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基于NLRP3/caspase-1/GSDMD/IL-1β通路观察自血穴位注射治疗变应性鼻炎的临床疗效及其机制探索

注册号：

Registration number：

ITMCTR2025001449

最近更新日期：

Date of Last Refreshed on：

2025-07-20

注册时间：

Date of Registration：

2025-07-20

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于NLRP3/caspase-1/GSDMD/IL-1β通路观察自血穴位注射治疗变应性鼻炎的临床疗效及其机制探索

Public title：

To observe the clinical efficacy and mechanism exploration of autologous blood acupoint injection in the treatment of allergic rhinitis based on the NLRP3/caspase-1/GSDMD/IL-1β pathway

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于NLRP3/caspase-1/GSDMD/IL-1β通路观察自血穴位注射治疗变应性鼻炎的临床疗效及其机制探索

Scientific title：

To observe the clinical efficacy and mechanism exploration of autologous blood acupoint injection in the treatment of allergic rhinitis based on the NLRP3/caspase-1/GSDMD/IL-1β pathway

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：

刘琦

研究负责人：

彭顺林

Applicant：

LiuQi

Study leader：

PengShunlin

申请注册联系人电话：

Applicant telephone：

18190997207

研究负责人电话：

Study leader's telephone：

18980880161

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：

726576233@qq.com

研究负责人电子邮件：

Study leader's E-mail：

726576233@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：

四川省成都市金牛区西安路街道十二桥路37号成都中医药大学

研究负责人通讯地址：

四川省成都市金牛区西安路街道十二桥路37号成都中医药大学

Applicant address：

No. 37 Shierqiao Road Xi 'an Road Sub-district Jinniu District Chengdu City Sichuan Province Chengdu University of Traditional Chinese Medicine

Study leader's address：

No. 37 Shierqiao Road Xi 'an Road Sub-district Jinniu District Chengdu City Sichuan Province Chengdu University of Traditional Chinese Medicine

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：

成都中医药大学附属医院

Applicant's institution：

Affiliated Hospital of Chengdu 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：

2025KL-105

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：

成都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 Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/7/2 0:00:00

伦理委员会联系人：

何清

Contact Name of the ethic committee：

HeQing

伦理委员会联系地址：

四川省成都市金牛区成都中医药大学附属医院

Contact Address of the ethic committee：

Chengdu University of Traditional Chinese Medicine Affiliated Hospital Jinniu District Chengdu City Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

028-87783142

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ethicscd@126.com

研究实施负责（组长）单位：

四川省成都市金牛区成都中医药大学附属医院

Primary sponsor：

Chengdu University of Traditional Chinese Medicine Affiliated Hospital Jinniu District Chengdu City Sichuan Province

研究实施负责（组长）单位地址：

四川省成都市金牛区十二桥路39-41号成都中医药大学附属医院

Primary sponsor's address：

No. 39-41 Shierqiao Road Jinniu District Chengdu City Sichuan Province Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都中医药大学附属医院

具体地址：

四川省成都市金牛区成都中医药大学附属医院

Institution
hospital：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Address：

Chengdu University of Traditional Chinese Medicine Affiliated Hospital Jinniu District Chengdu City Sichuan Province

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

变应性鼻炎

研究疾病代码：

Target disease：

Allergic rhinitis

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：

本课题旨在基于NLRP3/caspase-1/GSDMD/IL-1β通路观察自血穴位注射治疗变应性鼻炎的有效性和安全性及其机制研究，以期为自血穴位注射治疗变应性鼻炎提供更可靠的循证依据，发掘更经济、更简便、更安全的治疗变应性鼻炎手段。

Objectives of Study：

This project aims to observe the efficacy safety and mechanism of autologous blood acupoint injection in the treatment of allergic rhinitis based on the NLRP3/caspase-1/GSDMD/IL-1β pathway with the aim of providing more reliable evidence-based evidence for autologous blood acupoint injection in the treatment of allergic rhinitis and exploring more economical simpler and safer treatment methods for allergic rhinitis.

