A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China
It is very common that Chinese Medicine Injection used in hospitals in mainland China.
However safety problems rose in recent years. There could be many uncertain factors
influence Chinese Medicine Injection in clinical practice.
Safety surveillance on Chinese Medicine injection is an important problem that needs to be
sorted out through large sample observational study.
A registry study for Shenqifuzheng injection safety surveillance with 30000 patients will be
conducted from Jan.2013 to Dec.2014.
Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction
All patients will be measured and assessed at the time Shenqifuzheng is administered to them until they discharge. Patients using Shenqifuzheng will be registered on a registration form including disease background, Shenqifuzheng's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shenqifuzheng
to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng
Xie M Yan
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
China: State Administration of Traditional Chinese Medicine of the People's Republic of China