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“健脾疏肝”太乙温灸法治疗女性IBS-D患者的临床疗效观察及其临床推广研究

注册号：

Registration number：

ITMCTR2025000807

最近更新日期：

Date of Last Refreshed on：

2025-04-22

注册时间：

Date of Registration：

2025-04-22

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

“健脾疏肝”太乙温灸法治疗女性IBS-D患者的临床疗效观察及其临床推广研究

Public title：

Clinical Efficacy Observation and Promotion Study of Taiyi Warm Moxibustion Therapy for Strengthening the Spleen and Soothing the Liver in Female Patients with IBS-D

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“健脾疏肝”太乙温灸法治疗女性IBS-D患者的临床疗效观察及其临床推广研究

Scientific title：

Clinical Efficacy Observation and Promotion Study of Taiyi Warm Moxibustion Therapy for Strengthening the Spleen and Soothing the Liver in Female Patients with IBS-D

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：

张方

研究负责人：

张方

Applicant：

Fang Zhang

Study leader：

Fang Zhang

申请注册联系人电话：

Applicant telephone：

+86 189 1709 6361

研究负责人电话：

Study leader's telephone：

+86 18917096361

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：

869732219@qq.com

研究负责人电子邮件：

Study leader's E-mail：

869732219@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：

上海市徐汇区宛平南路650号

研究负责人通讯地址：

上海市徐汇区宛平南路650号

Applicant address：

650 Wanping Road South Xuhui District Shanghai

Study leader's address：

650 Wanping Road South Xuhui District Shanghai

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：

上海市针灸经络研究所

Applicant's institution：

Shanghai Research Institute of Acupuncture and Meridian

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：

2025-018

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：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/19 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Cong-quan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

110 Ganhe Road Hongkou District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6516 1782

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yyyyllwyh@163.com

研究实施负责（组长）单位：

上海市针灸经络研究所

Primary sponsor：

Shanghai Research Institute of Acupuncture and Meridian

研究实施负责（组长）单位地址：

上海市徐汇区宛平南路650号

Primary sponsor's address：

650 Wanping Road South Xuhui District Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市针灸经络研究所医疗门诊部

具体地址：

上海市徐汇区宛平南路650号

Institution
hospital：

Shanghai Research Institute of Acupuncture and Meridian Outpatient Department

Address：

650 Wanping Road South Xuhui District Shanghai

经费或物资来源：

上海市卫生健康委员会

Source(s) of funding：

Shanghai Municipal Health Commission

研究疾病：

腹泻型肠易激综合征

研究疾病代码：

Target disease：

Diarrheal irritable bowel syndrome

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：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

观察“健脾疏肝”太乙温灸法治疗女性IBS-D患者的疗效，筛选性别相关IBS-D患者的关键影像学标志和肠道微生物标志，探讨“健脾疏肝”太乙温灸法对女性IBS-D患者HPA轴功能和“肠-脑”交互的调节作用，为揭示“健脾疏肝”太乙温灸法治疗肠易激综合征的疗效和作用机制提供高质量证据。

Objectives of Study：

To observe the efficacy of Taiyi Warm Moxibustion Therapy for "Strengthening the Spleen and Soothing the Liver" in female patients with IBS-D screen key imaging and gut microbiota biomarkers related to gender-specific IBS-D and explore the regulatory effects of Taiyi Warm Moxibustion Therapy on HPA axis function and the "gut-brain" interaction in female IBS-D patients. This study aims to provide high-quality evidence for elucidating the therapeutic efficacy and mechanisms of Taiyi Warm Moxibustion Therapy in treating irritable bowel syndrome. Key Points of Translation:

