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蜂针疗法治疗膝骨关节炎的应用与示范
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注册号：

Registration number：

 ChiCTR2300077507 

最近更新日期：

Date of Last Refreshed on：

 2024-06-03 09:43:34 

注册时间：

Date of Registration：

 2023-11-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

蜂针疗法治疗膝骨关节炎的应用与示范

Public title：

Application and Demonstration of Bee Needle Therapy in Treating Knee Osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

蜂针疗法治疗膝骨关节炎的应用与示范

Scientific title：

Application and Demonstration of Bee Needle Therapy in Treating Knee Osteoarthritis

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：

徐明 

研究负责人：

徐明 

Applicant：

Ming Xu 

Study leader：

Ming Xu 

申请注册联系人电话：

Applicant telephone：

 +86 155 1907 6960

研究负责人电话：

Study leader's
telephone：

+86 155 1907 6960

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：

 acupuncturegary@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

 acupuncturegary@outlook.com

申请单位网址(自愿提供)：

Applicant 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：

中国贵州省贵阳市云岩区贵医路28号

研究负责人通讯地址：

中国贵州省贵阳市云岩区贵医路28号

Applicant address：

28 Guiyi Road, Yunyan District, Guiyang, Guizhou, China

Study leader's address：

28 Guiyi Road, Yunyan District, Guiyang, Guizhou, 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：

贵州医科大学附属医院

Applicant's institution：

Affiliated Hospital of Guizhou Medical University

研究负责人所在单位：

贵州医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Guizhou Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2023122K

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

贵州医科大学附属医院医学科学伦理委员会

Name of the ethic committee：

Ethics Committee of the Affillated Hospital of Guizhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-25 00:00:00

伦理委员会联系人：

王艺明

Contact Name of the ethic committee：

Wang Yiming

伦理委员会联系地址：

中国贵州省贵阳市云岩区贵医路28号

Contact Address of the ethic committee：

28 Guiyi Road, Yunyan District, Guiyang, Guizhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 851 8675 2685

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

贵州医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guizhou Medical University

研究实施负责（组长）单位地址：

中国贵州省贵阳市云岩区贵医路28号

Primary sponsor's address：

28 Guiyi Road, Yunyan District, Guiyang, Guizhou, 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)：

贵州

市(区县)：

Country：

China

Province：

Guizhou

City：

单位(医院)：

贵州省科技厅

具体地址：

贵州省贵阳市南明区科学路16号

Institution
hospital：

The Science and Technology Department of Guizhou Province

Address：

16 Science Road, Nanming District, Guiyang, Guizhou, China

经费或物资来源：

贵州省科技厅

Source(s) of funding：

The Science and Technology Department of Guizhou Province

研究疾病：

膝关节骨性关节炎  

Target disease：

Knee Osteoarthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

明确贵州本地区膝骨性关节炎患者对蜂针散刺法治疗的接受度、治疗有效率和复发率，为后续大范围多中心的推广应用提供循证医学依据; 明确蜂针治疗在贵州地区的过敏发生率、过敏程度及症状，为进一步完善蜂针散刺法的临床诊疗提供临床数据支撑; 明确蜂针散刺法治疗膝骨性关节炎的临床疗效，为临床治疗膝骨性关节炎提供新思路、新方法。  

Objectives of Study：

To clarify the acceptability, effective rate and recurrence rate of bee-needle scattered needling treatment for patients with knee osteoarthritis in this area of Guizhou, and the evidence-based medical basis is provided for the follow-up large-scale multi-center promotion and application; The incidence, degree and symptoms of allergies treated with acupuncture in Guizhou provide clinical data support for further improving the clinical diagnosis and treatment of bee needling and scattered needling; clarify the clinical efficacy of bee needling and scattered needling in the treatment of knee osteoarthritis, and provide a basis for clinical treatment. To provide new ideas and methods for knee osteoarthritis.

