艾灸调控腹型肥胖患者糖-脂代谢的临床研究

注册号:

Registration number:

ITMCTR2025001109

最近更新日期:

Date of Last Refreshed on:

2025-06-03

注册时间:

Date of Registration:

2025-06-03

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

艾灸调控腹型肥胖患者糖-脂代谢的临床研究

Public title:

Effect of Moxibustion on Glycometabolism and Lipometabolism in Abdominally Obese Patients: A Randomized Controlled Trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

艾灸调控腹型肥胖患者糖-脂代谢的临床研究

Scientific title:

Effect of Moxibustion on Glycometabolism and Lipometabolism in Abdominally Obese Patients: A Randomized Controlled Trial

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:

张英溶

研究负责人:

周仲瑜

Applicant:

Zhang Yingrong

Study leader:

Zhou Zhongyu

申请注册联系人电话:

Applicant telephone:

15027186694

研究负责人电话:

Study leader's telephone:

18672308659

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:

1176906801@qq.com

研究负责人电子邮件:

Study leader's E-mail:

2209447940@qq.cm

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:

湖北省武汉市武昌区昙华林特1号

研究负责人通讯地址:

湖北省武汉市武昌区昙华林特1号

Applicant address:

No. 1 Tanhualin Wuchang District Wuhan Hubei Province China

Study leader's address:

No. 1 Tanhualin Wuchang District Wuhan Hubei Province China

申请注册联系人邮政编码:

Applicant postcode:

430061

研究负责人邮政编码:

Study leader's postcode:

430061

申请人所在单位:

湖北中医药大学

Applicant's institution:

Hubei University of 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:

2025009

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:

湖北中医药大学

Name of the ethic committee:

Hubei University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2025/3/5 0:00:00

伦理委员会联系人:

孙媛

Contact Name of the ethic committee:

SUN YUAN

伦理委员会联系地址:

湖北省武汉市洪山区黄家湖西路16号

Contact Address of the ethic committee:

No. 16 Huangjiahu West Road Hongshan District Wuhan Hubei Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

027-68890066

伦理委员会联系人邮箱:

Contact email of the ethic committee:

2889@hbucm.edu.cn

研究实施负责(组长)单位:

湖北中医药大学

Primary sponsor:

Hubei University of Chinese Medicine

研究实施负责(组长)单位地址:

湖北省武汉市武昌区昙华林特1号

Primary sponsor's address:

No. 1 Tanhualin Wuchang District Wuhan Hubei 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei Province

City:

Wuhan

单位(医院):

湖北中医药大学第一临床学院

具体地址:

湖北省武汉市武昌区昙华林特1号

Institution
hospital:

Hubei University of Chinese Medicine

Address:

No. 1 Tanhualin Wuchang District Wuhan Hubei Province China

经费或物资来源:

湖北省中医药重点学科(针灸学)

Source(s) of funding:

Key Discipline of Traditional Chinese Medicine in Hubei Province (Acupuncture and Moxibustion)

研究疾病:

腹型肥胖

研究疾病代码:

Target disease:

Abdominal Obesity

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:

肥胖作为一种慢性、复杂性疾病,与心脑血管疾病、恶性肿瘤、慢性呼吸系统疾病和代谢性疾病等“四大慢病” 密切相关,对健康中国建设目标带来巨大挑战。腹型肥胖是指脂肪多度积累在躯干部及腹内,尤其是腹腔内脏脂肪蓄积过多,主要表现为腹部增大、腰围增加。腹型肥胖更具代谢危险性,大大增加了心脏血管性疾病和中风的危险性。肥胖已成为全球健康危机,影响了人们的生命质量并增加医疗负担。2020年,肥胖的经济负担占全球GDP的2.4%,预计到2035年将增至4.3万亿美元,接近全球GDP的3 %,2010年,中国肥胖的医疗费用估计为93亿美元,预计到2030年将达到610亿美元。 2024年卫健委等16部委联合印发《“体重管理年”活动实施方案》,强调中医药在体重管理中的关键作用,明确提出推广中医药适宜技术,并制定涵盖不同人群的肥胖防治指南。艾灸疗法为特色中医药适宜技术,可有效治疗肥胖,特别是针对脾虚湿阻型肥胖,艾灸临床疗效优于其他中医疗法。基于此,本研究旨在通过不同灸温干预,观察其对腹型肥胖患者肥胖相关指标、心理健康及糖脂代谢相关指标的影响,探索艾灸对腹型肥胖患者糖脂代谢机制的影响及远期疗效,为艾灸防治腹型肥胖提供高质量循证医学证据。

