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Multicenter Real World Study of the Evaluation of Traditional Chinese Medicine in the Treatment of Ankylosing Spondylitis

注册号：

Registration number：

ITMCTR2200005889

最近更新日期：

Date of Last Refreshed on：

2022-04-20

注册时间：

Date of Registration：

2022-04-20

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中医药治疗强直性脊柱炎的多中心真实世界疗效评价研究

Public title：

Multicenter Real World Study of the Evaluation of Traditional Chinese Medicine in the Treatment of Ankylosing Spondylitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中国中医科学院科技创新工程

Scientific title：

China Academy of Chinese Medical Sciences Innovation Fund

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：

ChiCTR2200058934 ; ChiMCTR2200005889

申请注册联系人：

徐晓涵

研究负责人：

刘宏潇

Applicant：

Xu Xiaohan

Study leader：

Liu Hongxiao

申请注册联系人电话：

Applicant telephone：

15106985623

研究负责人电话：

Study leader's telephone：

13522368875

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：

xxh0527@126.com

研究负责人电子邮件：

Study leader's E-mail：

liuhongxiao_123@163.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：

北京市西城区北线阁5号中国中医科学院广安门医院

研究负责人通讯地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Applicant address：

China Academy of Chinese Medical Sciences Guanganmen Hospital, No. 5, North Line Pavilion, Xicheng District, Beijing , China.

Study leader's address：

China Academy of Chinese Medical Sciences Guanganmen Hospital, No. 5, North Line Pavilion, Xicheng District, Beijing, 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：

中国中医科学院广安门医院

Applicant's institution：

China Academy of Chinese Medical Sciences Guanganmen Hospital

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：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

中国中医科学院广安门医院

Primary sponsor：

China Academy of Chinese Medical Sciences Guanganmen Hospital

研究实施负责（组长）单位地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Primary sponsor's address：

China Academy of Chinese Medical Sciences Guanganmen Hospital, No. 5, North Line Pavilion, Xicheng District, Beijing , 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)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

具体地址：

北京市西城区北线阁5号中国中医科学院广安门医院

Institution
hospital：

China Academy of Chinese Medical Sciences Guanganmen Hospital

Address：

China Academy of Chinese Medical Sciences Guanganmen Hospital, No. 5, North Line Pavilion, Xicheng District, Beijing , China.

经费或物资来源：

中国中医科学院科技创新工程课题

Source(s) of funding：

Tecnology Innovation Program of the China Academy of Chinese Medical Sciences

研究疾病：

强直性脊柱炎

研究疾病代码：

Target disease：

Ankylosing spondylitis

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

队列研究

Cohort study

研究所处阶段：

Study phase：

其它

Others

研究目的：

开展基于真实世界的中医药治疗AS达标控制及干预脊柱椎角炎影像学进展的疗效评价，从疾病活动度和功能、影像学指标、理化指标、患者报告结局、生活质量评价、心理状态评估、卫生经济学等多维度评估中医药治疗AS临床疗效，为中国强直性脊柱炎患者的达标治疗指南的形成提供数据支持。

Objectives of Study：

To evaluate the efficacy of traditional Chinese medicine in the treatment of AS based on the real world, such as disease activity and function, imaging index, physicochemical index, patient report outcome, quality of life evaluation, mental state evaluation, health economics and other dimensions to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of AS, so as to provide data support for the formation of standard treatment guidelines for patients with ankylosing spondylitis in China.

