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急性前循环血栓切除术患者预防性使用应激性溃疡药物与临床结果的关系

2026年11月2日更新者：Nanfang Hospital, Southern Medical University

急性前循环血栓切除术患者预防性使用应激性溃疡药物与临床结果的关联：一项前瞻性、多中心、观察性队列研究

Ischemic stroke accounts for a relatively high proportion of strokes. In recent years, intravenous thrombolysis and endovascular therapy have significantly improved the revascularization rate in patients with large vessel occlusive cerebral infarction, but 20-50% of patients still experience ineffective revascularization. Therefore, postoperative monitoring and treatment of patients with large vessel occlusions is crucial for early recognition, management and prevention of complications. Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, and a previously proven incidence of stress ulcer bleeding after ischemic stroke. Stress ulcer bleeding after ischemic stroke has been shown to be closely associated with unfavorable outcomes, such as mortality. Current national and international guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for the prevention of stress ulcers, but rather should be considered in the context of the patient's risk factors for stress ulcers and discontinued after the patient initiates enteral nutrition. However, there is no evidence-based medical evidence to support the risk-benefit relationship of stress ulcer drug prophylaxis in patients with mechanical thrombectomy for acute anterior circulation large vessel occlusion.

研究概览

地位

招聘中

条件

急性缺血性中风

详细说明

Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, of which only 0.5%-1% require blood transfusion or result in hypotension. Stress ulcer bleeding after ischemic stroke has been shown to be associated with poor outcomes, such as mortality, and basilar artery occlusion and middle cerebral artery cerebral infarction are independent risk factors for stress ulcer bleeding after acute ischemic stroke. Guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for stress ulcer prevention.

However, stress ulcer prophylaxis is initiated in most patients admitted to the neurological intensive care unit after mechanical embolization of acute anterior circulation large vessel occlusion. With advances such as diagnosis and early initiation of enteral nutrition, the rate of stress ulcer bleeding in patients with mechanical embolization of acute anterior circulation large vessel occlusion is significantly reduced. The relationship between the risk and benefit of SUP in patients undergoing mechanical embolization for acute anterior circulation large vessel occlusion is not yet supported by evidence-based medical evidence. Therefore, the purpose of this study was to investigate the correlation between pharmacological stress ulcer prophylaxis and clinical outcomes in patients undergoing mechanical thrombectomy for acute anterior circulation large vessel occlusion.

研究类型

观察性的

注册 (估计的)

2592

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Suyue Pan, M.D., Ph.D.
电话号码：13556184981
邮箱：pansuyue@smu.edu.cn

学习地点

中国
- Fujian
  - Fuzhou、Fujian、中国
    - 招聘中
    - Fujian Medical University Union Hospital
    - 接触：
      
      Shenggen Chen, M.D.
      
      电话号码：13459480275
- Guangdong
  - Dongguan、Guangdong、中国
    - 招聘中
    - Dongguan People's Hospital
    - 接触：
      
      Zhu Shi, M.D.
      
      电话号码：13669825459
  - Dongguan、Guangdong、中国
    - 招聘中
    - Dongguan donghua hospital
    - 接触：
      
      Lingyu Sun
      
      电话号码：13829203368
  - Guangzhou、Guangdong、中国
    - 招聘中
    - Nanfang Hospital of Southern Medical University
    - 接触：
      
      Suyue Pan
      
      电话号码：13556184981
  - Guangzhou、Guangdong、中国
    - 招聘中
    - Guangdong Provincial Hospital of Traditional Chinese Medicine
    - 接触：
      
      Lixin Wang, M.D.
      
      电话号码：13922793886
  - Guangzhou、Guangdong、中国
    - 招聘中
    - Huadu District People's Hospital of Guangzhou
    - 接触：
      
      Guangning Li, M.D.
      
      电话号码：13926239656
  - Guangzhou、Guangdong、中国
    - 招聘中
    - The Fourth Affiliated Hospital of Guangzhou Medical University
    - 接触：
      
      Wangchi Luo, M.D.
      
      电话号码：13710895142
  - Heyuan、Guangdong、中国
    - 招聘中
    - Heyuan people's Hospital
    - 接触：
      
      Minzhen Zhu
      
      电话号码：15007622318
  - Huizhou、Guangdong、中国
    - 招聘中
    - Huizhou Municipal Central Hospital
    - 接触：
      
      Lizhi Wang, M.D.
      
      电话号码：13802872076
- Hainan
  - Haikou、Hainan、中国
    - 招聘中
    - Hainan Provincial People's Hospital
    - 接触：
      
      Fan Zhang, M.D.
      
