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Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia

注册号：

Registration number：

ITMCTR2100004353

最近更新日期：

Date of Last Refreshed on：

2020-10-29

注册时间：

Date of Registration：

2020-10-29

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

尤瑞克林联合天降血栓通丸在急性脑梗死rtPA溶栓治疗中的临床疗效观察

Public title：

Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

尤瑞克林联合天降血栓通丸在急性脑梗死rtPA溶栓治疗中的临床疗效观察

Scientific title：

Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia Running title: Clinical observation of therapeutic effect of TXP in acute cerebralischemia

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：

2018-SHGY-27

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：

ChiCTR2000039473 ; ChiMCTR2100004353

申请注册联系人：

李英红

研究负责人：

李英红

Applicant：

Yinghong Li

Study leader：

Yinghong Li

申请注册联系人电话：

Applicant telephone：

+86 15900294970

研究负责人电话：

Study leader's telephone：

+86 15900294970

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：

58747695@qq.com

研究负责人电子邮件：

Study leader's E-mail：

58747695@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：

天津市北辰区京津公路436号 脑病楼三楼

研究负责人通讯地址：

天津市北辰区京津公路436号 脑病楼三楼

Applicant address：

436 Beijing-Tianjin Highway, Beichen District, Tianjin, China

Study leader's address：

436 Beijing-Tianjin Highway, Beichen District, Tianjin, 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：

天津市北辰区中医医院

Applicant's institution：

Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional 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：

HS2008001-05

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

天津市北辰区中医医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tianjin Beichen District Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2018/1/27 0:00:00

伦理委员会联系人：

王建华

Contact Name of the ethic committee：

Jianhua Wang

伦理委员会联系地址：

天津市北辰区京津公路436号

Contact Address of the ethic committee：

436 Beijing-Tianjin Highway, Beichen District, Tianjin, China

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：

天津市北辰区中医医院

Primary sponsor：

Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

天津市北辰区京津公路436号脑病楼三楼

Primary sponsor's address：

436 Beijing-Tianjin Highway, Beichen District, Tianjin, 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)：

天津

市(区县)：

北辰区

Country：

China

Province：

Tianjin

City：

Beichen District

单位(医院)：

天津市北辰区中医医院

具体地址：

京津公路436号

Institution
hospital：

Tianjin Beichen District Hospital of Traditional Chinese Medicine

Address：

436 Beijing-Tianjin Highway, Beichen District

经费或物资来源：

区财政拨款

Source(s) of funding：

District Financial Allocation

研究疾病：

急性脑梗死

研究疾病代码：

Target disease：

Acute cerebral infarction

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：

分析尤瑞克林联合天降血栓通丸在急性脑梗死rtPA溶栓治疗中的临床疗效及安全性。

Objectives of Study：

To analyze the clinical efficacy and safety of Uricillin combined with TianJiang Xueshuantong Pills in the thrombolytic therapy of rtPA in acute cerebral infarction.

药物成份或治疗方案详述：

对照组:急性脑梗死溶栓时间窗内予阿替普酶溶栓治疗，用量每公斤体重0.9mg，最大剂量90mg,其中1/10于1分钟内静脉推注，其余部分融入0.9%氯化钠溶液100ml中1小时静点，静点结束后立即给予0.9%氯化钠溶液100ml+尤瑞克林0.15 PNA U静脉滴注，每日1次，同时降低颅内压、控制脑水肿、控制血糖、调整血压、清除自由基、活血化瘀、维持水电解质平衡、防治感染及醒脑开窍针刺等标准治疗，住院疗程10天。出院后给予口服我院天降血栓通丸 2丸，早晚餐后半小时口服至发病30天。 观察组：在对照组综合治疗基础上即刻予口服我院院内制剂，天降血栓通丸 2丸 早晚餐后半小时口服，住院疗程10天，出院后暂停口服天降血栓通丸10天后继续服用至发病30天。

Description for medicine or protocol of treatment in detail：

Control group: Patients with acute cerebral infarction were treated with rtPAwithin the thrombolytic time window, dosage 0.9 mg/kg, the maximum dosage was 90 mg, 1/10 of which was injected intravenously within 1 minute, and the rest was infused into 100 ml 0.9% sodium chloride solution for 1 hour. After the end of intravenous drip, the patients were given 100ml of 0.9% sodium chloride solution and 0.15PNA U of HUK once a day. At the same time, the standard treatments such as reducing intracranial pressure, controlling cerebral edema, controlling blood glucose, adjusting blood pressure, removing free radicals, promoting blood circulation and removingblood stasis, maintaining water and electrolyte balance, preventing and treating infection, and acupuncturing for resuscitation and resuscitation were also carried. The patients were hospitalized for 10 days. After discharge, the patients were given TXP(2 pills orally, half an hour after breakfast and dinner)for 30 days after the onset of the disease. Observation group: On the basis of comprehensive treatment, the observation group was given oral TXP immediately, 2 pills, half an hour after breakfast and dinner, and the course of hospitalization was 10 days. After discharge, oral administration of TXP was suspended for 10 days, and continued to be taken until 30 days after the onset of the disease.

纳入标准：

1)头颅影像学：颅脑CT示未见出血；颅脑MR示：DWI高信号；T2级T2flair未见异常； 2)符合中医中风诊断标准并存在以上所述主症者； 3)年龄在40~80岁之间； 4)急性起病，发病时间<4.5小时； 5）NIHSS评分4-20分的中度、中重度卒中患者； 6)VAS评分无显著差别； 7)血常规、凝血功能、肝肾功能均正常； 8)获得知情同意。

Inclusion criteria

1. Cranial imaging: Ct showed no hemorrhage. Brain Mr Showed high DWI signal. No abnormalities were found with T2 t2FLAIR; 2. The patient meets the diagnostic criteria of stroke in Chinese medicine and has the main symptoms mentioned above; 3. Aged 40 to 80 years; 4. Acute onset, onset time < 4.5 hours; 5. Patients with moderate and moderate to severe stroke who scored 4-20 points; 6. There was no significant difference in VAS scores; 7. Blood routine, coagulation function, liver and kidney function were all normal; 8. Obtain informed consent.

