今天是:2020-08-11 星期二

评价血必净注射液对重症肺炎疗效的随机、对照、多中心临床试验
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-13003534 

最近更新日期:

Date of Last Refreshed on:

2018-06-16 

注册时间:

Date of Registration:

2013-06-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价血必净注射液对重症肺炎疗效的随机、对照、多中心临床试验 

Public title:

Efficacy evaluation of Xuebijing injection on severe pneumonia: a randomized controlled multi-center clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价血必净注射液对重症肺炎疗效的随机、安慰剂平行对照、多中心临床试验 

Scientific title:

Efficacy evaluation of Xuebijing injection on severe pneumonia: a randomized placebo-controlled multi-center clinical trial 

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:

宋元林 

研究负责人:

白春学 

Applicant:

Song Yuanlin 

Study leader:

Bai Chunxue 

申请注册联系人电话:

Applicant telephone:

+86 15021757762 

研究负责人电话:

Study leader's telephone:

+86 18621170011 

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:

ylsong70@163.com 

研究负责人电子邮件:

Study leader's E-mail:

bai.chunxue@zs-hospital.sh.cn 

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:

上海市徐汇区枫林路180号 

研究负责人通讯地址:

上海市徐汇区枫林路180号 

Applicant address:

180 Fenglin Road, Xuhui District, Shanghai, China 

Study leader's address:

180 Fenglin Road, Xuhui District, Shanghai, 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:

复旦大学附属中山医院 

Applicant's institution:

Zhongshan Hospital, Fudan 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:

2011-38(3) 

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:

复旦大学附属中山医院伦理委员会 

Name of the ethic committee:

Zhongshan Hospital, Fudan University Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-06-24 

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:

复旦大学附属中山医院 

Primary sponsor:

Zhongshan Hospital Fudan Unversity 

研究实施负责(组长)单位地址:

上海市徐汇区枫林路180号 

Primary sponsor's address:

180 Fenglin Road, Xuhui District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

天津市科学技术委员会 

Source(s) of funding:

Tianjin Science and Technology committee 

研究疾病:

重症社区获得性肺炎 

Target disease:

Severe Community Acquired Pneumonia 

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:

上市后药物 

Study phase:

研究目的:

评价血必净注射液治疗重症社区获得性肺炎的有效性 

Objectives of Study:

To evaluate the efficacy of Xuebijing injection in the treatment of severe community acquired pneumonia. 

药物成份或治疗方案详述:

试验组和对照组分别在常规治疗基础上给予血必净注射液100ml+0.9%氯化钠注射液100ml,q12h,或0.9%氯化钠注射液200ml,q12h 

Description for medicine or protocol of treatment in detail:

The experimental group and the control group were given Xuebijing injection 100ml+ 0.9% saline injection 100ml, q12h or 0.9% saline injection 200ml, q12h plus a standard therapy 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)签署知情同意书; 2)年龄18-75周岁; 3)体重≥40kg且≤100kg; 4)入院时或入院不超过48小时,出现社区获得性肺炎的临床症状,符合重症社区获得性肺炎诊断标准(依据美国胸科学会定义),符合下列标准中的三项或三项以上:PaO2/FiO2 ≤250;呼吸频率 ≥ 30次/分;尿素氮>20mg/dl;感染致白细胞减少(白细胞计数<4000/mm3);血小板减少(血小板计数<100,000/mm3);低体温(体温<36℃);意识模糊,定向力障碍;低血压需要积极的液体复苏;符合社区获得性肺炎诊断的新出现肺部浸润的X线表现。住ICU的重症肺炎患者符合以下标准其中任何一项也可纳入:需要机械通气;感染性休克需要血管活性药升压治疗。 

Inclusion criteria

Provide signed informed consent, aged 18 to 75 years, weight ≥40 kg and ≤100 kg, clinical symptoms suggestive of community-acquired pneumonia, acquired outside of the hospital or less than 48 hours after hospital admission, met SCAP criteria (defined by the American Thoracic Society) fulfilled three or more of the following criteria: PaO2/FiO2 ratio ≤250 mmHg, respiratory rate ≥30 breaths/min, blood urea nitrogen (BUN) >20 mg/dL, leukopenia (white blood cell count (WBC) <4000 cells/ mm3) not due to other causes, thrombocytopenia (platelet count<100,000 cells/mm3), hypothermia (core temperature <36 degree C), new onset mental confusion, receiving treatment with vasopressors at therapeutic doses after adequate fluid resuscitation, or radiographic findings on new pulmonary infiltrate(s) consistent with CAP diagnosis. Patients with pneumonia of sufficient severity requiring ICU management and patients meeting at least one of the severity criteria, such as receiving mechanical ventilatory support or septic shock with the need for vasopressors, were also included in the study) 

