Abstract
Background
Cerebral stroke is common and associated with high rates of mortality, disability, and recurrence while the chance of complete recovery is low. It adversely affects human physical and mental health and represents the leading cause of death in China. Aspirin is the cornerstone of secondary prevention of cerebral stroke. However, recurrence of stroke cannot be completely prevented by regular oral administration of aspirin due to aspirin resistance, which is an independent risk factor for stroke recurrence. In this instance, several strategies have been taken, including dose incrementation, frequency increaseof drug administration, combination with other antiplatelet drugs, or replacing it with new antiplatelet drugs. However, these measures have led to several other undesirable outcomes, including gastrointestinal tract stimulation, increased risk of bleeding, higher cost, and poor patient compliance to treatment.let aggregation, but its efficacy and mechanism in the secondary prevention Numerous studies have confirmed that Panax notoginseng has the effect of anti-plateof cerebral stroke among patients with aspirin resistance have not been ascertained.
Method/Design:
This is a two-center, triple-blinded, randomized, controlled, and optimal efficiency trial. A total of 120 patients aged 45–65 years old with semi-resistance to antiplatelet drugs treated in the secondary prevention clinics for cerebral stroke in the Shaanxi Traditional Chinese Medicine Hospital and Xi'an Hospital of Traditional Chinese Medicine from October 2020 to June 2022 will be recruited. Patients are randomly divided into the experimental group and control group at the ratio of 1:1, with 60 cases in each group. The blood pressure, blood glucose, and blood lipid are controlled within the normal range as the basic standards of treatment. The experimental group is given aspirin enteric coated tablets 100 mg/day + Panax Notoginseng Powder (3 g/day, oral administrationafter dissolved), while the control group is given aspirin enteric coated tablets 100 mg/day + placebo (Panax Notoginseng Powder 0.03 g + malt powder/day, oral administration after dissolved). Measurements on the platelet aggregation rate, thromboxane A2 (TXA2), prostacyclin (PGI2), adenosine diphosphate (ADP), and changes of the coagulation index of the two groups are performed on the day-14 and day-30. The efficacy, mechanism, and safety of Panax notoginseng in the treatment of patients with aspirin resistance will be evaluated. The data are analyzed and the mean and confidence interval (CI) of 95% level are calculated by the SPSS 21.0 software. The intention-to-treat (ITT) analysis is used to account for the missing data or dropouts. Descriptive analyses are performed on the baseline population data. Repeated ANOVA (general linear model) is used to compare the differences ofkey indicators (platelet aggregation rate, thromboxane A2, prostacyclin, ADP) between the two groups.For the secondary indicators (coagulation function), two independent samples t-test and Wilcoxon rank-sum test are used. P < 0.05 is considered a statistically significant difference between the two groups.
Conclusion
This study aims is to explore the efficacy and mechanism of Panax notoginseng in the secondary prevention for stroke patients with aspirin resistance. The results will provide evidence-based practice for traditional Chinese medicine, and also shed light on how it may influence the secondary prevention of cerebral stroke.
Trial registration:
The trial has been registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx,) on 24th October 2020, with the registration number ChiCTR2000037833.
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