Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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.
Inclusion Criteria:
Exclusion Criteria:
Beijing, Beijing Municipality 100000, China
Beijing, Beijing Municipality 100005, China
Beijing, Beijing Municipality 100011, China
Beijing, Beijing Municipality 100191, China
Ganjiang, Guangdong 524000, China
Shantou, Guangdong 510000, China
Shantou, Guangdong 515000, China
Wuhan, Hebei 430040, China
Wuhan, Hebei 430050, China
Harbin, Heilongjiang 150000, China
Harbin, Heilongjiang 150000, China
Xi'an, Shaanxi 710000, China