Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30,400
- 试验地点
- 90
- 主要终点
- Incidence of adverse drug reaction of Tanreqing Injection
研究概览
简要总结
Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.
详细描述
As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 24 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.
- •Outpatients will be only in some hospitals which can get the patients' complete information.
排除标准
- •Patients who are less than 24 months.
结局指标
主要结局
Incidence of adverse drug reaction of Tanreqing Injection
时间窗: 30 months
次要结局
- Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection(30 months)
- Administration of Tanreqing Injection in real world(30 months)
- Population characteristics of the adverse drug reaction of Tanreqing Injection(30 months)
- Off-lable use of Tanreqing Injection(30 months)
- Drug combination of Tanreqing Injection in real world(30 months)
研究者
Suodi ZHAI
Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital
Peking University Third Hospital