Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study

Conditions
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Adverse Drug Event, Adverse Drug Reaction, Chinese Medicine, Anaphylactic Reaction

Intervention / Treatment
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* Drug: Breviscapine Powder-Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breviscapine Powder-Injection<br>Breviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc. | Drug: Breviscapine Powder-Injection<br>* 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.<br>* Other names: Zhusheyong Deng-zhan-hua-su;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of anaphylactic reaction to Breviscapine Powder-Injection |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection |  | 1 years | 
| The incidence of new SAEs to Breviscapine Powder-Injection |  | 1 years | 
| The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection |  | 1 years | 
| The incidence of new ADEs to Breviscapine Powder-Injection |  | 1 years | 
| The effective rate of Breviscapine Powder-Injection | The proportion of the patients whose drug effect is considered as effective by investigator. | 1 years | 
| The patient satisfaction rate for the therapy of Breviscapine Powder-Injection |  | 1 years |