药物成份或治疗方案详述：

“健脾疏肝”太乙温灸组干预 在基础干预的基础上给予艾灸治疗。选取中脘、双侧天枢、双侧上巨虚、双侧三阴交穴。穴位定位参照中华人民共和国国家标准《腧穴名称与定位》（GB/T 12346-2006）定位。受试者均取仰卧位，所有穴位常规消毒。将直径为3cm的精制艾条（南阳汉医艾绒有限公司）置灸架上点燃后距离穴位表面3-5cm施灸，运用微型红外测温仪（美国福禄公司，型号Fluke62）对温度进行监测，使穴位体表温度保持在43±1℃，每次每穴各灸30min，隔日1次，每周3次，连续治疗6周。 安慰温灸组干预 在基础干预的基础上给予艾灸治疗。选取中脘、双侧天枢、双侧上巨虚、双侧三阴交穴。穴位定位参照中华人民共和国国家标准《腧穴名称与定位》（GB/T 12346-2006）定位。受试者均取仰卧位，所有穴位常规消毒。将直径为3cm的精制艾条（南阳汉医艾绒有限公司）置灸架上点燃后距离穴位表面8-10cm施灸，运用微型红外测温仪（美国福禄公司，型号Fluke62）对温度进行监测，使穴位体表温度保持在37±1℃，每次每穴各灸30min，隔日1次，每周3次，连续治疗6周。

Description for medicine or protocol of treatment in detail：

Intervention of Taiyi Warm Moxibustion Therapy for "Strengthening the Spleen and Soothing the Liver" On the basis of standard care moxibustion therapy was administered. The acupoints selected included Zhongwan (CV12) bilateral Tianshu (ST25) bilateral Shangjuxu (ST37) and bilateral Sanyinjiao (SP6). The localization of acupoints was performed according to the National Standard of the People's Republic of China: Nomenclature and Location of Acupoints (GB/T 12346-2006). Participants were placed in a supine position and all acupoints were routinely disinfected. Refined moxa sticks (3 cm in diameter produced by Nanyang Hanyi Moxa Wool Co. Ltd.) were placed on a moxibustion stand ignited and applied 3-5 cm above the surface of the acupoints. A miniature infrared thermometer (Fluke 62 Fluke Corporation USA) was used to monitor the temperature ensuring that the surface temperature of the acupoints remained at 43±1°C. Each acupoint was treated for 30 minutes per session with sessions conducted every other day three times per week for a total of 6 consecutive weeks. Intervention of Sham Warm Moxibustion Group On the basis of standard care sham moxibustion therapy was administered. The acupoints selected included Zhongwan (CV12) bilateral Tianshu (ST25) bilateral Shangjuxu (ST37) and bilateral Sanyinjiao (SP6). The localization of acupoints was performed according to the National Standard of the People's Republic of China: Nomenclature and Location of Acupoints (GB/T 12346-2006). Participants were placed in a supine position and all acupoints were routinely disinfected. Refined moxa sticks (3 cm in diameter produced by Nanyang Hanyi Moxa Wool Co. Ltd.) were placed on a moxibustion stand ignited and applied 8-10 cm above the surface of the acupoints. A miniature infrared thermometer (Fluke 62 Fluke Corporation USA) was used to monitor the temperature ensuring that the surface temperature of the acupoints remained at 37±1°C. Each acupoint was treated for 30 minutes per session with sessions conducted every other day three times per week for a total of 6 consecutive weeks.

纳入标准：

女性IBS-D受试者纳入标准 （1）符合罗马Ⅳ和《2020年中国肠易激综合征专家共识意见》定义的IBS-D患者； （2）女性，18岁≤年龄≤49岁； （3）周腹痛评分≥3分（0-10分制）； （4）理解、同意参加本研究并签署知情同意书。 女性健康受试者纳入标准： （1）6个月内，受试者没有腹痛、腹胀、腹部不适、大便性状和频率改变； （2）女性，18岁≤年龄≤49岁； （3）理解、同意参加本研究并签署知情同意书。 男性IBS-D受试者纳入标准： （1）符合罗马Ⅳ和《2020年中国肠易激综合征专家共识意见》定义的IBS-D患者； （2）男性，18岁≤年龄≤49岁； （3）周腹痛评分≥3分（0-10分制）； （4）理解、同意参加本研究并签署知情同意书。

