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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xueshuantong-Injection | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xueshuantong-Injection | Drug | Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received the Xueshuantong-Injection for treatment will be consecutive included in this registry
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Wang, M.D. | Contact | 8610-64093140 | zhonw@vip.sina.com | |
| Yanan Yu, M.D. | Contact | 8610-64093140 | pumpkinnaicha@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhong Wang, M.D. | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | Study Director |
| Jinmin Liu, M.D. | Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jizhou City Hospital | Recruiting | Hengshui | Hebei | 053200 | China |
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Whole blood sample of the patient with severe adverse event
|
| 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 |
| Tongbai County People's Hospital | Recruiting | Nanyang | Henan | 474750 | China |
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| Lingbao 3th People's Hospital | Recruiting | Sanmenxia | Henan | 472500 | China |
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| People's Hospital of Dancheng County | Recruiting | Zhoukou | Henan | 477150 | China |
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| Dongxihu District People's Hospital | Recruiting | Wuhan | Hubei | 430040 | China |
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| Donghai Country People's Hospital | Recruiting | Lianyungang | Jiangsu | 222300 | China |
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| People's Hospital of Yichun City | Recruiting | Yichun | Jiangxi | 362201 | China |
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| Central Hospital of Wafangdian City | Recruiting | Dalian | Liaoning | 116300 | China |
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| Lingyuan City Central Hospital | Recruiting | Lingyuan | Liaoning | 222500 | China |
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| Chinse Medical Hospital of Yangxin County | Recruiting | Binzhou | Shandong | 251800 | China |
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| Weihai Wendeng District People's Hospital | Recruiting | Weihai | Shandong | 264422 | China |
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| Yangcheng County People's Hospital | Recruiting | Jincheng | Shanxi | 048100 | China |
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| Lingshi Country People's Hospital | Recruiting | Jinzhong | Shanxi | 031300 | China |
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| Shanxi Yuanping First People's Hospital | Recruiting | Yuanping | Shanxi | 034100 | China |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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