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宣肺通窍针法结合蝶腭神经节刺法治疗变应性鼻炎的多中心临床研究

注册号：

Registration number：

ITMCTR2024000382

最近更新日期：

Date of Last Refreshed on：

2024-09-05

注册时间：

Date of Registration：

2024-09-05

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

宣肺通窍针法结合蝶腭神经节刺法治疗变应性鼻炎的多中心临床研究

Public title：

A multicenter clinical study of Xuan Lung Tong Qiao acupuncture combined with pterygopalatine ganglion stabbing in the treatment of allergic rhinitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

宣肺通窍针法结合蝶腭神经节刺法治疗变应性鼻炎的多中心临床研究

Scientific title：

A multicenter clinical study of Xuan Lung Tong Qiao acupuncture combined with pterygopalatine ganglion stabbing in the treatment of allergic rhinitis

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：

李国宇

研究负责人：

彭拥军

Applicant：

LiGuoYu

Study leader：

PengYongJun

申请注册联系人电话：

Applicant telephone：

18811303073

研究负责人电话：

Study leader's telephone：

13770671498

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：

1355062384@qq.com

研究负责人电子邮件：

Study leader's E-mail：

pengyongjun2004@126.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：

江苏省南京市南京中医药大学汉中门校区

研究负责人通讯地址：

江苏省南京市秦淮区汉中路155号

Applicant address：

Hanzhongmen Campus Nanjing University of Traditional Chinese Medicine Nanjing Jiangsu Province China

Study leader's address：

No.155 Hanzhong Road Qinhuai District Nanjing Jiangsu Province China

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：

江苏省中医院

Applicant's institution：

Jiangsu Provincial Hospital 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：

2024NL-060-02

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：

南京中医药大学附属医院（江苏省中医院）伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

伦理委员会批准日期：

Date of approved by ethic committee：

2024/4/24 0:00:00

伦理委员会联系人：

王卯

Contact Name of the ethic committee：

WangMao

伦理委员会联系地址：

江苏省南京市秦淮区汉中路155号江苏省中医院

Contact Address of the ethic committee：

Jiangsu Provincial Hospital of Traditional Chinese Medicine No. 155 Hanzhong Road Qinhuai District Nanjing Jiangsu Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+862586560515

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1355062384@qq.com

研究实施负责（组长）单位：

江苏省中医院

Primary sponsor：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市秦淮区汉中路155号

Primary sponsor's address：

No.155 Hanzhong Road Qinhuai District Nanjing Jiangsu Province China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu Province

City：

单位(医院)：

江苏省中医院

具体地址：

江苏省南京市秦淮区汉中路155号

Institution
hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address：

No.155 Hanzhong Road Qinhuai District Nanjing Jiangsu Province China

经费或物资来源：

国家中医针灸临床医学研究中心

Source(s) of funding：

National Clinical Medical Research Center of Chinese Medicine and Acupuncture

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过临床观察宣肺通窍针法治疗变应性鼻炎（allergic rhinitis,AR）患者的临床疗效、复发率及安全性；通过对比治疗前后 AR 患者鼻症状总分（TNSS 评分）、鼻炎伴随症状总分表（TNNSS）、鼻结膜炎生命质量调查问卷（RQLQ）、视觉评分量表（VAS）等方面比较三组的疗效差异，明确宣肺通窍针法与蝶腭神经节刺法治疗变应性鼻炎的近期、远期疗效及安全性，以及是否具有协同增效作用。

Objectives of Study：

The clinical efficacy, recurrence rate and safety of Xuanlong Tongjiao Acupuncture in the treatment of allergic rhinitis (AR) were observed. The differences in the efficacy of the three groups were compared in terms of the Total Nasal Symptom Score (TNSS score), Total Nasal Nasal Symptoms Score Scale (TNNSS), Rhinoconjunctivitis Questionnaire (RQLQ), and Visual Appraisal Scale (VAS) of the AR patients before and after the treatment. We compared the efficacy differences among the three groups, and clarified the immediate and long-term efficacy and safety of Xuanlong Tongjiao acupuncture and pterygopalatine ganglion stabbing in the treatment of allergic rhinitis, as well as whether they have synergistic effects.

