A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
试验速览
- 阶段
- 不适用
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
研究概览
简要总结
The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.
详细描述
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
时间窗: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shuxuetong.
次要结局
未报告次要终点
研究者
Yanming Xie
Deputy Director, Professor
China Academy of Chinese Medical Sciences