides; c. The left vertical line is the vertical line made through the midpoint of the line connecting the left anterior superior iliac spine to the ventral midline; d. The right vertical line is the vertical line made through the midpoint of the line connecting the right anterior superior iliac spine to the ventral midline. The upper abdomen left upper abdomen middle abdomen and left abdomen were selected for a total of 4 test areas. (2) Back and waist: The corresponding part of each subject's back is divided into 9 test areas. a. The upper horizontal line is the horizontal line made under the spinous processes of the twelve thoracic vertebrae; b. The lower horizontal line is the highest point of the iliac spines on both sides c. The left vertical line is the vertical line made through the lower corner of the left scapula; d. The right vertical line is the vertical line made through the lower corner of the right shoulder blade. The midaxillary line is used as the anterior-posterior dividing line of the waist and abdomen. Select No. 1 No. 2 No. 4 and No. 5 areas a total of 4 test areas. There are a total of 8 testing areas in the abdomen and lower back and all subjects are explored by the same person. 1.5 Intervention in acupoint selection All force-sensitive acupoints were rated according to the pain threshold. The 5 points with the lowest pain threshold were identified as the higher sensitivity points while the 5 points with the highest pain threshold were selected as the lower sensitivity points. 1.6 Treatment (1) High-sensitivity group: Subjects received acupuncture treatment with 5 high-sensitivity (lowest pain threshold) acupoints. A sterile disposable millineedle with a length of 40mm and a diameter of 0.30mm was selected for acupuncture according to the provisions of the "14th Five-Year Plan" textbook "Meridians and Acupoints" of the National Higher Chinese Medicine Colleges and Universities of China Publishing House. (2) Low-sensitivity group: Subjects received acupuncture treatment with 5 low-sensitivity (highest pain threshold) acupoints. All other treatment settings were the same as in the high-sensitivity group. Treatment course: Both groups were treated with acupuncture 5 times a week a total of 20 acupuncture treatments. (3) Waiting treatment group: Subjects will not receive any acupuncture during the study. For ethical reasons we will provide a free non-investigational standard of 10 acupuncture treatments after the study is completed. Referring to the prescriptions listed in the textbook "Acupuncture and Moxibustion Therapeutics" in the 14th Five-Year Plan take Zhongguan Tianshu (double) Zusanli (double) and Shangjuxu (double) do not avoid the force sensitive acupoints use the flat supplement and flattening laxative technique and leave the needle for 30min. The three groups are expected to be followed up 4 weeks after the end of treatment.

纳入标准：

纳入标准 （1）须符合罗马Ⅳ的功能性消化不良的诊断标准。 （2）年龄范围18至75岁之间。 （3）病程超过6个月以上。 （4）实验研究开始前至少15天内没有服用过任何胃肠促动力药，且未进行相关针刺治疗。 （5）未参与其他临床研究。 （6）自愿签署相关知情同意书，自愿参加本临床课题。 （同时符合上述纳入标准的患者才可纳入本项研究）

Inclusion criteria

Inclusion Criteria: (1) Must meet the diagnostic criteria for functional dyspepsia of Rome IV. (2) Age range: between 18 and 75 years old. (3) The course of the disease is more than 6 months. (4) Have not taken any gastrointestinal prokinetic drugs at least 15 days before the start of the experimental study and have not undergone relevant acupuncture therapy. (5) Not participating in other clinical studies. (6) Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical topic. (Only patients who meet the above inclusion criteria will be included in this study)

排除标准：

排除标准 有以下任何情况之一者，必须排除。 （1）合并心血管、内分泌、肝、肾、消化系统以及肿瘤、神经精神类疾病者。 （2）处于妊娠期、哺乳期的女性。 （3）伴严重抑郁、焦虑症状者。 （4）严重惧针、金属过敏或者过敏体质者。 （5）患者不服从随机分配入组治疗或有依从性差等不稳定倾向的。 （6）正在参与其他影响本课题试验结果的其他课题研究或不愿签署知情同意书者。

Exclusion criteria：

Exclusion Criteria: Any of the following conditions must be excluded. (1) Patients with cardiovascular endocrine liver kidney digestive system tumor neuropsychiatric diseases. (2) Women who are pregnant or breastfeeding. (3) Those with severe depression and anxiety symptoms. (4) Those who are severely allergic to needles and metals or have allergies. (5) The patient does not obey the randomized enrollment treatment or has an unstable tendency such as poor compliance. (6) Those who are participating in other research projects that affect the results of the subject or are unwilling to sign the informed consent form.

