Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan A Real World Study

Study Overview
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Brief Summary
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Magnesium Lithospermate B, the main constituent of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza), is the active ingredient of Salvia Miltiorrhiza. This study record clinical use of The injection of DanShenDuoFenSuanYan in the real world, and observe the adverse drug reactions/ adverse drug events during treatment.

Detailed Description
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As a traditional chinese medicine, the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza) was approved by State Food and Drug Administration of China in May,2005. This cardiovascular drug is one of the few Traditional Chinese Medicine pharmaceuticals where the active ingredients have been identified in the molecular levels. In its 8 years marketing in China, there is no serious adverse drug reactions. In this study, clinical pharmacists in selected hospitals will record the clinical use and the adverse drug reactions/ adverse drug events of this injection. This real world study for the Injection of DanShenDuoFenSuanYan with 30400 patients will be conducted from June.2012 to May.2014.

Official Title
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Post-marketing Safety Surveillance of the Injection of DanShenDuoFenSuanYan (the Injection of Depsides Salts From Salvia Miltiorrhiza): A Real World Study

Conditions
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Adverse Drug Reaction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who use the Injection of DanShenDuoFenSuanYan in 30 hospitals in china(including the inpatient and the outpatient(only in some hospitals which can get the information)). 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 |
| --- | --- |
| the Injection of DanShenDuoFenSuanYan<br>Patient who use the Injection of DanShenDuoFenSuanYan | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of IDSDFSY induced adverse drug reaction |  | 3 years | 
| The rare adverse drug reactions to the IDSDFSY |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The manifestation, treatment and outcomes of the ADRs | To describe manifestation, treatment and outcomes of the ADRs. | 3 years | 
| The risk factors of the ADRs | To examine the risk factors of the ADRs. | 3 years | 
| The patients' characteristics who are prescribed IDSDFSY | To describe the patients' characteristics who are prescribed IDSDFSY. | 3 years | 
| The prescribing pattern of IDSDFSY in real world clinical practice | To characterize the prescribing pattern of IDSDFSY in real world clinical practice. | 3 years | 
| Off-label use of IDSDFSY | To describe and evaluate the off-label use of IDSDFSY. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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the Injection of DanShenDuoFenSuanYan, Magnesium Lithospermate B, Safety, Real World Study