Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Treatment of severe immune thrombocytopenia with hormone resistance by combination of traditional Chinese and Western Medicine

注册号：

Registration number：

ITMCTR2000003847

最近更新日期：

Date of Last Refreshed on：

2020-08-29

注册时间：

Date of Registration：

2020-08-29

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中西医结合分层治疗激素抵抗的重型免疫性血小板减少症

Public title：

Treatment of severe immune thrombocytopenia with hormone resistance by combination of traditional Chinese and Western Medicine

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中西医结合分层治疗激素抵抗的重型免疫性血小板减少症

Scientific title：

Treatment of severe immune thrombocytopenia with hormone resistance by combination of traditional Chinese and Western Medicine

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：

ChiCTR2000037645 ; ChiMCTR2000003847

申请注册联系人：

江雯雯

研究负责人：

江雯雯

Applicant：

Wenwen Jiang

Study leader：

Wenwen Jiang

申请注册联系人电话：

Applicant telephone：

+86 15000127167

研究负责人电话：

Study leader's telephone：

+86 15000127167

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：

2504866135@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2504866135@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：

上海市芷江中路274号

研究负责人通讯地址：

上海市芷江中路274号

Applicant address：

274 Middle Zhijiang Road, Jing'an District, Shanghai

Study leader's address：

274 Middle Zhijiang Road, Jing'an 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：

上海市中医医院

Applicant's institution：

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

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：

2020SHL-KYYS-175

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：

上海市中医医院

Name of the ethic committee：

The Ethic Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of TCM

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：

凌丽

Contact Name of the ethic committee：

Li Ling

伦理委员会联系地址：

芷江中路274号

Contact Address of the ethic committee：

274 Middle Zhijiang Road, Jing'an District, Shanghai

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：

上海市中医医院

Primary sponsor：

Shanghai Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

芷江中路274号

Primary sponsor's address：

274 Middle Zhijiang Road, Jing'an District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

上海市申康医院发展中心

Source(s) of funding：

Shanghai Shenkang Hospital Development Center

研究疾病：

免疫性血小板减少症

研究疾病代码：

Target disease：

Immune thrombocytopenia

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：

原发性免疫性血小板减少症（ITP）是一种自身免疫性出血性疾病，其发病与自身抗体介导血小板破坏过多与巨核系增殖成熟障碍相关。目前根据2016版成人ITP诊治的中国专家共识将激素作为一线治疗方案。激素治疗本病的近期有效率约为85%，但在减量或停药的过程中大部分患者出现复发，其有效率仅在15%以下。对于患者对糖皮质激素治疗反应不佳或短期内复发，这种现象称为激素抵抗。二线治疗药物包括TPO、艾曲波帕，但价格昂贵，且停药后病情反复。中医论治激素抵抗的重型ITP从瘀血气火立论，认为瘀即“自身抗体”，瘀久化火则血小板破坏过多，瘀久耗气伤阴则导致血小板生成不足，此与ITP免疫异常机制思想一致，相应方剂临床应用成熟且安全有效。 本研究依据中医气、血、火三个主要发病因素辨证立法方药，将激素抵抗的重型ITP患者中最常见的气阴两虚型患者为研究对象，采用中西医结合治疗，并与艾曲波帕及其加中医进行随机对照，评估疗效、免疫状况及生活质量，为建立气阴两虚型激素抵抗的重型ITP的临床优化诊疗方案，提高疗效，改善生存质量，以及探讨中医证型和免疫调节、骨髓增殖程度之间的相关性提供理论依据，为今后进一步中西医结合治疗建立基础。