研究实施时间：

Study execute time：

从From 2024-08-22

至To      2025-08-21

征募观察对象时间：

Recruiting time：

从From 2024-08-22

至To      2025-01-21

干预措施：

Interventions：

组别：

低敏组

样本量：

20

Group：

Hypoallergenic group

Sample size：

干预措施：

针刺五个低敏感腧穴

干预措施代码：

Intervention：

Acupuncture of five hyposensitive acupoints

Intervention code：

组别：

高敏组

样本量：

20

Group：

High sensitivity group

Sample size：

干预措施：

针刺五个高敏感腧穴

干预措施代码：

Intervention：

Acupuncture of five highly sensitive acupoints

Intervention code：

组别：

等待治疗组

样本量：

20

Group：

Waiting for treatment group

Sample size：

干预措施：

不做任何治疗

干预措施代码：

Intervention：

No treatment is done

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江西省

市(区县)：

南昌市

Country：

China

Province：

Jiangxi Province

City：

Nanchang city

单位(医院)：

江西中医药大学附属医院

单位级别：

三甲医院

Institution/hospital：

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

Zung氏焦虑量表

指标类型：

次要指标

Outcome：

SAS

Type：

Secondary indicator

测量时间点：

针刺治疗当天、第4周

测量方法：

量表

Measure time point of outcome：

On the day of acupuncture treatment and in the fourth week

Measure method：

Scales

指标中文名：

尼平消化不良指数

指标类型：

主要指标

Outcome：

Nepean dyspepsia indexNDI

Type：

Primary indicator

测量时间点：

在针刺治疗的当天、第2、第4周

测量方法：

量表

Measure time point of outcome：

On the day of acupuncture treatment the 2nd and 4th weeks

Measure method：

Scales

指标中文名：

非靶向代谢组学检测指标

指标类型：

附加指标

Outcome：

Non-targeted metabolomics detection indicators

Type：

Additional indicator

测量时间点：

治疗前以及治疗后

测量方法：

液相质谱仪检测

Measure time point of outcome：

Before and after treatment

Measure method：

Liquid chromatography mass spectrometry detection

指标中文名：

Zung氏抑郁量表

指标类型：

次要指标

Outcome：

SDS

Type：

Secondary indicator

测量时间点：

针刺治疗当天、第4周

测量方法：

量表

Measure time point of outcome：

On the day of acupuncture treatment and in the fourth week

Measure method：

Scales

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Human blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

张格通过第三方的临床试验管理系统（http://h6world.cn/）来完成随机化。首先当受试者符合纳入标准时进行受试者登记，主要包括姓名、出生日期、年龄、性别、病程、民族、事先规定的预后因素（分层因素选择性别和年龄，保证患者在基线特征上具有可比性），登记后每个受试者会获得一个受试者ID。获得受试者ID后即可由系统进行随机分组。可以确保随机化的准确性，更好的避免主观选择偏倚。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Ge Zhang used a third-party clinical trial management system (http://h6world.cn/) to complete randomization. Firstly when the subjects meet the inclusion criteria the subjects are registered mainly including name date of birth age gender course of disease ethnicity pre-specified prognostic factors (gender and age are selected as stratification factors to ensure that patients are comparable in baseline characteristics) and each subject will be given a subject ID after registration. Once the subject ID is obtained the system can randomize the group. It can ensure the accuracy of randomization and better avoid subjective selection bias.

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

如有需要，邮件联系课题负责人获取

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

If necessary please contact the project leader by email

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据搜集管理由纸质CRF表进行搜集

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection management is carried out by paper CRF forms

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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