排除标准:

1)患者预期寿命≤48小时;2)孕妇、哺乳期妇女;3)严重原发性疾病;4)使用免疫抑制剂和/或细胞毒性药物;5)肺部肿瘤致阻塞性肺炎;6)精神病患者;7)过敏体质者(≥两种物质过敏);8)30天内参加过其他临床试验者;9)近7天内使用过禁用药物者;10)明确诊断为严重ARDS者(多肺叶浸润,氧合指数<100mmHg);研究者判断不能完成试验者。 

Exclusion criteria:

Life expectancy was 48 hours or less, pregnant or lactating, diagnosed with severe primary diseases, using immunosuppressants and/or cytotoxic drugs, diagnosed with lung disease induced by obstructive lung tumors, diagnosed with psychiatric disorders, or if allergic to two or more substances. Further exclusion criteria included concurrently participating in other clinical trials within 30 days before enrollment, use of prohibited medicine within 7 days before enrollment, and a diagnosis of severe acute respiratory distress syndrome (ARDS) (if patient had multi-lobar infiltrates, a low PaO2/FiO2 ratio (<100 mmHg) and met the definition of severe ARDS, he/she was excluded), could not complete the study judged by investigators. 

研究实施时间:

Study execute time:

From2013-09-01To 2016-06-30 

征募观察对象时间:

Recruiting time:

From2013-09-01To 2016-06-30 

干预措施:

Interventions:

组别:

对照组

样本量:

350

Group:

Control group

Sample size:

干预措施:

0.9%氯化钠注射液200ml

干预措施代码:

Intervention:

0.9%NaCl 200 ml

Intervention code:

组别:

试验组

样本量:

350

Group:

Experimental group

Sample size:

干预措施:

血必净注射液100ml+0.9%氯化钠注射液100ml

干预措施代码:

Intervention:

Xuebijing 100ml+0.9%NaCl 100ml

Intervention code:

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):

复旦大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan Hospital, Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国医学科学院北京协和医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学齐鲁医院 

单位级别:

三级甲等 

Institution
hospital:

Qilu Hospital Shandong University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

第二军医大学附属长海医院 

单位级别:

三级甲等 

Institution
hospital:

Second Military Medical University, Changhai Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学总医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Medical University General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国人民解放军沈阳军区总医院 

单位级别:

三级甲等 

Institution
hospital:

Peoples Liberation Army General Hospital of Shenyang Military Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

The Fourth Affiliated Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北医科大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Hebei Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军空军总医院 

单位级别:

三级甲等 

Institution
hospital:

Peoples Liberation Army Air Force General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军第二炮兵总医院 

单位级别:

三级甲等 

Institution
hospital:

PLA Second Artillery General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

Renmin Hospital of Wuhan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学中南医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongnan Hospital of Wuhan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

中国人民解放军广州军区武汉总医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan General Hospital of Guangzhou Military Region, Peoples Liberation Army  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

郑州大学洛阳中心医院 

单位级别:

三级甲等 

Institution
hospital:

Luoyang Central Hospital Affiliated to Zhengzhou University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

烟台毓璜顶医院 

单位级别:

三级甲等 

Institution
hospital:

Yantai Yuhuangding Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

十堰太和医院 

单位级别:

三级甲等 

Institution
hospital:

Shiyan Taihe Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京世纪坛医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Shijitan Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军北京军区总医院 

单位级别:

三级甲等 

Institution
hospital:

PLA Beijing Military General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属新华医院 

单位级别:

三级甲等 

Institution
hospital:

Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

大连医科大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Dalian Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲医院 

Institution
hospital:

Chinese People's Liberation Army General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Chinese People’s Liberation Army General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

广州军区武汉总医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan General Hospital of Guangzhou Military Region  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

吉林大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Hospital Of Jilin University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湖南省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Hunan Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

第四军医大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

First Affiliated Hospital of Fourth Military Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

云南省第一人民医院 

单位级别:

三甲医院 

Institution
hospital:

First People's Hospital of Yunnan Province  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

沈阳医学院附属中心医院 

单位级别:

三甲医院 

Institution
hospital:

Central Hospital Affiliated to Shenyang Medical College  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽医科大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Anhui Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肺部感染严重指数风险评级改善

指标类型:

主要指标 

Outcome:

pneumonia severity index (PSI) improvement rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天死亡率

