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This study was advocated by institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences in October 2011.
It was funded by China major scientific and technological specialized specialized project for 'significant new formulation of net drugs'.
Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart diswese、angina pectoris and stroke in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.
Full description
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 Medincine Injection in clinical practice.
Safety surveillance on Chinese Medincine injection is an important problem that needs to be sorted out through large sample observational dtudy.
A registry study for Kudiezi(Yueanxin) injection safety surveillance with 30000 patients will be conducted form Jan.2012 to Dec.2015.
Eligiblity crteria Patients who will use Kudiezi(Yueanxin) injection in selected hospitals.
Date will be collected in four aspects by four different forms as following:
Form A(blue):demographic information ;Form B(yellow):adverde drug events/reaction;Form C(white):extracted information from hodpiral information system and laboratory information system.
Enrollment
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Volunteers
Inclusion criteria
Patients using Kudiezi(Yueanxin) injection from 2012 to 2014
Exclusion criteria
none
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Data sourced from clinicaltrials.gov
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