Inclusion criteria

Inclusion Criteria for Female IBS-D Participants (1)Meet the diagnostic criteria for IBS-D as defined by the Rome IV criteria and the 2020 Chinese Expert Consensus on Irritable Bowel Syndrome. (2)Female aged 18 to 49 years. (3)Weekly abdominal pain score ≥ 3 (on a 0-10 scale). (4)Understand and agree to participate in the study and sign the informed consent form. Inclusion Criteria for Healthy Female Participants (1)No abdominal pain bloating abdominal discomfort or changes in stool form and frequency in the past 6 months. (2)Female aged 18 to 49 years. (3)Understand and agree to participate in the study and sign the informed consent form. Inclusion Criteria for Male IBS-D Participants (1)Meet the diagnostic criteria for IBS-D as defined by the Rome IV criteria and the 2020 Chinese Expert Consensus on Irritable Bowel Syndrome. (2)Male aged 18 to 49 years. (3)Weekly abdominal pain score ≥ 3 (on a 0-10 scale). (4)Understand and agree to participate in the study and sign the informed consent form.

排除标准：

女性IBS-D受试者排除标准 （1）具有肠道器质性病变，或属于感染后IBS-D患者； （2）年龄>40岁，月经周期不规律超过6个月；或≤40岁，月经周期不规律超过1年；或合并妇科器质性病变的患者； （3）合并严重心、脑、肝、肾等疾病及恶性肿瘤的患者； （4）伴有精神类疾病患者，或者有中、重度焦虑抑郁的患者； （5）既往有胃肠道二级以上手术、消化道切除史的患者； （6）入组前2个月内使用治疗IBS-D药物的患者； （7）入组前1个月内参加过或正在参加其他临床试验者； （8）在本研究所选用的穴位区域存在皮肤病、肢体残缺等状况而无法施灸者； （9）既往具有温和灸治疗史的患者； （10）妊娠、哺乳期的患者； （11）近三个月有服用任何影响本研究所涉及检测指标的药物（如益生菌、乳酸菌饮品、止泻剂、胃肠动力药、抗生素、中药等）者。 女性健康受试者排除标准： （1）具有做脑神经影像禁忌症的受试者； （2）具有肠道器质性病变，或既往有胃肠道二级以上手术、消化道切除史的受试者； （3）年龄>40岁，月经周期不规律超过6个月；或≤40岁，月经周期不规律超过1年；子宫切除术后或双侧输卵管卵巢切除术后的患者；或合并妇科器质性病变的患者； （4）合并严重心、脑、肝、肾等疾病及恶性肿瘤的患者； （5）伴有精神类疾病患者，或者有中、重度焦虑抑郁的患者； （6）入组前1个月内参加过或正在参加其他临床试验者； （7）妊娠、哺乳期的受试者； （8）近三个月有服用任何影响本研究所涉及检测指标的食物（如益生菌、乳酸菌饮品、止泻剂、胃肠动力药、抗生素、中药等）者。 男性IBS-D受试者排除标准： （1）具有做脑神经影像禁忌症的患者； （2）具有肠道器质性病变，或属于感染后IBS-D患者； （3）合并严重心、脑、肝、肾等疾病及恶性肿瘤的患者； （4）伴有精神类疾病患者，或者有中、重度焦虑抑郁的患者； （5）既往有胃肠道二级以上手术、消化道切除史的患者； （6）入组前2个月内使用治疗IBS-D药物的患者； （7）入组前1个月内参加过或正在参加其他临床试验者； （8）近三个月有服用任何影响本研究所涉及检测指标的食物（如益生菌、乳酸菌饮品、止泻剂、胃肠动力药、抗生素、中药等）者。