Objectives of Study:

Obesity as a chronic and complex disease is closely associated with the "four major non-communicable diseases" (NCDs) including cardiovascular and cerebrovascular diseases malignant tumors chronic respiratory diseases and metabolic disorders posing significant challenges to the goals of the Healthy China initiative. Abdominal obesity characterized by excessive fat accumulation in the trunk and abdominal cavityparticularly visceral fatprimarily manifests as increased abdominal size and waist circumference. This type of obesity carries higher metabolic risks and significantly elevates the likelihood of cardiovascular diseases and stroke. Obesity has become a global health crisis impairing quality of life and increasing healthcare burdens. In 2020 the economic cost of obesity accounted for 2.4% of global GDP with projections indicating a rise to 4.3trillion(nearly34.3trillion(nearly39.3 billion in 2010 and are expected to reach $61 billion by 2030. In 2024 China's National Health Commission and 15 other ministries jointly issued the "Year of Weight Management" Implementation Plan highlighting the crucial role of Traditional Chinese Medicine (TCM) in weight management. The policy specifically advocates for promoting appropriate TCM techniques and developing obesity prevention and treatment guidelines for diverse populations. As a characteristic TCM therapy moxibustion has demonstrated significant efficacy in obesity treatment particularly for spleen deficiency with dampness obstruction syndrome showing superior clinical outcomes compared to other TCM approaches. Building on this evidence our study aims to:Investigate the effects of different moxibustion temperatures on obesity-related parameters psychological health and glucose-lipid metabolism in abdominal obesity patients;Explore the mechanisms underlying moxibustion's regulation of glucose-lipid metabolism;Evaluate its long-term therapeutic effects.This research will provide high-quality evidence to support moxibustion as an evidence-based intervention for abdominal obesity management.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

腹型肥胖诊断标准: 腹型肥胖诊断标准:根据中华人民共和国国家卫生健康委员会《肥胖症诊疗指南(2024年版)》,腹型肥胖的诊断标准为: 男性腰围≥90cm,女性腰围≥85cm。 (1)符合以上诊断标准,被确诊为腹型肥胖; (2)年龄:18~65岁,性别不限; (3)自愿接受本次临床研究干预方法,并签订知情同意书者。 同时符合以上3条者方可纳入。

Inclusion criteria

Diagnostic Criteria for Abdominal Obesity According to the Guidelines for the Diagnosis and Treatment of Obesity (2024 Edition) issued by the National Health Commission of the People's Republic of China the diagnostic criteria for abdominal obesity are: Men: Waist circumference ≥90 cm Women: Waist circumference ≥85 cm Inclusion Criteria: (1)Meeting the above diagnostic criteria for abdominal obesity; (2)Aged 18–65 years (gender unrestricted); (3)Voluntarily participating in the clinical trial with signed informed consent. Those who meet the above three articles at the same time can only be included.

排除标准:

(1)有严重的内分泌疾病(如甲减、库欣综合征等); (2)有临床诊断为饮食失调的历史,比如贪食症,食欲过盛,厌食症等,在过去三个月内体重波动大于5Kg; (3)有手术减肥史; (4)过去3个月内参加过减肥的临床研究或正在采取药物、饮食或者运动干预方式等减肥者; (5)过去3个月服用了已知的对体重或食欲有影响的药物,比如减肥药、皮质类固醇类药物、抗抑郁类药物、安定类药物、非选择性全身抗组胺药、尼古丁代替品、降糖药物等; (6)严重未控制疾病者,如心血管疾病、肝脏、肾脏疾病、急性感染、晚期肿瘤; (7)研究者认为可能存在增加受试者危险性或干扰受试者参与本临床试验能力的任何医学情况、精神情况、认知损伤或智力迟钝; (8)妊娠期、哺乳期、更年期妇女;计划8周内怀孕的妇女; (9)治疗局部有皮肤破溃感染或有溃疡,或患有其它严重皮肤疾病; (10)对艾烟过敏者、瘢痕体质者; (11)阴虚火旺证、实热证患者; (12)患者正在参与其他的临床试验; (13)近3月内接受过艾灸治疗; (14)依从性差,治疗期间无法配合及坚持治疗者。 凡符合以上排除标准中任意一条的患者均不能纳入本试验。