药物成份或治疗方案详述：

1.自血穴位注射组（A-AHT）： 选穴：双侧足三里、双侧肺俞、双侧肾俞 选穴依据：足三里为足阳明胃经合穴、胃下合穴，具有健脾和胃，舒经活络，强壮保健功效；肺俞为肺之背腧穴，具有宣肺理气，舒经活络，祛风止痒功效；肾俞为肾之背腧穴，具有补肾填精功效；三穴合用，共奏调理肺脾肾、补益元气、祛风止痒之功。 定位：穴位具体的定位方法参照2006年版的中华人民共和国国家标准（GB/T 12346-2006）《腧穴名称与定位》。足三里（ST36）：在小腿外侧，犊鼻（ST35）下3寸，犊鼻与解溪（ST41）连线上，胫骨前肌上取穴。肺俞（BL13）：在背部，第3胸椎棘突下，后正中线旁开1.5寸。肾俞（BL23）：在腰部，第2腰椎棘突下，后正中线旁开1.5寸。 材料：５ml一次性无菌注射器（上海康德莱企业发展集团股份有限公司生 产），0.２％ 碘伏。 操作方法：受试者予以佩戴黑色眼罩，用0.2%碘伏对局部皮肤进行常规消毒后，用５ｍl一次性无菌注射器抽取受试者肘静脉血2ml，令受试者用无菌干棉球局部按压针孔3分钟。穴位皮肤常规消毒后,将注射针头刺入该受试者双侧的足三里穴或双侧肺俞穴或双侧肾俞穴。刺入穴位得气后，回抽无血后予每穴位缓慢注入１ｍl静脉血 ，整个过程在3 min内完成。注射完毕后嘱受试者休息10 min，观察其是否有不适。每周注射２次 （ 每３天１次，第２次多休息一天）。治疗４周，共８次，三组穴位交替使用。所有病例操作者为经过培训并考核合格的具有丰富临床操作经验的医生。 2.穴位注射生理盐水组(A-NS)： 选穴、选穴依据、定位均同自血穴位注射组。 材料：５ml一次性无菌注射器（上海康德莱企业发展集团股份有限公司生 产），0.２% 碘伏、0.9%氯化钠注射液。 操作方法：受试者予以佩戴黑色眼罩，用0.2%碘伏对局部皮肤进行常规消毒后，用５mL一次性无菌注射器抽取受试者肘静脉血2ml。穴位皮肤常规消毒后,另取一５mL一次性注射器抽取0.9%氯化钠注射液2ml，注射针头刺入该病人双侧的足三里穴或双侧肺俞穴或双侧肾俞穴。刺入穴位得气后，回抽无血后予每穴位缓慢注入１ｍl生理盐水。注射完毕后嘱患者休息10 min，观察其是否有不适。每周注射２次 （ 每３天１次，第２次多休息一天）。治疗４周，共８次，三组穴位交替使用。所有病例操作者为经过培训并考核合格的具有丰富临床操作经验的医生。 3.假穴假注射治疗组(s-AT)： 假穴假注射治疗组的患者将接受在非穴位处进行非穿透性假注射治疗。在该组中，假注射治疗将由自制的注射器带钝针在非穴位处进行。操作者使用钝针进行假注射时，钝头接触皮肤，不会有得气的感觉，亦不会穿透皮肤。表1显示了沿经络分布的不同于传统穴位的非穴位的位置详情。 操作方法：受试者予以佩戴黑色眼罩，用0.2%碘伏对局部皮肤进行常规消毒后，用５mL一次性无菌注射器抽取受试者肘静脉血2ml。穴位皮肤常规消毒后,使用自制的注射器带钝针刺激该受试者的与传统穴位相对应的非穴位位置，操作技术与自血穴位注射治疗组相同，操作完毕后嘱患者休息10 min，观察其是否有不适。每周治疗２次 （ 每３天１次，第２次多休息一天）。治疗４周，共８次，三组穴位交替使用。所有病例操作者为经过培训并考核合格的具有丰富临床操作经验的医生。

Description for medicine or protocol of treatment in detail：

Autologous blood acupoint injection group (A-AHT) : Acupoints selected: Zusanli on both sides Feishu on both sides Shenshu on both sides The basis for selecting acupoints: Zusanli is the Hehe and Xiahe acupoints of the foot Yangming stomach. It has the functions of strengthening the spleen and stomach relaxing the meridians and activating the collaterals and promoting health and strengthening the body. Feishu is the back-shu point of the lung which has the functions of promoting lung function and regulating qi relaxing meridians and activating collaterals dispelling wind and relieving itching. Shenshu is the back-shu point of the kidney and has the function of tonifying the kidney and replenishing essence. When the three acupoints are used in combination they jointly achieve the effects of regulating the lungs spleen and kidneys tonifying the vital energy dispelling wind and relieving itching. Location: The specific location methods for acupoints shall refer to the 2006 edition of the National Standard of the People's Republic of China (GB/T 12346-2006) "Names and Locations of Acupoints". Zusanli (ST36) : Located on the outer side of the lower leg 3 cun below Dubi (ST35) on the line connecting Dubi and Jiexi (ST41) on the tibialis anterior muscle. Feishu (BL13) : Located on the back 1.5 cun lateral to the posterior midline below the spinous process of the third thoracic vertebra. Shenshu (BL23) : Located at the waist 1.5 cun lateral to the posterior midline below the spinous process of the second lumbar vertebra. Materials: 5ml disposable sterile syringe (produced by Shanghai Kangdelai Enterprise Development Group Co. LTD.) 0.2% iodophor. Operation method: The subjects were required to wear black eye masks. The local skin was routinely disinfected with 0.2% iodophor. Then 2ml of blood was drawn from the subjects' elbow veins using a 5ml disposable sterile syringe. The subjects were asked to press the needle holes locally with a sterile dry cotton ball for 3 minutes. After routine disinfection of the skin at the acupoints the injection needles were inserted into the Zusanli acupoint Feishu acupoint or Shenshu acupoint on both sides of the subject. After the acupoints are punctured to obtain qi the blood is drawn back and then 1ml of venous blood is slowly injected into each acupoint. The entire process is completed within 3 minutes. After the injection was completed the subjects were instructed to rest for 10 minutes to observe if they felt any discomfort. Inject twice a week (once every three days with an additional day off for the second injection). The treatment lasted for 4 weeks with a total of 8 sessions and the three groups of acupoints were used alternately. All case operators are doctors who have received training and passed the assessment and have rich clinical operation experience. 2. Acupoint injection of normal saline group (A-NS) : The selection of acupoints the basis for selection and the location were all the same as those in the autologous blood acupoint injection group. Materials: 5ml disposable sterile syringe (produced by Shanghai Kangdelai Enterprise Development Group Co. LTD.) 0.2% iodophor 0.9% sodium chloride injection. Operation method: The subjects were required to wear black eye masks. After routine disinfection of the local skin with 0.2% iodophor 2ml of blood was drawn from the subjects' elbow veins using a 5mL disposable sterile syringe. After routine disinfection of the skin at the acupoints take another 5mL disposable syringe to draw 2ml of 0.9% sodium chloride injection. Insert the injection needle into the Zusanli acupoint Feishu acupoint or Shenshu acupoint on both sides of the patient. After the acupoints are punctured to obtain qi the blood is drawn back and then 1ml of normal saline is slowly injected into each acupoint. After the injection is completed instruct the patient to rest for 10 minutes and observe if they feel any discomfort. Inject twice a week (once every three days with an additional day off for the second injection). The treatment lasted for 4 weeks with a total of 8 sessions and the three groups of acupoints were used alternately. All case operators are doctors who have received training and passed the assessment and have rich clinical operation experience. 3. Sham point Sham injection treatment group (s-AT) : Patients in the sham acupoint sham injection treatment group will receive non-penetrating sham injection treatment at non-acupoint sites. In this group sham injection treatment will be carried out using a self-made syringe with a blunt needle at non-acupoint locations. When the operator uses a blunt needle for a fake injection the blunt tip touching the skin will not cause a feeling of getting angry nor will it penetrate the skin. Table 1 shows the detailed locations of non-acupoints along the meridians that are different from traditional acupoints. Operation method: The subjects were required to wear black eye masks. After routine disinfection of the local skin with 0.2% iodophor 2ml of blood was drawn from the subjects' elbow veins using a 5mL disposable sterile syringe. After routine disinfection of the skin at the acupoints a self-made syringe with a blunt needle was used to stimulate the non-acupoint positions corresponding to the traditional acupoints of the subject. The operation technique was the same as that of the autologous blood acupoint injection treatment group. After the operation was completed the patient was instructed to rest for 10 minutes to observe whether they felt any discomfort. The treatment is administered twice a week (once every three days with an additional day off for the second session). The treatment lasted for 4 weeks with a total of 8 sessions and the three groups of acupoints were used alternately. All case operators are doctors who have received training and passed the assessment and have rich clinical operation experience.