Exclusion criteria：

Exclusion Criteria for Female IBS-D Participants (1)Presence of organic intestinal diseases or post-infectious IBS-D. (2)Age > 40 years with irregular menstrual cycles for over 6 months; or age ≤ 40 years with irregular menstrual cycles for over 1 year; or patients with gynecological organic diseases. (3)Patients with severe cardiovascular cerebrovascular hepatic renal diseases or malignant tumors. (4)Patients with psychiatric disorders or moderate to severe anxiety and depression. (5)Patients with a history of gastrointestinal surgery above grade 2 or gastrointestinal resection. (6)Patients who have used medications for IBS-D within 2 months prior to enrollment. (7)Patients who have participated in or are currently participating in other clinical trials within 1 month prior to enrollment. (8)Patients with skin diseases limb defects or other conditions in the acupoint areas selected for this study that prevent moxibustion treatment. (9)Patients with a history of warm moxibustion therapy. (10)Pregnant or lactating patients. (11)Patients who have taken any medications (e.g. probiotics lactic acid bacteria beverages antidiarrheals gastrointestinal motility drugs antibiotics traditional Chinese medicine etc.) that may affect the study's outcome measures within the past 3 months. Exclusion Criteria for Healthy Female Participants (1)Participants with contraindications for brain neuroimaging. (2)Participants with organic intestinal diseases or a history of gastrointestinal surgery above grade 2 or gastrointestinal resection. (3)Age > 40 years with irregular menstrual cycles for over 6 months; or age ≤ 40 years with irregular menstrual cycles for over 1 year; patients with a history of hysterectomy or bilateral salpingo-oophorectomy; or patients with gynecological organic diseases. (4)Participants with severe cardiovascular cerebrovascular hepatic renal diseases or malignant tumors. (5)Participants with psychiatric disorders or moderate to severe anxiety and depression. (6)Participants who have participated in or are currently participating in other clinical trials within 1 month prior to enrollment. (7)Pregnant or lactating participants. (8)Participants who have consumed any foods or medications (e.g. probiotics lactic acid bacteria beverages antidiarrheals gastrointestinal motility drugs antibiotics traditional Chinese medicine etc.) that may affect the study's outcome measures within the past 3 months. Exclusion Criteria for Male IBS-D Participants (1)Patients with contraindications for brain neuroimaging. (2)Patients with organic intestinal diseases or post-infectious IBS-D. (3)Patients with severe cardiovascular cerebrovascular hepatic renal diseases or malignant tumors. (4)Patients with psychiatric disorders or moderate to severe anxiety and depression. (5)Patients with a history of gastrointestinal surgery above grade 2 or gastrointestinal resection. (6)Patients who have used medications for IBS-D within 2 months prior to enrollment. (7)Patients who have participated in or are currently participating in other clinical trials within 1 month prior to enrollment. (8)Patients who have consumed any foods or medications (e.g. probiotics lactic acid bacteria beverages antidiarrheals gastrointestinal motility drugs antibiotics traditional Chinese medicine etc.) that may affect the study's outcome measures within the past 3 months.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2027-12-31

征募观察对象时间：

Recruiting time：

从From 2025-05-06

至To      2026-12-31

干预措施：

Interventions：

组别：

女性健康对照组

样本量：

10

Group：

Healthy Female Control Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

安慰温灸组

样本量：

32

Group：

Sham Warm Moxibustion Group

Sample size：

干预措施：

采用直径为3cm的精制艾条艾灸中脘、双侧天枢、双侧上巨虚、双侧三阴交穴，艾灸时艾条距离穴位表面8-10cm运用微型红外测温仪监测穴位体表温度，保持在37±1℃，每次每穴各灸30min，隔日1次，每周3次，连续治疗6周。

干预措施代码：

Intervention：

Refined 3-cm moxa sticks were used to apply moxibustion at Zhongwan (CV12), bilateral Tianshu (ST25), Shangjuxu (ST37), and Sanyinjiao (SP6). The sticks were held 8–10 cm above the skin, with temperature maintained at 37±1°C using infrared monitoring. Each point received 30 min of treatment per session, administered every other day (3×/week) for 6 weeks.

