Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 20,000
- 试验地点
- 15
- 主要终点
- The incidence of anaphylactic reaction to Breviscapine Powder-Injection
研究概览
简要总结
This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
详细描述
Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify 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 Breviscapine Powder-Injection in the monitoring departments of centain hospitals
排除标准
- 未提供
研究组 & 干预措施
Breviscapine Powder-Injection
Breviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc.
干预措施: Breviscapine Powder-Injection (Drug)
结局指标
主要结局
The incidence of anaphylactic reaction to Breviscapine Powder-Injection
时间窗: 1 years
次要结局
- The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection(1 years)
- The effective rate of Breviscapine Powder-Injection(1 years)
- The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection(1 years)
- The incidence of new SAEs to Breviscapine Powder-Injection(1 years)
- The incidence of new ADEs to Breviscapine Powder-Injection(1 years)
- The patient satisfaction rate for the therapy of Breviscapine Powder-Injection(1 years)
研究者
Zhong Wang
Dr
China Academy of Chinese Medical Sciences