纳入标准：

①　符合上述诊断标准 ②　年龄18-70周岁（含18和70周岁），性别不限； ③　具备理解研究性质的能力，同意参加本次试验并签署知情同意书者。

Inclusion criteria

① Meet the above diagnostic criteria ② Age: 18 to 70 years old (inclusive) gender not limited; ③ Those who have the ability to understand the nature of the research agree to participate in this trial and sign the informed consent form.

排除标准：

①　合并鼻窦炎、中耳炎、鼻息肉、鼻中隔偏曲等耳鼻喉科感染或器质性病变的； ②　年龄18岁以下或70岁以上； ③　妊娠期或哺乳期妇女 ； ④　合并有心血管、肝、肾和造血系统等严重原发性疾病，精神病患者及影响其生存质量的严重疾病的； ⑤　近１个月内使用过抗组胺药或皮质类固醇药物，接受过中医针灸治疗及其他相关治疗影响疗效判断的。

Exclusion criteria：

① Those with concurrent otorhinolaryngological infections or organic lesions such as sinusitis otitis media nasal polyps and deviated nasal septum; ② Under 18 years old or over 70 years old; ③ Pregnant or lactating women; ④ Those with severe primary diseases such as cardiovascular liver kidney and hematopoietic system diseases mental patients and serious diseases that affect their quality of life; ⑤ Those who have used antihistamines or corticosteroids within the past month or received traditional Chinese acupuncture treatment or other related treatments that affect the judgment of therapeutic effects.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2027-01-01

征募观察对象时间：

Recruiting time：

从From 2025-08-01

至To      2026-01-01

干预措施：

Interventions：

组别：

假穴假注射治疗组

样本量：

14

Group：

Fake acupoint and fake injection treatment group

Sample size：

干预措施：

假穴假注射治疗

干预措施代码：

Intervention：

False acupoint and false injection treatment

Intervention code：

组别：

穴位注射生理盐水组

样本量：

14

Group：

Acupoint injection of normal saline group

Sample size：

干预措施：

穴位注射生理盐水

干预措施代码：

Intervention：

Inject normal saline at acupoints

Intervention code：

组别：

自血穴位注射组

样本量：

14

Group：

Autologous blood acupoint injection group

Sample size：

干预措施：

自血穴位注射

干预措施代码：

Intervention：

Autologous blood injection at acupoints

Intervention code：

样本总量 Total sample size ： 42

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都中医药大学附属医院

单位级别：

三甲医院

Institution/hospital：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Grade-a tertiary hospital

