Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30,000
- 试验地点
- 14
- 主要终点
- The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
研究概览
简要总结
This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.
详细描述
Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals
排除标准
- 未提供
研究组 & 干预措施
Xueshuantong-Injection
Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry. The investigators will record all the information about ADR, application of Xueshuantong-Injection and the combined medications, etc.
干预措施: Xueshuantong-Injection (Drug)
结局指标
主要结局
The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection
时间窗: 2 years
A serious adverse reactions (SAR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.
次要结局
- The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection(2 years)
- The incidence of adverse events （AE）of Xueshuantong-Injection(2 years)
- The incidence of serious adverse events （SAE）of Xueshuantong-Injection(2 years)
- The effective rate of Xueshuantong-Injection(2 years)
- The incidence of anaphylactic reaction of Xueshuantong-Injection(2 years)
- The incidence of new ADRs of Xueshuantong-Injection(2 years)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences