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

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.

• Xueshuantong-Injection (Drug), also known as Chenzhong: Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.

Primary outcomes

• The incidence of severe adverse reactions (SAR) of Xueshuantong-Injection [2 years]: 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.

Secondary outcomes

• 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 [2 years]: The proportion of the patients whose drug effect is considered as "effective" by investigator

Sex: All

Inclusion Criteria:

* Patients who use Xueshuantong-Injection in the monitoring departments of certain hospitals

Exclusion Criteria:

* None

• Zhong Wang, M.D., Study director, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
• Jinmin Liu, M.D., Principal investigator, Dongfang Hospital Affiliated to Beijing University of traditional Chinese medicine