指标类型:

次要指标 

Outcome:

28-day mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气时间

指标类型:

次要指标 

Outcome:

The time of mechanical ventilation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住ICU时间

指标类型:

次要指标 

Outcome:

Total duration of ICU stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PSI评分

指标类型:

次要指标 

Outcome:

PSI 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:

SOFA评分

指标类型:

次要指标 

Outcome:

Sequential Organ Failure Assessment 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:

SOFA高风险比率

指标类型:

次要指标 

Outcome:

Sequential Organ Failure Assessment high risk Rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

APACHEII评分

指标类型:

次要指标 

Outcome:

APACHEII 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:

APACHEII评分改善率

指标类型:

次要指标 

Outcome:

APACHE II improvement Rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SIRS改善率

指标类型:

次要指标 

Outcome:

SIRS improvement Rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺损伤评分

指标类型:

次要指标 

Outcome:

Lung Injury 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:

肺损伤评分改善率

指标类型:

次要指标 

Outcome:

Lung Injury Score improvement Rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MODS评分

指标类型:

次要指标 

Outcome:

MODS 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:

MODS评分改善率

指标类型:

副作用指标 

Outcome:

MODS score improvement Rate

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

副作用指标 

Outcome:

Body temperature

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

副作用指标 

Outcome:

Oxygenation index

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

降钙素原

指标类型:

副作用指标 

Outcome:

Procalcitonin

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

副作用指标 

Outcome:

C-reactive protein

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D二聚体

指标类型:

副作用指标 

Outcome:

D-dimer

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗生素使用时间

指标类型:

副作用指标 

Outcome:

Total duration of antibiotic use

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部X线变化

指标类型:

副作用指标 

Outcome:

Chest x-ray changes

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

有创机械通气与无创机械通气的相互转化率

指标类型:

副作用指标 

Outcome:

The mutual conversion rates of invasive mechanical ventilation and noninvasive mechanical ventilation

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

副作用指标 

Outcome:

Total duration of hospitalization

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细菌培养转阴时间

指标类型:

次要指标 

Outcome:

The time of bacterial cultures becoming negative

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征

指标类型:

副作用指标 

Outcome:

Vital signs

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血、尿常规

指标类型:

副作用指标 

Outcome:

Routine blood and urine tests

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便隐血

指标类型:

副作用指标 

Outcome:

Fecal occult blood test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙氨酸氨基转移酶

指标类型:

副作用指标 

Outcome:

Alanine transaminase

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

天冬氨酸转氨酶

指标类型:

副作用指标 

Outcome:

Aspartate transaminase

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆红素

指标类型:

副作用指标 

Outcome:

Serum total bilirubin

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素氮

指标类型:

副作用指标 

Outcome:

Blood urea nitrogen

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

副作用指标 

Outcome:

Creatinine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

纤维蛋白原

指标类型:

副作用指标 

Outcome:

Fibrinogen

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血酶原时间

指标类型:

副作用指标 

Outcome:

Prothrombin time

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

部分活化凝血活酶时间

指标类型:

副作用指标 

Outcome:

Activated partial thromboplastin time

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

Electrocardiogram

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

AEs

Type:

Adverse events 

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:

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

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:

组织:

Sample Name:

Sputum

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

由独立的第三方通过中心随机化系统,采用动态最小化随机方法实施。

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

By an independent third party through the central randomization tem that uses dynamic stochastic

盲法:

由于中心随机化系统的研究者权限和药物管理员权限各自独立,由研究者和药品管理员分别登录操作。研究者权限下的受试者组别由随机化系统隐藏。在电子和纸质CRF中仅体现受试者随机号,不体现受试者组别。因此研究者和最终评价者在随访和评价时均不知道受试者组别。 两组使用的研究药物均采用避光输液器和遮光罩遮挡输注,避免受试者了解所在组别。

Blinding:

As central randomization tem researchers privileges drug administrator privileges independently by researchers pharmaceutical administrators to log on separately operation. Groups of investigators under the authority of the subjects by the random tem hidden. In the electronic paper CRF random numbers only reflect the subjects, the subjects do not reflect the . Therefore, researchers evaluators at the final follow-up evaluation are unaware subjects s. Two drugs used in the study are used dark infusion transfusion hood cover, avoiding subjects understwhere s.

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

天津中医药临床评价研究所

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

Tianjin Institute of Clinical Evaluation

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:

天津中医药临床评价研究所

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

Tianjin Institute of Clinical Evaluation

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-06-24
返回列表