药物成份或治疗方案详述：

治疗方案 实验分组： 宣肺通窍针法组 根据随机数字表法随机选取 AR 患者。对观察对象于复诊 1 周、2 周、4 周、 8 周时进行记录，并于治疗前、第 8 周治疗结束后采集血样标本，备测。 针刺方法：针具为华佗牌一次性使用无菌针灸针（0.30×40mm），由苏州医 疗用品厂提供。 选穴：迎香、鼻通、印堂、风池、列缺、合谷、足三里、三阴交。 操作：取仰卧位，常规消毒后，迎香穴针尖透向鼻通穴,得气后用强刺激手法运 针 30s，使整个鼻腔及周围有强烈酸胀感；鼻通穴针尖向内上方斜刺，使感应扩 散至鼻根部，针刺诸穴；印堂穴进针后深达鼻根处，使针感扩散至鼻尖部；双风 池穴向鼻尖方向透刺；合谷、列缺、足三里、三阴交穴分别按常规针刺 0.5-1 寸。治疗组隔日针刺 1 次，每周针刺 3 次，连续治疗 8 周，后统计临床疗效。因 该病缠绵难愈，建议病人坚持治疗，以达到最佳治疗效果。 蝶腭神经节刺法组 选取入组的 AR 患者， 体位：患者取仰卧位（头偏向对侧），术者坐于患者治疗侧。 消毒：75%酒精消毒皮肤。 针具：选用 0.35mm×55mm 一次性无菌针灸针。 定点：皮肤定位：从颧弓下缘与下颌骨冠突后缘骨间隙（可以让患者做张口闭口 动作，能感觉到活动的骨面即为冠突，在其后缘定点）。 操作：“押手”按压定点处皮肤，“刺手”沿“押手”指甲缘进针，针尖朝对侧太 阳穴刺入，相当于定点位置的内上方，稍偏前。 针感：针刺进入约 55mm，刺中会出现鼻周、上唇部、鼻唇沟周围放电样、鼻腔 喷水样、通气样感觉。刺中即出针。术后用干棉球按压针眼 3min。 疗程：依据病情确定疗程：单侧治疗，双侧交替，特别严重可双侧同时治疗，每 周治疗 1 次,8 次作为 1 个疗程，治疗 1 个疗程后统计临床疗效。 宣肺通窍针法结合蝶腭神经节刺法组 宣肺通窍针法、蝶腭神经节刺法取穴、针法及疗程同前。

Description for medicine or protocol of treatment in detail：

Experimental grouping: Xuan Lung Tong Qiao group AR patients were randomly selected according to the randomized numerical table method. Recordings were made at 1 week, 2 weeks, 4 weeks and 8 weeks of follow-up for the observation subjects, and blood specimens were collected before treatment and at the end of the 8th week of treatment for measurement. Acupuncture methods: The needles were Huatuo brand sterile single-use acupuncture needles (0.30×40 mm), provided by Suzhou Medical Supplies Factory. Selected points: Yingxiang, Bitong, Yintang, Fengchi, Lianjiao, Hegu, Ashigaru, Sanyinjiao. Operation: in supine position, after routine disinfection, the needle tip of Yingxiang point was directed to the nasal passage point, and the needle was transported with strong stimulation for 30s after getting qi, so that the whole nasal cavity and the surrounding area had a strong feeling of acidity and distension; the needle tip of the nasal passage point was stabbed obliquely upward inward, so that the sensation was diffused to the root of the nose, and the acupuncture points were stabbed; the needle tip of the Yintang point was inserted deeply into the root of the nose, and the sensation of the needle was diffused to the tip of the nose; the two Fengchi points were stabbed in the direction of the tip of the nose; and the Hetu, Lekou, Ashigarashiri, and Sanyinjiao points were stabbed with 0.5 mm of needle tip respectively according to the conventional method. Hetu, Lianqiu, Ashigaru and Sanyinjiao points were needled 0.5-1 inch respectively according to the routine. In the treatment group, acupuncture was performed once every other day and three times a week for 8 weeks, and the clinical efficacy of the treatment was calculated later. Because the disease is difficult to be cured, it is recommended that the patients insist on the treatment in order to achieve the best therapeutic effect. Pterygopalatine ganglion acupuncture group Selected AR patients in the group, position: the patient takes the supine position (the head is inclined to the opposite side), the operator sits on the patient's treatment side. Sterilization: 75% alcohol was used to sterilize the skin. Needles: 0.35mm×55mm sterile disposable acupuncture needles were used. Positioning: Skin positioning: from the lower edge of the zygomatic arch and the bone gap at the posterior edge of the mandibular coronoid process (you can ask the patient to open and close his/her mouth, and the bone surface where he/she can feel the movement is the coronoid process, and the point is set at the posterior edge of the coronoid process). Operation: The "betting hand" presses the skin at the fixed point, the "stabbing hand" enters the needle along the edge of the nail of the "betting hand", and the tip of the needle is inserted towards the contralateral Taiyang acupoint, which is equivalent to the inner and upper part of the fixed point, slightly in front of it. Needle sensation: The needle is inserted about 55mm, and there will be a discharge-like sensation around the nose, upper lip and nasolabial groove, and a nasal spray-like sensation and ventilation-like sensation when the needle is inserted. The needle is discharged as soon as it is inserted. After the operation, press the eye of the needle with a dry cotton ball for 3 minutes. Treatment: the treatment course is determined according to the condition: unilateral treatment, bilateral treatment alternately, especially serious bilateral treatment at the same time, treatment once a week, 8 times as a course of treatment, clinical efficacy of the treatment after a course of treatment statistics. Xuanlong Tongjiao acupuncture combined with pterygopalatine ganglion stabbing group Xuanlong Tongjiao acupuncture and pterygopalatine ganglion stabbing methods were the same as the previous group in terms of the points taken, the acupuncture method and the course of treatment.