测量指标：

Outcomes：

指标中文名：

血清IgE

指标类型：

次要指标

Outcome：

Serum IgE

Type：

Secondary indicator

测量时间点：

基线期和第四周

测量方法：

ELISA法

Measure time point of outcome：

Baseline period and the fourth week

Measure method：

ELISA method

指标中文名：

血清IL-1β

指标类型：

次要指标

Outcome：

Serum IL-1β

Type：

Secondary indicator

测量时间点：

基线期和第四周

测量方法：

ELISA法

Measure time point of outcome：

Baseline period and the fourth week

Measure method：

ELISA method

指标中文名：

鼻部症状总评分

指标类型：

主要指标

Outcome：

Total Nasal Symptom Score

Type：

Primary indicator

测量时间点：

基线期、第2周、第4周、第5周、第6周、第7周、第8周

测量方法：

问卷

Measure time point of outcome：

Baseline period, Week 2, Week 4, week 5, week 6, Week 7, Week 8

Measure method：

Questionnaire

指标中文名：

非鼻部症状总评分

指标类型：

主要指标

Outcome：

Total Non-nasal Symptom Score

Type：

Primary indicator

测量时间点：

基线期、第2周、第4周、第5周、第6周、第7周、第8周

测量方法：

问卷

Measure time point of outcome：

Baseline period, Week 2, Week 4, week 5, week 6, Week 7, Week 8

Measure method：

Questionnaire

指标中文名：

鼻结膜炎生活质量评分

指标类型：

主要指标

Outcome：

Rhinoconjunctivitis Quality of Life Questionnaire

Type：

Primary indicator

测量时间点：

基线期、第4周、第6周、第8周

测量方法：

问卷

Measure time point of outcome：

Baseline period, week 4, week 6, Week 8

Measure method：

Questionnaire

指标中文名：

体征评分

指标类型：

主要指标

Outcome：

Physical sign score

Type：

Primary indicator

测量时间点：

基线期、第2周、第4周、第5周、第6周、第7周、第8周

测量方法：

量化评分

Measure time point of outcome：

Baseline period, Week 2, Week 4, week 5, week 6, Week 7, Week 8

Measure method：

Quantitative scoring

指标中文名：

鼻黏膜组织中NLRP3

指标类型：

次要指标

Outcome：

NLRP3 in nasal mucosa tissue

Type：

Secondary indicator

测量时间点：

第4周

测量方法：

Ｗestern blot法

Measure time point of outcome：

The fourth week

Measure method：

Ｗestern blot method

指标中文名：

鼻粘膜组织中caspase-1

指标类型：

次要指标

Outcome：

caspase-1 in nasal mucosa tissue

Type：

Secondary indicator

测量时间点：

第4周

测量方法：

Ｗestern blot法

Measure time point of outcome：

The fourth week

Measure method：

Ｗestern blot method

指标中文名：

鼻粘膜组织中GSDMD

指标类型：

次要指标

Outcome：

GSDMD in nasal mucosa tissue

Type：

Secondary indicator

测量时间点：

第4周

测量方法：

Ｗestern blot

Measure time point of outcome：

The fourth week

Measure method：

Ｗestern blot method

指标中文名：

血清IL-10

指标类型：

次要指标

Outcome：

Serum IL-10

Type：

Secondary indicator

测量时间点：

基线期和第四周

测量方法：

ELISA method

Measure time point of outcome：

Baseline period and the fourth week

Measure method：

ELISA

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

粘膜组织

组织：

鼻部

Sample Name：

mucosa tissue

Tissue：

nasal

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

血液

组织：

Sample Name：

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 70 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）：

本研究采用SPSS软件进行随机分组，利用SPSS 26.0软件“转换-计算变量”和“转换-可视分箱”菜单生成随机组别，受试者按就诊顺序对应到相应的组别进行相应的治疗方案。

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

In this study SPSS software was used for random grouping. The random groups were generated using the "Conversion - Calculation of Variables" and "Conversion - Visual Grouping" menus of SPSS 26.0 software. The subjects were assigned to the corresponding groups according to the order of their visits and received the corresponding treatment plans.

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）：

/

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

/

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：

病例记录表

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

Case Record Form CRF

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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