Adverse Drug Event, Adverse Drug Reaction, Anaphylactic Reaction, Chinese Medicine
Conditions
Brief summary
This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Detailed description
Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Interventions
DRUGBreviscapine Powder-Injection
Patients will be given Breviscapine Powder-Injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.
Sponsors
Zhong Wang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of anaphylactic reaction to Breviscapine Powder-Injection | 1 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection | 1 years | — |
| The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection | 1 years | — |
| The incidence of new ADEs to Breviscapine Powder-Injection | 1 years | — |
| The effective rate of Breviscapine Powder-Injection | 1 years | The proportion of the patients whose drug effect is considered as effective by investigator. |
| The patient satisfaction rate for the therapy of Breviscapine Powder-Injection | 1 years | — |
| The incidence of new SAEs to Breviscapine Powder-Injection | 1 years | — |
Countries
China
Outcome results
None listed