      电话号码：17389897580
  - Haikou、Hainan、中国
    - 招聘中
    - Haikou People's Hospital
    - 接触：
      
      Guoshuai Yang, M.D.
      
      电话号码：13876006248
  - Haikou、Hainan、中国
    - 招聘中
    - Hainan Traditional Chinese Medicine Hospital
    - 接触：
      
      Yong Gu, M.D.
      
      电话号码：15521280288
- Hunan
  - Changsha、Hunan、中国
    - 招聘中
    - The First Hospital of Changsha
    - 接触：
      
      Xu Peng, M.D。
      
      电话号码：15802507292
  - Hengyang、Hunan、中国
    - 招聘中
    - The Second Hospital University of South China
    - 接触：
      
      Yanhong Hu, M.D.
      
      电话号码：13265004191
  - Yueyang、Hunan、中国
    - 招聘中
    - Yueyang People's Hospital
    - 接触：
      
      Yuan Zhou, M.D.
      
      电话号码：15107309796
- Inner Mongolia
  - Baotou、Inner Mongolia、中国
    - 招聘中
    - Sinopharm North Hospital
    - 接触：
      
      Lifei Xing, M.D
      
      电话号码：15354919958
  - Hohhot、Inner Mongolia、中国
    - 招聘中
    - The Affiliated Hospital of Inner Mongolia Medical University
    - 接触：
      
      Lihua Sun, M.D.
      
      电话号码：18686292585
- Jiangxi
  - Ganzhou、Jiangxi、中国
    - 招聘中
    - Ganzhou City People's Hospital
    - 接触：
      
      Zhaohui Lai
      
      电话号码：13879729792
- Zhejiang
  - Wenzhou、Zhejiang、中国
    - 招聘中
    - Second Affiliated Hospital of Wenzhou Medical University
    - 接触：
      
      Saijun Zhou, M.D.
      
      电话号码：13857746659

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients who are treated with mechanical thrombectomy with acute anterior circulation large vessel occlusion. ≥18 years of age, within 24 hours of onset. Expected survival >3 months. NIHSS score ≥ 6 at onset of illness.

描述

Inclusion Criteria:

Age ≥18 years.
Within 24 hours of onset. Meet the criteria for diagnosis of acute ischemic stroke in the "China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018".
Meet the indications for mechanical thrombectomy in the "Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022".
Treated with mechanical thrombectomy.
NIHSS score ≥ 6 at onset of illness.
Sign an informed notice.

Exclusion Criteria:

Allergy to drug ingredients. Women who are pregnant or breastfeeding. Life expectancy of less than 3 months due to other non-ischemic stroke diseases such as malignancy, severe liver or renal failure.

Have participated in other interventional clinical studies (affecting the outcome of this cohort study).

Participants who were judged by the investigator to be unsuitable for participation in this study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Stress Ulcer Prophylaxis Subjects are on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission.
Control Group Subjects are not on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
90-day mortality after onset 大体时间：90-day after onset	Proportion of enrolled patients who died 90 days after onset of disease.	90-day after onset
Incidence of stroke-associated pneumonia 大体时间：within 7-day of onset	Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset	within 7-day of onset

次要结果测量

结果测量	措施说明	大体时间
Incidence of clinically significant bleeding 大体时间：within 7-day of onset	One of the following 4 symptoms occurs within 24 hours of bleeding from a stress ulcer (in the absence of other causes):1. A decrease of ≥ 20 mmHg in any one of systolic, diastolic and mean arterial pressure. 2.Initiation of blood pressure boosters or 20% increase in medication dose.3. Decreased hemoglobin ≥ 2 g/d(（1.24 mmol/l). 4.Infusion of erythrocytes ≥ 2 U.	within 7-day of onset
Incidence of stress ulcer bleeding 大体时间：7-day after onset	Coffee-like residue/black stool/blood in stool within 7-day after onset and more than 2 consecutive positive fecal/gastric fluid occult blood	7-day after onset
Incidence of unfavorable functional prognosis at 90 days after onset 大体时间：90-day after onset	Incidence of unfavorable functional prognosis at 90 days after onset	90-day after onset
90-day mRS score change 大体时间：90-day after onset	Modified Rankin Scale score change within 90 days after onset in patients who were eligible for inclusion criteria	90-day after onset
Incidence of early neurological deterioration 大体时间：within 72 hours after onset	Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4	within 72 hours after onset
1-year post-onset mortality 大体时间：1 year after onset	Mortality at 1 year after onset in patients who were eligible for inclusion criteria	1 year after onset
Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset 大体时间：1 year after onset	Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset in patients who were eligible for inclusion criteria	1 year after onset