药物成份或治疗方案详述：

器械准备 (1)镊子，碘伏，棉签； (2)对照组选用的针刺器具是规格为0.20mm×(20-40)mm的“华佗牌”针灸针。 (3)试验组选用蜜蜂品种：选用花溪区蜂场自有的养殖“中华蜜蜂”工蜂。 治疗前准备 在进行蜂针治疗之前，向患者详介蜂针疗法优势特点及必要的常识，并耐心而详尽地告知医治过程中可能会出现的情况及注意条目。 组方 试验组（取穴参考人民卫生出版社出版的《无痛蜂疗法》，患侧取穴） 主穴：阿是穴、鹤顶、内外膝眼， 配穴：寒痹(关节剧痛)加肾俞、腰阳关，热痹(关节红肿疼痛)加曲池、大椎，行痹(关节游走性 疼痛)加膈俞，湿痹(关节酸胀疼痛)加足三里、阴陵泉。 操作：（来源于国家中医药管理局《中医适宜技术推广项目》中医蜂疗技术协作组） 蜂针治疗前，需先进行皮试，咨询并详细记录患者是否有相关过敏史。 皮试方法：病人卧位或坐位，取“外关穴”为皮试部位，常规穴位消毒，以左手拇、食指夹取蜜蜂腰身，并抓紧腹部，用点刺法点刺皮试部位。20mins后观察蛰刺点，若患者本身无明显不适，且红肿面直径＜5cm 的为阴性，可接受蜂针治疗；如有眩晕、胀痛难忍等不适，或皮试红肿面直径≥5cm 的为阳性，需停止治疗，为脱落病例。该组患者的治疗穴位尽量遵循隔次使用原则，上次治疗接受蛰刺的穴位尽量隔次再接受蛰刺治疗。 操作手法：患者舒适体位，充分暴露施针部位。以安尔碘棉球常规消毒。在擦拭时，从穴位的中心点向四周环绕擦拭。消毒后，切记不要再接触其他物品，以免污染。而后医生的双手亦应进行消毒。蜂疗前，术者右手持镊，左手摇晃蜂疗盒 5 次，使紧张的蜜蜂晕眩以利于取蜂，再用镊子伸进蜂盒夹取蜜蜂（注：蜂针用蜂取18日左右龄后工蜂即蜂群中的“采集蜂”）的胸部，注意夹取力度，防止夹断蜜蜂或使蜜蜂挣脱，从蜂疗盒中抓取蜜蜂后，用镊子在蜜蜂尾针上剐蹭3下，以进一步减毒。然后将蜜蜂交到术者的左手，以食指和拇指抓住蜜蜂的胸部，然后将蜜蜂移近穴位，使尾部螫针对准穴位刺入患者皮肤，即点即出，右手持镊将尾针快速拔出，不留针。 疗程：隔2天1次，每周2次，4次2周为一疗程，共医治1个疗程。 对照组（参照中国中医药出版社出版的《针灸治疗学》教材第九版） 主穴：阿是穴、血海、梁丘、膝眼、阳陵泉； 配穴：寒痹(关节剧痛)加肾俞、腰阳关，热痹(关节红肿疼痛)加曲池、大椎，行痹(关节游走性 疼痛)加膈俞，湿痹(关节酸胀疼痛)加足三里、阴陵泉。 操作：（参照全国中医药行业高等教育“十二五”规划教材《针灸治疗学》（第九版）:嘱患者舒适坐位或仰卧体位，以一次性针灸针，按处方穴位次序，进行标准操作，刺入得气后，行平补平泻法，留针30min。 疗程：每天1次，连续5次后，暂停2天，再继续治疗，10次2周为一个疗程，共1个疗程。 

