Adverse Drug Reaction, Cinepazide, Stroke
Conditions
Keywords
Cinepazide, Adverse Drug Reaction, Safety, Real World Study
Brief summary
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.
Detailed description
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 Products containing cinepazide have been withdrawn in 1990s by the manufacturers because of lacking of demonstrated efficacy and the risk of agranulocytosis in some European countries, such as France, Spain,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.
Interventions
None listed
Sponsors
Beijing Sihuan Pharmaceutical Co. Ltd.
Beijing Shijitan Hospital,the 9th Clinical Medical College of Peking university
China Rehabilitation Research Center
Hua Xin Hospital First Hospital of Tsing Hua University
Fu Xing Hospital, Capital Medical University
Beijing Chuiyangliu Hospital(Beijing Minimally Invasive Hospital)
Dongfang Hospital Beijing University of Chinese Medicine
Dongzhimen Hospital, Beijing
Xuanwu Hospital, Beijing
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Southern Medical University, China
Guangzhou First People's Hospital
Panyu Hospital of Traditional Chinese Medicine
Second Affiliated Hospital of Guangzhou Medical University
The People's Hospital of Gaozhou
Zhongshan Hospital Of Traditional Chinese Medicine
Second Affiliated Hospital of Shantou University Medical College
Sun Yat-sen University
Central People's Hospital of Zhanjiang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Tongji Hospital
Renmin Hospital of Wuhan University
People's Hospital of Dongxihu District
Shenlong Hospital
Xiangya Hospital of Central South University
Central South University
The Third Xiangya Hospital of Central South University
Hunan Provincial People's Hospital
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
The Third Hospital of Changsha
Ankang City Central Hospital
San Er Ling Yi Hospital
Xijing Hospital
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Gansu Provincial Hospital
Xi'an Central Hospital
LanZhou University
Qilu Hospital of Shandong University
Binzhou People's Hospital
Jiangxi Provincial People's Hopital
The First Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
The Third Affiliated Hospital of Nanchang University
The Third Hospital of Nanchang
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Heilongjiang Chinese Medicine University
People's Hospital of Heilongjiang Province
The Second Affiliated Hospital of Harbin Medical University
The first hospital of Harbin City
The Fourth Affiliated Hospital of Harbin Medical University
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
First Hospital of China Medical University
People's Liberation Army No.202 Hospital
The Fourth Affiliated Hospital of China Medical University
General Hospital of Shenyang Military Region
The four six three hospital of people's Liberation Army
First People's Hospital of Shenyang
Jilin Province People's Hospital
Beihua University
Shenzhou Hospital to Shenyang Medical College
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Inpatient using the cinepazide in the department of neurology
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reaction of cinepazide in department of neurology | 1.5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcomes of the patients who experienced an adverse drug reaction of cinepazide. | 1.5 years | Outcomes including cure, improved, null, or death. |
| The predictors of the adverse drug reaction of cinepazide | 1.5 years | 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. |
| Types of the adverse drug reaction of cinepazide. | 1.5 years | The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc. |
| The treatment when patients experienced an adverse drug reaction of cinepazide. | 1.5 years | 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. |
Countries
China
Outcome results
None listed