纳入标准：

① 符合中西医诊断的常年性中重度 AR 患者，且症状和体征总分 8～12 分； ② 签署知情同意书的患者； ③ 年龄在 18～65 岁之间； ④ 入组前 6 个月内无哮喘发作史及其他变应性疾病史； ⑤ 入组前 1 周内未使用过糖皮质激素，1 周内未使用过 H1抗组胺药、白三

Inclusion criteria

(1) Patients with moderate to severe AR with symptoms and signs of 8 to 12 points in both Chinese and Western medicine; (2) Patients who have signed an informed consent form; (3) Patients aged between 18 and 65; (4) No history of asthma attacks or other allergic diseases in the 6 months before enrollment; (5) No glucocorticosteroids in the week prior to enrollment, and no use of H1 antihistamines, leukotrienes, etc. in the week prior to enrollment; (6) Patients with asthma attacks or other allergic diseases in the 6 months prior to enrollment; (7) Patients with asthma attacks or allergic diseases in the week prior to enrollment.

排除标准：

① 血管运动性鼻炎、非变应性鼻炎伴嗜酸性粒细胞增多综合征、感染性鼻 炎、激素性鼻炎、药物性鼻炎等其他相关性鼻炎者； ② 合并严重器官组织功能障碍、肿瘤、感染性疾病、精神病者； ③ 妊娠期妇女； ④ 不能配合治疗、资料不全影响疗效判定者。

Exclusion criteria：

① vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, infectious rhinitis, hormonal rhinitis, drug-induced rhinitis and other related rhinitis; ② combined with severe organ and tissue dysfunction, tumors, infectious diseases, mental illness; ③ pregnant women; ④ unable to cooperate with the treatment, incomplete information affects the efficacy of the judgment.

研究实施时间：

Study execute time：

从From 2024-09-13

至To      2026-09-13

征募观察对象时间：

Recruiting time：

从From 2024-09-13

至To      2026-09-13

干预措施：

Interventions：

组别：

宣肺通窍针法组

样本量：

30

Group：

Xuanlong Tongjiao Acupuncture Group

Sample size：

干预措施：

选穴：迎香、鼻通、印堂、风池、列缺、合谷、足三里、三阴交。操作：取仰卧位，常规消毒后，迎香穴针尖透向鼻通穴,得气后用强刺激手法运针 30s；鼻通穴针尖向内上方斜刺，针刺诸穴。

干预措施代码：

Intervention：

Selected points: Yingxiang nasal passage Yintang Fengchi Leshou Hegu Ashisanli Sanyinjiao. Operation: take the supine position after routine sterilization Yingxiang point needle tip through to the nose through the point after getting qi with a strong stimulation technique to transport the needle for 30s; nose through the point needle tip to the inner upper oblique stabbing needling all the points.