Exclusion criteria:

(1)Severe endocrine disorders (e.g. hypothyroidism Cushings syndrome); (2)Clinically diagnosed eating disorders (e.g. bulimia nervosa hyperphagia anorexia nervosa) or weight fluctuation >5 kg within the past 3 months; (3)History of bariatric surgery; (4)Participation in other weight-loss clinical trials within 3 months or current use of drug/diet/exercise interventions for weight management; (5)Use of medications affecting weight/appetite within 3 months including:Anti-obesity drugsCorticosteroidsAntidepressantsBenzodiazepinesNon-selective systemic antihistaminesNicotine replacement therapyHypoglycemic agents; (6)Poorly controlled comorbidities:Cardiovascular diseasesHepatic/renal dysfunctionAcute infectionsAdvanced malignancies; (7)Any medical/psychiatric condition (e.gcognitive impairment intellectual disability) that may increase risks or compromise trial participation (per investigators judgment); (8)Pregnancy lactation menopause or planned pregnancy within 8 weeks; (9)Local skin lesions (ulcers infections or severe dermatological diseases) at treatment sites; (10)Allergy to moxa smoke or keloid predisposition; (11)TCM syndromes of yin deficiency with fire effulgence or excess heat; (12)Current enrollment in other clinical trials; (13)Moxibustion treatment within 3 months; (14)Poor compliance (inability to adhere to the protocol). Patients meeting any of the above criteria will be excluded.

研究实施时间:

Study execute time:

From 2025-03-05

To      2027-03-05

征募观察对象时间:

Recruiting time:

From 2025-06-30

To      2025-12-31

干预措施:

Interventions:

组别:

37℃艾灸+生活方式干预

样本量:

37

Group:

37°C Moxibustion + Lifestyle Intervention

Sample size:

干预措施:

选取中脘、神阙、双侧足三里穴进行温和灸治疗。取仰卧位,全身放松;采用温和灸法,将艾条一端点燃,对准应灸腧穴部位,距离皮肤8-10厘米熏烤,使局部感到温和而舒适的热感,无明显刺热或灼热感。以灸至皮肤红晕为度。采用温度器观测,局部温度达到37±1℃。局部覆盖无菌洞巾保暖。每次30min,每周3次。同时进行生活方式干预,进行饮食和运动指导。干预周期12周。

干预措施代码:

Intervention:

The patient assumes a supine position with full-body relaxation.A moxa stick is ignited at one end and held on Zhongwan (CV12),Shenque (CV8),Bilateral Zusanli (ST36),The ignited moxa stick is held 8-10 cm away from the skin smoked roast, the skin surface maintains?37±1°C.30 minutes,3 sessions per week,12 weeks totally;Personalized calorie and nutrient adjustments based on metabolic needs;Structured aerobic and resistance training programs.

Intervention code:

组别:

43℃艾灸+生活方式干预

样本量:

37

Group:

43°C Moxibustion + Lifestyle Intervention

Sample size:

干预措施:

选取中脘、神阙、双侧足三里穴进行温和灸治疗。取仰卧位,全身放松;采用温和灸法,将艾条一端点燃,对准应灸腧穴部位,距离皮肤2-3厘米熏烤,使局部热感明显,明显感受到温热甚至炙热的刺激,以灸至皮肤温热红晕,而又不烧伤皮肤为度,采用温度器观测,局部温度达到43±1℃。局部覆盖无菌洞巾保暖。每次30min,每周3次。同时进行生活方式干预,进行饮食和运动指导。干预周期12周。

干预措施代码:

Intervention:

The patient assumes a supine position with full-body relaxation.A moxa stick is ignited at one end and held on Zhongwan (CV12)Shenque (CV8)Bilateral Zusanli (ST36)The ignited moxa stick is held 2-3 cm away from the skin smoked roast the skin surface maintains?43±1°C.30 minutes3 sessions per week12 weeks totally;Personalized calorie and nutrient adjustments based on metabolic needs;Structured aerobic and resistance training programs.

Intervention code:

样本总量 Total sample size : 74

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei province

City:

Wuhan

单位(医院):

湖北省中医院

单位级别:

三甲医院

Institution/hospital:

HUBEI PROVINCIAL HOSPITAL OF TCM

Level of the institution:

Third-class hospital

测量指标:

Outcomes:

指标中文名:

体脂百分比(F%)

指标类型:

次要指标

Outcome:

Body Fat Percentage (F%)

Type:

Secondary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

采用Inbody770人体成分分析仪测量

Measure time point of outcome:

Week 0, Week 4, Week 8, Week 12, Week 18, Week 24

Measure method:

Inbody770 body composition analyzer is used to measure the F%.

