Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30,180
- 试验地点
- 36
- 主要终点
- The rare adverse drug reactions to the IDSDFSY
研究概览
简要总结
Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the real world, and observe the adverse drug reactions/ adverse drug events during treatment.
详细描述
As a traditional chinese medicine, the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza) was approved by State Food and Drug Administration of China in May,2005. This cardiovascular drug is one of the few Traditional Chinese Medicine pharmaceuticals where the active ingredients have been identified in the molecular levels. In its 8 years marketing in China, there is no serious adverse drug reactions.
In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection.
This real world study for the Injection of DanShenDuoFenSuanYan with 30400 patients will be conducted from June.2012 to May.2014.
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 the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information)).
排除标准
- 未提供
结局指标
主要结局
The rare adverse drug reactions to the IDSDFSY
时间窗: 3 years
The incidence of IDSDFSY induced adverse drug reaction
时间窗: 3 years
次要结局
- The patients' characteristics who are prescribed IDSDFSY(3 years)
- Off-label use of IDSDFSY(3 years)
- The manifestation, treatment and outcomes of the ADRs(3 years)
- The risk factors of the ADRs(3 years)
- The prescribing pattern of IDSDFSY in real world clinical practice(3 years)
研究者
Suodi ZHAI
Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital
Peking University Third Hospital