Adverse Drug Reaction, Drug Allergy
Conditions
Keywords
Traditional Chinese Medicine Injection
Brief summary
Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.
Detailed description
As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.
Interventions
None listed
Sponsors
Shanghai Kaibao Pharmaceutical CO.,LTD.
Peking University
Handan First Hospital
Bethune International Peace Hospital of the Chinese PLA
The 254th Hospital of chinese People's Liberation Army
The 464th Hospital of chinese People's Liberation Army
People's Hospital of Cangzhou
The First Hospital of Qinhuangdao
The 44th Hospital of chinese People's Liberation Army
First Affiliated Hospital of Kunming Medical University
The Second Affiliated Hospital of Kunming Medical University
Chongqing Three Gorges Central Hospital
Sichuan Provincial People's Hospital
ShuangLiu Hospital of Traditional Chinese Medical
People's Hospital of Nanbu County
DuJiangyan Traditional Chinese Medicine Hospital
West China Hospital
Chongqing Traditional Chinese Medicine Hospital
The Third People's Hospital of Chongqing
Changsha Fourth Hospital
Hubei Xinhua Hospital
Wenzhou Central Hospital
Affiliated Yueqing Hospital of Wenzhou Medical University
The First Affiliated Hospital of Nanchang University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Minhang District Central Hospital
Shanghai First People's Hospital Branch
Zhejiang Provincial Hospital of TCM
The Affiliated Hospital of Hainan medical College
Guiyang Children's Hospital
Traditional Chinese Medical Hospital of Jiangxi Province
Jiangxi Provincial People's Hopital
Hubei Cancer Hospital
Jiangning District Hospital of Traditional Chinese Medicine
Shenzhen Third People's Hospital
Ningbo No. 1 Hospital
Second Hospital of Jilin University
The First Hospital of Jilin University
Yangzhou No.1 People's Hospital
Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
Bijie First Municipal People's Hospital
Guiyang Pulmonary Hospital
The 263rd Hospital of Chinese People's Liberation Army
Chongqing Kaixian County People's Hospital
The Second Affiliated Hospital of Chongqing Medical University
Chongqing Jiulongpo First People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Shenyang 242 Hospital
Second Affiliated Hospital of Guangzhou Medical University
Cancer Hospital of Guizhou Province
Wu Song Central Hospital of Shanghai
Gansu Provincial Hospital
Lanzhou Petrochemical General Hospital
Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
General Hospital of Ningxia Medical University
The First People's Hospital of Yinchuan
Yantai Municipal Laiyang Central Hospital
Shandong Cancer Hospital and Institute
Shandong University of Traditional Chinese Medicine
Zunyi Medical College
The 152nd Hospital of chinese People's Liberation Army
Henan Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
Central South University
The Second Hospital of Nanchang
The Second Hospital of Wulanchabu City
Qinghai Women and Childhood Hospital
The Third People's Hospital of Chengdu
The Center Hospital of Shuozhou
Yunnan Provinical Hospital of Traditional Chinese Medicine
Beijing Geriatric Hospital
Hubei Zhongshan Hospital Affiliated to Wuhan University
Anhui Provincial Children's Hospital
The Third Affiliated Hospital of Inner Mongolia Medical College
The fourth Hospital of Inner Mongolia
Zhongshan People's Hospital, Guangdong, China
Fenyang Hospital of Shanxi Province
The First Hospital Of Huhhot
Taiyuan Xinghualing Maternity & Child Health Care Center
The Fifth People's Hospital of Datong
Shanxi Provincial Maternity and Children's Hospital
The Second People's Hospital of Jinzhong
The Second Hospital of Hebei Medical University
People's Hospital of Rongcheng
Hebei Zhaoxian People's Hospital
Hejian Municipal People's Hospital
Xinle Municipal Hospital of Hebei
Capital Medical University
Fengtai district Hospital of Chinese and Western medicine, Beijing
Shanghai Changzheng Hospital
Xintai People's Hospital
Suodi ZHAI
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
24 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient. * Outpatients will be only in some hospitals which can get the patients' complete information.
Exclusion criteria
* Patients who are less than 24 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reaction of Tanreqing Injection | 30 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection | 30 months | Outcomes including cure, improved, null, or death. |
| Administration of Tanreqing Injection in real world | 30 months | — |
| Off-lable use of Tanreqing Injection | 30 months | — |
| Drug combination of Tanreqing Injection in real world | 30 months | — |
| Population characteristics of the adverse drug reaction of Tanreqing Injection | 30 months | — |
Other
| Measure | Time frame |
|---|---|
| Related Risk Factors in severe allergic reaction of Tanreqing Injection | 30 months |
Countries
China
Outcome results
None listed