Description for medicine or protocol of treatment in detail：

Instrument preparation (1) Tweezers, povidone-iodine, cotton swabs; (2) The acupuncture instrument used in the control group was "Huatuo brand" acupuncture needles with a specification of 0.20 mm × (20-40) mm. (3) The bee species selected for the test group: the "Chinese Apis" worker bees owned by the Huaxi District Bee Farm were selected. Preparation before treatment Before performing bee acupuncture treatment, the advantages and characteristics of bee acupuncture therapy and necessary common sense are introduced to the patient in detail, and the possible situations and precautions during the treatment process are patiently and thoroughly informed. Formulation Experimental group (for acupoint selection, refer to "Painless Bee Therapy" published by People's Medical Publishing House, for acupoint selection on the affected side) Main points: Ashi point, Heding, inner and outer knee eyes, Acupoints: Cold Bi (severe joint pain) plus Shenshu and Yaoyangguan, Hot Bi (joint redness, swelling and pain) plus Quchi and Dazhui, Xing Bi (joint migratory pain) plus Geshu, Shibi (joint soreness and swelling) Pain) Add Zusanli and Yinlingquan. Operation: (from the Traditional Chinese Medicine Apitherapy Technology Collaboration Group of the State Administration of Traditional Chinese Medicine’s "Traditional Chinese Medicine Appropriate Technology Promotion Project") Before bee acupuncture treatment, a skin test must be performed, and the patient must be consulted and recorded in detail whether he or she has a history of related allergies. Skin test method: With the patient in a supine or sitting position, take the "Waiguan point" as the skin test site, and disinfect the acupoint regularly. Use the thumb and index finger of your left hand to pinch the waist of the bee, hold the abdomen, and use pricking to prick the skin test site. Observe the sting point after 20 minutes. If the patient has no obvious discomfort and the red and swollen surface is less than 5cm in diameter, it is negative and can be treated with bee acupuncture. If there is dizziness, unbearable swelling and pain and other discomforts, or the red and swollen surface is ≥5cm in diameter by skin test If it is positive, treatment needs to be stopped, which is a dropout case. The treatment acupoints of this group of patients should follow the principle of alternate use as much as possible. The acupoints that were stung in the last treatment should be stung again as much as possible. Operating techniques: The patient should be in a comfortable position and the acupuncture site should be fully exposed. Routine disinfection with amiodine cotton balls. When wiping, wipe from the center of the acupuncture point to all sides. After disinfection, remember not to touch other items to avoid contamination. The doctor's hands should then be disinfected. Before apitherapy, the operator holds the tweezers in his right hand and shakes the apitherapy box 5 times with his left hand to stun the nervous bees to facilitate the removal of bees. Then he uses the tweezers to reach into the bee box and pick up the bees (note: it takes about 18 days for the bee stingers to be taken) The chest of the instar worker bee (the "gatherer bee" in the bee colony), pay attention to the clamping strength to prevent the bee from being pinched or causing the bee to break free. After grabbing the bee from the apitherapy box, use tweezers to scratch the bee's tail needle three times. , to further reduce the toxicity. Then hand the bee to the operator's left hand, grasp the bee's chest with the index finger and thumb, and then move the bee closer to the acupuncture point, so that the tail stinger is aimed at the acupuncture point and penetrates the patient's skin, and it comes out immediately. Hold the tweezers in your right hand and quickly remove the tail needle. Pull it out, leaving no needle. Course of treatment: once every 2 days, twice a week, 4 times every 2 weeks as one course of treatment, for a total of 1 course of treatment. Control group (refer to the ninth edition of the textbook "Acupuncture Therapeutics" published by China Traditional Chinese Medicine Press) Main points: Ashi point, Xuehai, Liangqiu, Kneeyan, Yanglingquan; Acupoints: Cold Bi (severe joint pain) plus Shenshu and Yaoyangguan, Hot Bi (joint redness, swelling and pain) plus Quchi and Dazhui, Xing Bi (joint migratory pain) plus Geshu, Shibi (joint soreness and swelling) Pain) Add Zusanli and Yinlingquan. Operation: (Refer to the "Twelfth Five-Year Plan" textbook for higher education in the Chinese medicine industry "Acupuncture Therapeutics" (ninth edition): Instruct the patient to sit comfortably or supine, use disposable acupuncture needles, and perform standard operations in the order of prescribed acupoints. , after piercing to gain qi, perform the flat tonic and flat diarrhea method, leaving the needle for 30 minutes. Course of treatment: once a day, after 5 consecutive times, pause for 2 days, and then continue treatment, 10 times for 2 weeks is a course of treatment, a total of 1 course of treatment. 