Intervention code：

组别：

蝶腭神经节刺法组

样本量：

30

Group：

Pterygopalatine ganglion spiking group

Sample size：

干预措施：

“押手”按压定点处皮肤，“刺手”沿“押手”指甲缘进针，针尖朝对侧太阳穴刺入，相当于定点位置的内上方，稍偏前。刺中即出针。术后用干棉球按压针眼 3min。

干预措施代码：

Intervention：

Pressing the skin at the fixed point, the “stabbing hand” enters the needle along the edge of the fingernail of the “betting hand”, and the tip of the needle stabs towards the opposite solar plexus, which is equivalent to the inner upper part of the fixed point position, slightly in front. The needle is discharged as soon as it is inserted. After the procedure, a dry cotton ball is used to press on the eye of the needle for 3 min.

Intervention code：

组别：

宣肺通窍针法结合蝶腭神经节刺法组

样本量：

30

Group：

Xuan Lung Tong Qiao acupuncture combined with pterygopalatine ganglion stabbing group

Sample size：

干预措施：

宣肺通窍针法、蝶腭神经节刺法取穴、针法及疗程同前。

干预措施代码：

Intervention：

Xuanlong Tongqiao Acupuncture and Pterygopalatine Ganglion Stabbing Acupuncture points, needling method and treatment course were the same as before.

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu Province

City：

单位(医院)：

江苏省中医院

单位级别：

三甲医院

Institution/hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Third-class

测量指标：

Outcomes：

指标中文名：

AR 症状评分表

指标类型：

主要指标

Outcome：

Allergic rhinitis Symptom Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

AR 的视觉评分量表(视觉模拟量表)

指标类型：

次要指标

Outcome：

Visual Analogue Scale，VAS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

鼻症状总分

指标类型：

次要指标

Outcome：

total nasal symptom score, TNSS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

鼻炎伴随症状总分

指标类型：

次要指标

Outcome：

total non-nasal symptom score，TNNSS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

AR 体征评分表

指标类型：

主要指标

Outcome：

Allergic rhinitis Signs and Symptoms Score Sheet

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

鼻结膜炎生命质量调查问卷

指标类型：

次要指标

Outcome：

Rhinoconjunctivitis Quality of Life Questionnaire，RQLQ

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血样标本

组织：

Sample Name：

blood specimen

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 65 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）：

随机数字表法随机选取 AR 患者，分组方法: 首先将90例患者从1开始编号到90(下表第一行);然后从随机数字表中的任一行任一列开始，如从第2行第5列开始，以此读取3位数作为一个随机数录入编号下面(下表第二行);再将全部选出的随机数从小到大进行编序号(随机数相同的按照先手顺序编号)，记录在第三行(下表);我们规定序号1~30为宣肺通窍针法组，序号31~60为蝶腭神经节刺法组，序号为61~90为宣肺通窍针法结合蝶腭神经节刺法组。

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

Random number table method to randomly select AR patients, grouping method: first of all, 90 patients from 1 to 90 (the first line of the table below); and then from the random number table of any line of any columns to start, such as from the second line of the fifth column to start, and this reads the 3-digit number as a random number recorded under the number (the second line of the table below); and then all the selected random numbers from small to large serial numbering (random number of the same In accordance with the first hand order numbering), recorded in the third line (the following table); we stipulate that the serial number 1 ~ 30 for the XuanLong TongXiao acupuncture group, serial number 31 ~ 60 for the pterygopalatine ganglion assassination group, the serial number for 61 ~ 90 for the XuanLong TongXiao acupuncture combined with the pterygopalatine ganglion assassination group.

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）：

本研究原始数据不公开共享

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

The original data of this study is not publicly available for sharing.

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：

数据采集，采用纸质版“AR 症状评分表、AR 体征评分表、鼻症状总分、鼻炎伴随症状总分、AR 的视觉评分量表(视觉模拟量表)、鼻结膜炎生命质量调查问卷”和电子病历系统（内网）相结合的模式。研究中所有研究对象资料及原始研究数据均保存于南京中医药大学附属医院江苏省中医院针灸康复科科研项目数据库。

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

For data collection a combination of paper-based "Allergic rhinitis Symptom Scale Allergic rhinitis Signs and Symptoms Score Sheet total nasal symptom score TNSS total non-nasal symptom scoreTNNSS Visual Analogue Scale VAS Rhinoconjunctivitis Quality of Life Questionnaire RQLQ" and electronic medical record system (intranet) was used. All the information of the research subjects and the original research data in the study were saved in the database of the scientific research program of the Department of Acupuncture and Rehabilitation Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated Hospital of Nanjing University of Traditional Chinese Medicine.

数据管理委员会：

Data Managemen Committee：

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