Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,260
- 试验地点
- 61
- 主要终点
- Incidence of adverse drug reaction of cinepazide in department of neurology
研究概览
简要总结
Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population. In order to improve the rational use of cinepazide, the investigators observe its clinical use in the real world in China, evaluate its safety and clinical benefit in a large Chinese population.
详细描述
Cinepazide was firstly approved in France in 1974, and the formulations are injection and tablet. Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain, Italy. In some Aisa countries, it has not been re-registered in Japan in 2000s, and the injection is still used in China and Korea. In china, Cinepazide Maleate Injection was approved by China Food and Drug Administration(CFDA) in 2002, and widely used in cerebrovascular disease. The safety of the Cinepazide, especially the adverse drug reactions in the blood system, has not benn fully evaluated in Chinese population. 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 Cinepazide Maleate Injection with 18000 patients will be conducted from Sep. 2012 to June. 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
- •Inpatient using the cinepazide in the department of neurology
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse drug reaction of cinepazide in department of neurology
时间窗: 1.5 years
次要结局
- Types of the adverse drug reaction of cinepazide.(1.5 years)
- Outcomes of the patients who experienced an adverse drug reaction of cinepazide.(1.5 years)
- The treatment when patients experienced an adverse drug reaction of cinepazide.(1.5 years)
- The predictors of the adverse drug reaction of cinepazide(1.5 years)
研究者
Suodi ZHAI
Suodi ZHAI, Department of Pharmacy, Peking University Third Hospital
Peking University Third Hospital