Post-marketing Safety Surveillance of Xueshuantong-Injection : a Registry Study

Study Overview
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Brief Summary
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This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions.

Detailed Description
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Xueshuantong-Injection is a kind of natural compound injection with Panax notoginseng saponins(PNS). It's a popular drug for improving blood circulation that focusing on central retinal vein occlusion, stroke sequela, internal ophthalmopathy, hyphema and so on. However, more and more case reports about the adverse drug events of Panax notoginseng saponins have been reported in recent years. Therefore, this registry of Xueshuantong-Injection aims to monitor the safety and find the incidence of adverse drug reactions to Xueshuantong-Injection. Moreover, this registry is highly concerned on identifying the potential risk factors for the adverse drug reactions.

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

Conditions
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Adverse Drug Event, Adverse Drug Reactions, Anaphylactic Reaction, Severe Adverse Reactions

Intervention / Treatment
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* Drug: Xueshuantong-Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who use Xueshuantong-Injection in the monitoring departments of certain 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 |
| --- | --- |
| Xueshuantong-Injection<br>Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry. The investigators will record all the information about ADR, application of Xueshuantong-Injection and the combined medications, etc. | Drug: Xueshuantong-Injection<br>* Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.<br>* Other names: Chenzhong;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection | A serious adverse reactions (SAR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions (ADR) of Xueshuantong-Injection |  | 2 years | 
| The incidence of adverse events （AE）of Xueshuantong-Injection |  | 2 years | 
| The incidence of serious adverse events （SAE）of Xueshuantong-Injection |  | 2 years | 
| The incidence of anaphylactic reaction of Xueshuantong-Injection |  | 2 years | 
| The incidence of new ADRs of Xueshuantong-Injection |  | 2 years | 
| The effective rate of Xueshuantong-Injection | The proportion of the patients whose drug effect is considered as effective by investigator | 2 years |