药物成份或治疗方案详述：

基于AS患者登记数据库，采取前瞻性队列研究，根据临床治疗手段分类，设置仅使用中药者为中药组、生物制剂治疗为西药组、中药+生物制剂治疗为中西医结合组。 一、分组 1.中药组 本研究纳入治疗方案为：根据中医辨证予中药汤剂（200ml 口服 2/日）治疗连续6个月、以7天为宽限期者，设置洗脱期为3个月。 2.西药组 本研究纳入治疗方案为： ①TNF-α拮抗剂：40mg，皮下注射，1/2周，治疗连续6个月，以30天为宽限期者，设置洗脱期为3个月； 或 ②IL-17拮抗剂：150mg，皮下注射，分别在第0、1、2、3、4周注射，随后每四周注射一次，治疗连续6个月，以30天为宽限期者，设置洗脱期为3个月。 3.中西医结合组 本研究纳入治疗方案为：同时采用中药与生物制剂治疗，治疗连续6个月，以30天为宽限期者，设置洗脱期为3个月。 二、界定合并用药 本研究针对基础治疗方案为西药组的患者，使用中成药者视情况决定是否纳入；针对服用慢作用抗风湿药者不予纳入；针对血压、血糖、血脂控制良好，服用降压药、降糖药、降脂药者经指控小组评定后确定是否纳入。 三、匹配原则 采用倾向性评分法进行匹配，设定协变量为年龄、病程，利用计算机进行比例为1：1的不可回放模式匹配。 四、疗效评价方法 1. 观察指标 ①主要观察指标 ASDAS-CRP ②次要观察指标 Bath强直性脊柱炎病情活动指数（BASDAI）；Bath强直性脊柱炎功能指数（BASFI）；③Bath强直性脊柱炎测量学指数（BASMI）；ASAS健康指数（ASAS-HI）；抑郁-焦虑-压力患者情绪自评量表（DASS-21）；工作效率与活动影响调查问卷（WPAI-AS）；慢性疾病治疗功能-疲劳量表（FACIT-fatigue）；C反应蛋白（CRP）、血沉（ESR） 2. 疗效评价标准 ASDAS-CRP达标率；ASAS20、40、60、5/6应答率；中医证候临床疗效评价标准 3. 评价时点 第 0、4、12、24周为4个观察时点进行评价，时间窗为观察时点前后７天。 五、影像学评价方法 拟于治疗前后进行脊柱磁共振检查，进行影像学评价：①骨髓水肿：SPARCC评分；②脂肪沉积：脂肪沉积椎体计数评分（评价时点为第0、24周）。读片由两名放射科医生独立分析，病灶数量由研究者统计，评分结果由影像科医生进行复核无误。 六、数据管理和质量控制 ①研究虽涉及不同研究单位，但课题人员相对固定，信息采集人员均为风湿病科专科医师并接受过统一培训考核，以保证掌握正确的调查方法和科学的工作态度；严格按照临床信息采集工作手册的要求进行信息的采集和录入，数据准确、全面，以确保数据的完整性、真实性和准确性； ②真实世界数据符合临床实际，但混杂因素较多，在现有数据基础上借鉴临床流行病学理念和数理统计方法，如倾向性评分、Coox回归等，尽可能避免和消除混杂和偏倚因素，提高临床评价的客观性； ③临床研究中各个环节有明确的人员配备，分工协作，各司其职；对信息采集过程中出现的问题，及时向课题负责人和临床监查员反映，以协调解决； ④所有录入信息均由课题组主要研究人员进行核查确认后，方为有效。数据存储的服务器专机专用，设有密码，设立访问权限，并装有防病毒软件，防止数据丢失；定期对录入数据进行核对，避免遗漏信息，如遇疑问及时与研究人员、临床医师、患者联系解决。

Description for medicine or protocol of treatment in detail：

Based on the AS patients registration database, a prospective cohort study was adopted. According to the classification of clinical treatments, the group treated only with Chinese medicine as the Chinese medicine group, the group treated with biological agents as the Western medicine group, and the group treated with Chinese medicine+ biological agents as the combined Chinese and Western medicine group. ⅠGroups 1.The Chinese medicine group: The treatment regimen included in this study was: According to TCM syndrome differentiation treated by Chinesse medicine decoction (200ml oral 2 / day) for 6 months, with 7 days as the grace period, the elution period was set to 3 months. 2.The Western medicine group The treatment regimen included in this study was: ①TNF-alpha?antagonist: 40 mg, injected subcutaneously for once or twice a fortnight, for 6 consecutive months of treatment, with a set elution period of 3 months for those with a 30-day grace period; or ②IL-17a antagonist: 150 mg, injected subcutaneously at weeks 0, 1, 2, 3, and 4, followed by injections every four weeks, for 6 consecutive months of treatment, with a set elution period of 3 months for those with a 30-day grace period. 3. the combined Chinese and Western medicine group:The treatment regimen included in this study was: Simultaneous treatment with Chinese medicine decoction and biological agents was used for 6 consecutive months of treatment, with an elution period of 3 months set for those with a grace period of 30 days. Ⅱ Defining combined medications In this study, for the patients in the western medicine group, those who use proprietary Chinese medicine will be included depends on the circumstances, and those who take conventional synthetic disease-modifying anti-rheumatic drugs will not be included; in view of good control of blood pressure, blood sugar and blood lipids, those who take antihypertensive drugs, hypoglycemic drugs and lipid-lowering drugs are assessed by the accusation team to determine whether they are included or not. Ⅲ The matching principle The tendency scoring method was used for matching, the covariates were set as age and course of disease, and the computer was used for non-playback pattern matching with a proportion of 1:1. Ⅳ Therapeutic evaluation methods 1.Observation indicators ①Primary observation indicator:Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein（ASDAS-CRP） ②Secondary observation indicators Bath Ankylosing Spondylitis Disease activity Index (BASDAI) ; Bath Ankylosing Spondylitis functional Index (BASFI) ; Bath Ankylosing Spondylitis Metrological Index (BASMI) ; Assessment of Spondyloarthritis International Society-Health Index (ASAS-HI) ; depression-anxiety-stress patients emotional self-rating scale (DASS-21) ; Work Efficiency and Activity Impact Questionnaire（WPAI-AS）; Facit-fatigue Scale for treatment of Chronic Diseases（FACIT-fatigue）;C reactive protein (CRP); Erythrocyte sedimentation rate (ESR) 2.Evaluation standard of curative effect The rate of reaching ASDAS-CRP; ASAS20/40/60?response?rate; Clinical efficacy evaluation criteria of TCM syndromes.The evaluation time points were 0, 4, 12 and 24 weeks, and the time window was 7 days before and after the observation time point. Ⅴ Imaging evaluation Spinal magnetic resonance examination was performed before and after treatment, and imaging evaluation was carried out: ①bone marrow edema: SPARCC score; ②fat deposition: fat deposition vertebral body count score (evaluation time point was 0 and 24 weeks). The reading of the film was independently analyzed by two radiologists, the number of lesions was counted by the researchers, and the scoring results were checked correctly by the radiologist. Ⅵ Data management and quality control ①Although the study involves different research units, the subject personnel are relatively fixed, and the information collectors are all rheumatic specialists and have received unified training and assessment to ensure that they master correct investigation methods and scientific working attitude; to collect and input information strictly in accordance with the requirements of the clinical information collection manual, and the data are accurate and comprehensive, so as to ensure the integrity, authenticity and accuracy of the data. ②The data of real world study accord with the clinical reality, but there are many confounding factors. On the basis of the existing data, we can draw lessons from the clinical epidemiological concepts and mathematical statistical methods, such as tendency scoring, Cox regression, etc., so as to avoid and eliminate confounding and biased factors as far as possible, and improve the objectivity of clinical evaluation. ③Clear staffing for each link in the clinical study, with a division of labor and responsibilities; problems that arise during the information collection process are reflected to the subject leader and clinical monitor in a timely manner for coordinated resolution. ④All the input information will not be valid until it is verified and confirmed by the main researchers of the research group. The server dedicated to data storage is equipped with passwords, access rights, and anti-virus software to prevent data loss; check the input data regularly to avoid omitting information, and contact researchers, clinicians and patients in time if in doubt.