纳入标准：

Inclusion criteria

排除标准：

1.有食物、药物及接触过敏史者，蜂毒皮肤敏试验阳性或蜂毒过敏原检测阳性者； 2.对蜂针治疗畏惧者； 3.合并脏器衰竭者(如肝、肾功能检验检查结果严重异常者)； 4.合并有风湿、类风湿性关节炎者； 5.膝关节先天发育不良者； 6.妊娠期及哺乳期妇女； 7.观察期内接受关节镜治疗、关节置换等手术治疗者； 8.在观察期内因各种原因导致失防者。

Exclusion criteria：

1. People with a history of food, drug and contact allergies, positive skin sensitivity test of bee venom or positive test of bee venom allergen; 2. People who are afraid of bee needle treatment; 3. Patients with organ failure (such as those with seriously abnormal results of liver and kidney function tests); 4. Patients with rheumatism and rheumatoid arthritis; 5. Those with congenital dysplasia of the knee joint; 6. Pregnant and lactating women; 7. Those who received arthroscopic treatment, joint replacement and other surgical treatment during the observation period; 8. Those who lost their defense due to various reasons during the observation period.

研究实施时间：

Study execute time：

从 From 2023-04-01 00:00:00至 To 2024-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-11-23 00:00:00 至 To 2024-01-23 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 47

Group：

test group

Sample size：

干预措施：

蜂针疗法治疗

干预措施代码：

Intervention：

bee acupuncture treatment

Intervention code：

组别：

对照组

样本量：

 47

Group：

control group

Sample size：

干预措施：

针刺治疗

干预措施代码：

Intervention：

acupuncture treatment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州省 

市(区县)：

  

Country：

China

Province：

Guizhou

City：

单位(医院)：

 贵州医科大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Guizhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Lequesne 指数

指标类型：

主要指标

Outcome：

Lequesne index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

HSS 评分

指标类型：

主要指标

Outcome：

HSS score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

VAS 量表评分

指标类型：

次要指标

Outcome：

VAS scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

膝关节滑液IL-6

指标类型：

主要指标

Outcome：

IL-6 in synovial fluid of knee joint

Type：

Primary 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：

膝关节腔滑液

组织：

Sample Name：

synovial fluid of knee joint

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由课题组护士采取完全随机化方法分组，分为试验组、对照组，两组以 1:1 的对等比例进行分组。根据拟定的样本含量，利用统计软件包做出随机分拨的结果，并将结果以随机卡片的形式进行制作，密封于信封之内，并对信封进行序号标记。符合要求的病例投入该研究时，依接诊次序拆开信封，按照提示进行分组。

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

The nurses in the research group adopted a completely randomized method and divided them into the experimental group and the control group, and the two groups were grouped in an equal ratio of 1:1. According to the proposed sample content, use statistical software package to make the results of random allocation, and make the results in the form of random cards, seal them in envelopes, and mark the envelopes with serial numbers. When eligible cases were put into the study, the envelopes were opened according to the order of admission, and grouped according to the prompts.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

单盲（对评估及数据分析的人员设盲）。

Blinding：

Single-blind (the person doing the evaluation and data analysis is blinded).

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）：

无

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

none

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：

数据采集和管理均有课题组数据采集员进行，并由课题组内部护士整理汇总及原始数据保管。

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

The data collection and management are carried out by the data collectors of the research group, and the internal nurses of the research group organize and summarize and keep the original data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-11-10 14:42:26
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