排除标准：

1）可疑蛛网膜下腔出血； 2）既往有颅内出血病史； 3）存在颅内肿瘤，动静脉畸形，动脉瘤； 4）近3个月有重大头颅外伤史或脑梗死病史；近1周内有在不易压迫止血部位的动脉穿刺史； 5）近期有颅内或椎管内手术； 6）血糖＜2.7 mmol/L；收缩压＞180mmHg，或舒张压＞110mmHg； 7）严重心、肝、肾功能不全或严重糖尿病患者； 8）伴有活动性出血； 9）急性出血倾向：包括血小板计数低于100*109/L或其他情况,；已口服抗凝剂者，且INR＞1.7或PT＞15s；48 h内接受过肝素治疗(APTT超出正常范围)；目前正在使用直接凝血酶或Xa因子抑制剂，且敏感的实验室指标(如APTT、INR，血小板计数、蛇静脉酶凝结时间、凝血酶时间或恰当的Xa因子活性测定等)； 10）CT提示低密度范围大于1/3大脑半球； 11）妊娠或哺乳期妇女； 12）过敏体质（对2种以上食物或药物过敏者）； 13）已知对本药品及rtPA过敏者； 14）2个月内曾参加其它药物试验者； 15）医师判定不能或可能不能完成本试验者。

Exclusion criteria：

1. Suspected subarachnoid hemorrhage; 2. A history of intracranial hemorrhage; 3. There are intracranial tumors, arteriovenous malformations, and aneurysms; 4. A history of major head trauma or cerebral infarction in the last 3 months; In the last 1 week, artery puncture occurred in the area not easy to compress hemostasis; 5. Recent intracranial or intraspinal surgery; 6. Blood glucose < 2.7 mmol/ L; Systolic bp > 180mmhg, or diastolic bp > 110mmhg; 7. Patients with severe heart, liver, renal insufficiency or severe diabetes; 8. With active bleeding; 9. Acute bleeding tendency: Including platelet counts below 100*109/ L or other conditions; Oral anticoagulant, and inr > 1.7 or pt > 15s; Heparin treatment within 48 h (APTT beyond normal range)Direct thrombin or factor XA inhibitors are currently being used, And sensitive laboratory indicators(Such as APTT, INR, Platelet count, Snake vein enzyme coagulation time, Thrombin time or appropriate factor XA activity determination); 10. Ct suggested a low-density range greater than 1/3 of the cerebral hemisphere; 11. A pregnant or lactating woman; 12. Allergic constitution(Allergic to more than 2 kinds of food or drugs); 13. Known to be allergic to this drug and RTPA; 14. Have participated in other drug trials within 2 months; 15. The physician determines that the participant cannot or may not be able to complete the study.

研究实施时间：

Study execute time：

从From 2018-07-01

至To      2020-07-01

征募观察对象时间：

Recruiting time：

从From 2019-01-01

至To      2019-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

50

Group：

experimental group

Sample size：

干预措施：

尤瑞克林+天降血栓通丸+阿替普酶

干预措施代码：

Intervention：

Human urinary kallindinogenase + Tianjian Xueshuotong pill + rtPA

Intervention code：

组别：

对照组

样本量：

50

Group：

control group

Sample size：

干预措施：

尤瑞克林+阿替普酶

干预措施代码：

Intervention：

Human urinary kallindinogenase + rtPA

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

天津

市(区县)：

北辰区

Country：

China

Province：

Tianjin

City：

Beichen District

单位(医院)：

天津市北辰区中医医院

单位级别：

三级甲等

Institution/hospital：

Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

神经功能缺损评分

指标类型：

主要指标

Outcome：

NIHSS

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

C反应蛋白和纤维状蛋白

指标类型：

次要指标

Outcome：

CRP and FIB

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量巴塞尔指数

指标类型：

主要指标

Outcome：

Barthel

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：

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：

结束

Completed

年龄范围：

最小 40 岁
Min age years
最大 80 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）：

符合纳入标准的患者将100例受试对象按就诊顺序编号1-100，采用计算机excel随机生成100个随机数字，随机数字按大小重新排序，1-50为对照组，51-100为观察组。

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

The patients who met the inclusion criteria numbered 100 subjects 1-100 in order of medical treatment, and 100 random samples were generated by computer Excel.

盲法：

由科住院或临床二线筛选病人，并签署知情同意书，随机分组，主管医师进行临床疗效评价及数据登记。科住院或临床二线分配口服天降血栓通丸或模拟剂后，再有其他主管护士给患者发放药物。

Blinding：

Patients were screened by the department of inpatient or second-line clinical screening And sign informed consent,randomized,Clinical efficacy evaluation and data registration were conducted by the competent physician the department of inpatient or second-line clinical will be assigned oral Tianjiangxuetong pills or simulators,Another nurse in charge dispensed medication to the patient.

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）：

课题结题后6个月, ResMan, http://www.medresman.org.cn。

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

Six months after the end of the project, ResMan, http://www.medresman.org.cn.

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：

科住院或临床二线病例筛选，进行分组；主管医师进行疗效评价，数据采集，填写CRP表

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

Department of hospitalization or clinical second-line cases were screened and grouped； The clinical efficacy was evaluated by the competent physician, data were collected and the CRF form was filled in。

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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