纳入标准：

① 符合强直性脊柱炎西医诊断标准的活动期患者(ASDAS-CRP≥1.3) ② 符合强直性脊柱炎中医证候诊断标准 ③ 年龄18~65岁； ④ 自愿参加临床研究并同意签署知情同意书者。

Inclusion criteria

① Patients in the active phase of ankylosing spondylitis (ASDAS-CRP≥1.3) who meet the Western diagnostic criteria ② Meet the diagnostic criteria of Chinese medicine evidence of ankylosing spondylitis ③ Age 18~65 years old. ④ Those who voluntarily participated in the clinical study and agreed to sign the informed consent form.

排除标准：

①进行AS手术/针灸治疗者； ②合并类风湿、干燥综合征等其他风湿免疫病者； ③疾病晚期脊柱强直，严重关节畸形患者； ④合并肿瘤、严重心、脑血管、肾脏病、肝肾功能不全等严重原发性疾病者； ⑤血压、血糖、血脂控制不良者。

Exclusion criteria：

①Those who underwent AS surgery/acupuncture treatment. ②Patients with other rheumatic immune diseases, such as rheumatoid Arthritis, sjogren syndrome et al. ③Patients with advanced disease spinal ankylosis, severe joint deformity. ④Patients with severe primary diseases such as combined tumor, severe cardiac, cerebrovascular, renal disease, liver and kidney insufficiency. ⑤Patients with poorly controlled blood pressure, blood glucose and blood lipids.

研究实施时间：

Study execute time：

从From 2021-10-01

至To      2024-10-01

征募观察对象时间：

Recruiting time：

从From 2022-04-27

至To      2024-10-01

干预措施：

Interventions：

样本总量 Total sample size ： 300

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

China Academy of Chinese Medical Sciences Guanganmen Hospital

Level of the institution：

Three-a grade

测量指标：

Outcomes：

指标中文名：

情绪自评量表

指标类型：

次要指标

Outcome：

depression-anxiety-stress patients emotional self-rating 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：

Bath强直性脊柱炎病情活动指数

指标类型：

次要指标

Outcome：

Bath Ankylosing Spondylitis Disease activity Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

工作效率与活动影响调查问卷

指标类型：

次要指标

Outcome：

Work Efficiency and Activity Impact Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Bath强直性脊柱炎功能指数

指标类型：

次要指标

Outcome：

Bath Ankylosing Spondylitis functional Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Bath强直性脊柱炎测量指数

指标类型：

次要指标

Outcome：

Bath Ankylosing Spondylitis Metrological Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

国际脊柱关节病协会评估-健康指数

指标类型：

次要指标

Outcome：

Assessment of Spondyloarthritis International Society-Health Index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

慢性疾病治疗功能-疲劳指数

指标类型：

次要指标

Outcome：

Facit-fatigue Scale for treatment of Chronic Diseases

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

强直性脊柱炎疾病活动评分-C反应蛋白指标

指标类型：

主要指标

Outcome：

Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein

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：

舌苔

组织：

Sample Name：

coated tongue

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 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）：

基于真实世界的观察性研究，无随机。

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

Observational study based on real world, no randomization.

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）：

不共享

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

No Shared

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+中国中医风湿病注册研究信息平台

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

CRF+Chinese medicine rheumatology registration research information platform

数据管理委员会：

Data Managemen Committee：

有

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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