指标中文名:

体重

指标类型:

次要指标

Outcome:

weight

Type:

Secondary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

采用Inbody770人体成分分析仪测量

Measure time point of outcome:

Week 0, Week 4, Week 8, Week 12, Week 18, Week 24

Measure method:

Inbody770 body composition analyzer is used to measure the weight.

指标中文名:

中国内脏肥胖指数

指标类型:

次要指标

Outcome:

Chinese visceral adiposity index,CVAI

Type:

Secondary indicator

测量时间点:

第0周、第12周

测量方法:

男性:CVAI= -267.93+0.68×年龄+0.03×BMI+4.00×WC+ 22.00×lg(TG)-16.32×HDL-C 女性:CVAI= -187.32+1.71×年龄+4.23×BMI+1.12×WC+39.76×lg(TG)−11.66 ×HDL-C

Measure time point of outcome:

Week 0, Week 12

Measure method:

male:CVAI= -267.93+0.68×age+0.03×BMI+4.00×WC+ 22.00×lg(TG)-16.32×HDL-C female:CVAI= -187.32+1.71×age+4.23×BMI+1.12×WC+39.76×lg(TG)−11.66 ×HDL-C

指标中文名:

贝克抑郁量表(BDI-II)

指标类型:

次要指标

Outcome:

Beck Depression Inventory-II 

Type:

Secondary indicator

测量时间点:

第0周、第12周、第24周。

测量方法:

该量表分值范围0-63分,共21个问题,分值越高,表明抑郁程度越严重。

Measure time point of outcome:

Week 0, Week 12,Week 24

Measure method:

The scale scores ranged from 0 to 63 points for 21 questions, and the higher the score, the greater the severity of depression.

指标中文名:

空腹血糖、空腹胰岛素、血脂四项

指标类型:

次要指标

Outcome:

Fasting Plasma Glucose (FPG), Fasting Insulin (FINS),Standard Lipid Panel

Type:

Secondary indicator

测量时间点:

第0周、第12周

测量方法:

早上8点至10点空腹条件下抽取肘静脉血10mL,采用全自动生化分析仪检测空腹血糖、胰岛素、血脂四项(总胆固醇、三酰甘油、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇)含量。

Measure time point of outcome:

Week 0, Week 12

Measure method:

From 8:00 am to 10:00 am, 10 mL of cubital venous blood is extracted, and the content of FPG,FINS and Standard Lipid Panel (total cholesterol, triacylglycerol, low density lipoprotein cholesterol and high density lipoprotein cholesterol) are detected by automatic biochemical analyzer.

指标中文名:

胰岛素抵抗指数

指标类型:

次要指标

Outcome:

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Type:

Secondary indicator

测量时间点:

第0周、第12周

测量方法:

空腹血糖×空腹胰岛素÷22.5。

Measure time point of outcome:

Week 0, Week 12

Measure method:

HOMA-IR=FPG ×FINS/22.5

指标中文名:

腰臀比

指标类型:

次要指标

Outcome:

Waist-to-hip ratio

Type:

Secondary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

腰臀比=腰围(cm)÷臀围(cm)

Measure time point of outcome:

Week 0, Week 4, Week 8, Week 12, Week 18, Week 24

Measure method:

Waist-to-hip ratio=Waist Circumference(cm)/Hip Circumference(cm)

指标中文名:

腰围

指标类型:

主要指标

Outcome:

Waist Circumference

Type:

Primary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

受试者平视正前方,两侧肩部放轻松,双手保持自然下垂,中立位站直,身体中轴线垂直水平面,双足分开30-40cm,在同一侧髂嵴上缘与第十二肋骨下缘连线中点区域,用最小刻度为1mm非弹性皮尺,水平环绕腹部1周,皮尺贴近裸露皮肤,松紧适度,待平静状态下呼气结束时测量腰围的数值,单位为cm,精确至小数点后两位。

Measure time point of outcome:

