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.
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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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.
Study Type
OBSERVATIONAL
Enrollment
18,260
Incidence of adverse drug reaction of cinepazide in department of neurology
Time frame: 1.5 years
Outcomes of the patients who experienced an adverse drug reaction of cinepazide.
Outcomes including cure, improved, null, or death.
Time frame: 1.5 years
The predictors of the adverse drug reaction of cinepazide
We will analyse whether some factors, such as age, gender, medical history and etc, would be the predictors of the adverse drug reaction of cinepazide.
Time frame: 1.5 years
Types of the adverse drug reaction of cinepazide.
The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc.
Time frame: 1.5 years
The treatment when patients experienced an adverse drug reaction of cinepazide.
Treatments including oxygen, steroids, and etc. According to severity of the adverse drug reactions, we will analyse the features the treatments, such as types and numbers.
Time frame: 1.5 years
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China Rehabilitation Research Center
Beijing, Beijing Municipality, China
Dongfang Hospital,the second clinical medical College of Beijing University of Chinese Medicine(BUCM)
Beijing, Beijing Municipality, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Fu Xing Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
Beijing, Beijing Municipality, China
Hua Xin Hospital; First Hospital of Tsing Hua University
Beijing, Beijing Municipality, China
Xuanwu Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
...and 51 more locations