Intervention code：

组别：

男性IBS-D对照组

样本量：

10

Group：

Male IBS-D Control Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

太乙温灸组

样本量：

32

Group：

Taiyi Warm Moxibustion Group

Sample size：

干预措施：

采用直径为3cm的精制艾条艾灸中脘、双侧天枢、双侧上巨虚、双侧三阴交穴，艾灸时艾条距离穴位表面3-5cm运用微型红外测温仪监测穴位体表温度，保持在43±1℃，每次每穴各灸30min，隔日1次，每周3次，连续治疗6周。

干预措施代码：

Intervention：

Refined 3-cm moxa sticks were used to apply moxibustion at Zhongwan (CV12), bilateral Tianshu (ST25), Shangjuxu (ST37), and Sanyinjiao (SP6). The sticks were held 3–5 cm above the skin, with temperature maintained at 43±1°C using infrared monitoring. Each point received 30 min of treatment per session, administered every other day (3×/week) for 6 weeks.

Intervention code：

样本总量 Total sample size ： 84

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市针灸经络研究所医疗门诊部

单位级别：

无

Institution/hospital：

Shanghai Research Institute of Acupuncture and Meridian Outpatient Department

Level of the institution：

None

测量指标：

Outcomes：

指标中文名：

第12周的综合响应率

指标类型：

次要指标

Outcome：

Comprehensive Response Rate at Week 12 of Intervention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑神经影像测量

指标类型：

附加指标

Outcome：

Brain Neuroimaging Measurements

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

干预第6周的综合响应率

指标类型：

主要指标

Outcome：

Comprehensive Response Rate at Week 6 of Intervention

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

盲法评价

指标类型：

附加指标

Outcome：

Blinding Assessment

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

情绪状况评估（焦虑抑郁量表）

指标类型：

次要指标

Outcome：

Emotional status Assessment (Hospital Anxiety and Depress Scale)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

第3、6、9、12周综合响应率的重复测量比较

指标类型：

次要指标

Outcome：

Comparison of repeated measurements of comprehensive response rates at weeks 3 6 9 and 12

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性评估

指标类型：

次要指标

Outcome：

Safety Assessment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

IBS生活质量量表

指标类型：

次要指标

Outcome：

IBS quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肠道菌群物种组成及其丰度

指标类型：

附加指标

Outcome：

Gut Microbiota Composition and Abundance

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血清E2、CRH、ACTH、CORT浓度

指标类型：

附加指标

Outcome：

Serum concentrations of E2 CRH ACTH and CORT

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腹痛视觉模拟评分

指标类型：

次要指标

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

IBS症状严重度积分

指标类型：

次要指标

Outcome：

IBS symptom severity scale

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：

粪便

组织：

Sample Name：

Feces

Tissue：

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 49 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）：

由不参与临床试验的研究协调员采用SPSS24.0软件生成随机分组方案，并制作随机分配表密封保存。从随机数字表的第一个数字开始逐个将随机数字和分组信息密封于不透光的信封中，根据患者就诊的先后顺序向研究协调员获取相应的随机数字和分组信息来纳入受试者，试验严格按照随机化设计序列纳入患者，将符合纳入标准的女性IBS-D患者随机分为“健脾疏肝”太乙温灸组和安慰温灸组。受试者、检查人员、数据收集人员和统计人员均不了解分组情况，临床基地医师对分组情况知情。仅发生严重不良事件时，研究人员才能破盲采取措施。受试者对治疗方式的盲法评价将在第一次治疗后和最后一次治疗后通过填写期望值和信度评估量表进行。

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

The randomization scheme was generated by a research coordinator not involved in the clinical trial using SPSS 24.0 software and a randomization allocation table was created and sealed. Starting from the first number in the random number table each random number and corresponding group assignment were sealed in opaque envelopes. Based on the order of patient visits the research coordinator provided the corresponding random number and group assignment to enroll participants. The trial strictly adhered to the randomized design sequence and female IBS-D patients who met the inclusion criteria were randomly assigned to either the "Strengthening the Spleen and Soothing the Liver" Taiyi Warm Moxibustion Group or the Sham Moxibustion Group. Participants examiners data collectors and statisticians were blinded to the group assignments while the clinical site physicians were aware of the allocations. Unblinding was permitted only in the event of severe adverse events allowing researchers to take necessary measures. Participants' blinding effectiveness regarding the treatment method was evaluated by completing expectancy and credibility assessment scales after the first treatment and the final treatment.

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

数据管理委员会：

Data Managemen Committee：

无

No

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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