Objectives of Study：

Primary immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease. Its pathogenesis is related to the excessive destruction of platelets mediated by autoantibodies and the disorder of megakaryocyte proliferation and maturation. At present, hormone is considered as the first-line treatment according to the consensus of Chinese experts on diagnosis and treatment of adult ITP in 2016. The short-term effective rate of hormone therapy is about 85%, but most patients relapse in the process of reducing or stopping the drug, and the effective rate is only less than 15%. For patients with poor response to glucocorticoid therapy or relapse in a short time, this phenomenon is called hormone resistance. The second-line treatment drugs include TPO and etrapopa, but the price is expensive, and the condition is repeated after withdrawal. Traditional Chinese medicine treats severe ITP of hormone resistance from the point of view of blood stasis, Qi and fire, and considers that blood stasis is "autoantibody". If blood stasis turns into fire for a long time, platelet damage will be excessive; if blood stasis consumes Qi and damages Yin, it will lead to insufficient platelet production. This is consistent with the abnormal immune mechanism of ITP, and the corresponding prescriptions are mature, safe and effective in clinical application. In this study, according to the three main pathogenic factors of Qi, blood and fire in TCM, the most common type of Qi and yin deficiency in patients with hormone resistance was selected as the research object. The patients were treated with integrated traditional Chinese and Western medicine, and were randomly compared with etrapopa and its plus traditional Chinese medicine. The curative effect, immune status and quality of life were evaluated Clinical optimization of diagnosis and treatment program, improve the curative effect, improve the quality of life, and explore the correlation between TCM Syndrome Types and immune regulation, bone marrow proliferation degree to provide a theoretical basis for further integrated treatment of traditional Chinese and Western medicine.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

（1）年龄18-80岁，男女不限。 （2）糖皮质激素治疗4周以上无效或难治ITP患者，符合《成人原发免疫性血小板减少症诊治的中国专家共识（修订版）》（2018年）诊断标准，且中医辨证属气阴两虚型。 （3）连续两次血小板检测（非同一天内检测）≤20×10^9/L。 （4）自愿签署知情同意书者。

Inclusion criteria

(1) Aged 18-80 years old male and female; (2) Patients with ITP who were treated with glucocorticoid for more than 4 weeks met the diagnostic standard of "Chinese expert consensus on diagnosis and treatment of adult primary immune thrombocytopenia (Revised Edition) (2018), and TCM syndrome differentiation belongs to Qi and yin deficiency type; (3) Two consecutive platelet tests (not detected in the same day) <= 20 x 10^9/L; (4) Those who voluntarily sign informed consent.

排除标准：

（1）虽符合西医诊断标准，但中医证候不是阴虚型者。 （2）有血栓病史者。 （3）HBV、HCV、HIV携带者或患者。 （4）过敏体质或对多种药物过敏者。 （5）妊娠或哺乳期妇女。 （6）有精神病史患者。 （7）怀疑或者确有酒精、药物滥用病史者。 （8）严重心肺肝肾功能异常。 （9）严重或难以控制的感染。 （10）近4周内服用其他中药者或参加其它临床试验者。 （11）研究者认为患者不宜参加本研究的任何其他情况。

Exclusion criteria：

(1) Although it meets the diagnostic criteria of Western medicine, TCM syndrome is not Yin deficiency type; (2) Patients with history of thrombosis; (3) HBV, HCV, HIV carriers or patients; (4) Allergic constitution or allergic to a variety of drugs; (5) Pregnant or lactating women; (6) Patients with a history of mental illness; (7) Suspected or confirmed history of alcohol and drug abuse; (8) Severe abnormal function of heart, lung, liver and kidney; (9) Severe or uncontrollable infection; (10) Those who took other traditional Chinese medicine or participated in other clinical trials in recent 4 weeks; (11) Any other circumstances in which the investigator believes that the patient should not participate in this study.

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2022-12-31

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      2022-08-31

干预措施：

Interventions：

组别：

试验组

样本量：

45

Group：

experimental group

Sample size：

干预措施：

三七升板汤（颗粒剂）+艾曲波帕

干预措施代码：

Intervention：

Sanqi Shenban Decoction+Etrapopa

Intervention code：

组别：

对照组

样本量：

45

Group：

control group

Sample size：

干预措施：

艾曲波帕

干预措施代码：

Intervention：

Etrapopa

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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市中医医院

单位级别：

三级甲等

Institution/hospital：

Shanghai Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

骨髓检查

指标类型：

主要指标

Outcome：

Bone marrow examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

外周血淋巴细胞CD19+，CD4+中P-gp的表达

指标类型：

次要指标

Outcome：

Expression of P-gp in CD19+, CD4+

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血常规

指标类型：

主要指标

Outcome：

routine blood test

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：

骨髓

组织：

Sample Name：

bone marrow

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：

正在进行

Recruiting

年龄范围：

最小 岁
Min age years
最大 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）：

SPSS

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

SPSS

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

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）：

6个月以后

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

after 6 months

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：

ResMan

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

ResMan

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):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above