Week 0 Week 4 Week 8 Week 12 Week 18 Week 24

Measure method:

subjects straight in front on both sides of the shoulder both hands keep natural sagging neutral position stand straight body axis vertical horizontal plane feet separate 30-40cm on the same side of the iliac crest on the edge and the 12 rib connection midpoint area with a minimum scale of 1mm inelastic tape 1 week horizontal around the abdomen near the bare skin moderate tightness be calm at the end of the circumference measurement

指标中文名:

体质指数

指标类型:

次要指标

Outcome:

BMI

Type:

Secondary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

BMI(kg/m2)=体重(kg)÷身高(m2)

Measure time point of outcome:

Week 0, Week 4, Week 8, Week 12, Week 18, Week 24

Measure method:

BMI (kg/m2) = Body weight (kg) /Height (m2)

指标中文名:

腰高比

指标类型:

次要指标

Outcome:

waist-height ratio

Type:

Secondary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

腰高比=腰围(cm)÷身高(cm)。

Measure time point of outcome:

Week 0, Week 4, Week 8, Week 12, Week 18, Week 24

Measure method:

waist-height ratio=Waist Circumference(cm)/Height(cm)

指标中文名:

臀围

指标类型:

次要指标

Outcome:

Hip Circumference

Type:

Secondary indicator

测量时间点:

第0周、第4周、第8周、第12周、第18周、第24周。

测量方法:

将非弹性皮尺紧贴而不压迫皮肤,经过臀部最高点,围绕身体一周,即臀部的最大周径

Measure time point of outcome:

Week 0, Week 4, Week 8, Week 12, Week 18, Week 24

Measure method:

the inelastic tape stick close without pressing the skin, through the highest point of the buttocks, around the body, that is, the maximum circumference diameter of the buttocks.

指标中文名:

广泛性焦虑量表(GAD-7)

指标类型:

次要指标

Outcome:

Generalized Anxiety Disorder 7-item scale (GAD-7)

Type:

Secondary indicator

测量时间点:

第0周、第12周、第24周。

测量方法:

该量表分值范围0-21分,共7个问题,分值越高,表明焦虑程度越严重。

Measure time point of outcome:

Week 0, Week 12,Week 24

Measure method:

The scale score ranged from 0-21 points, a total of 7 questions, the higher the score, the more serious the anxiety.

采集人体标本:

Collecting sample(s)
from participants:

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
Min age years
最大 65
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):

研究人员用spss26.0生成随机数字表,将随机分组数字装进信封中,信封外观应一致及密封应良好,让符合腹型肥胖纳入标准的病人随机抽取信封,医生根据信封内的随机数字将病人纳入治疗组37例和对照组37例。

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

In spss26.0 the random numbers table is generated and the randomization numbers are put into the envelope. The envelope appearance should be consistent and well sealed so that the patients meeting the abdominal obesity inclusion criteria should randomly draw the envelopes and the doctor will include the patients in the treatment group 37 and 37 control group based on the random numbers in the envelope.

盲法:

由于针灸研究的特殊性,考虑到实际临床情况,无法做到对临床医生与受试者实施盲法。在所有分析完成之前,评估者与统计学家都对分配不知情。

Blinding:

Due to the particularity of moxibustion research considering the actual clinical situation it cannot be blind to clinicians and subjects. The evaluator and statistician were blinded to the allocation until all analyses were completed.

是否共享原始数据:

IPD sharing:

Yes

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):

论文公开发表

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

Publication of Research Papers

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:制作纸质版的CRF表用于患者相关试验数据的采集和管理,待试验完成后由统计分析负责人与主要研究者,根据临床试验方案共同制订统计分析计划书,在数据库锁定前定稿,并制定出供统计分析所用电子表格,根据纸质版CRF表中的数据填入电子数据表格。数据管理:数据收集填写人员需经专门培训,熟练掌握纸质版CRF表填写,纸质版CRF表数据填写人员和临床操作人员、电子数据录入人员及统计分析人员均严格独立区分,各项人员均不可重复交叉。

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

The paper version of the CRF table is used for the collection and management of patient related trial data. After the trial the principal investigator shall make the statistical analysis plan according to the clinical trial plan finalized before the database lock and make the spreadsheet for statistical analysis fill in the electronic data form in the data in the paper CRF form. Data collection and filling personnel shall be specially trained to master the paper CRF form. Data filling personnel in the paper CRF form shall be strictly and independently distinguished from clinical operators electronic data entry personnel and statistical analysis personnel and all personnel are not allowed to be repeated.

数据管理委员会:

Data Managemen Committee:

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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