To evaluate the therapeutic evaluation of combination therapy with aspirin and salvianolate injection based on the population pharmacokinetics and TEG.A prospective, multicenter, randomized, controlled clinical trial is used.A total of 120 patients will be recruited and will be divided into three groups,respectively salvianolate injection group,aspirin group and salvianolate injection and aspirin group，and the course of treatment is 10 days.
1. Effectiveness evaluation:Primary Outcome Measure:Change of TEG（R time, K time, α angle, MA,CI,TPI）.Secondary Outcome Measures: Change of symptom score of the Seattle Angina Questionnaiire(SAQ).Change of ECG abnormalities.Change of score of traditional Chinese medicine(TCM) symptom curative effect rating scale. Change of platelet aggregation measured by light transmittance aggregometry(LTA).Change of serum lipids（TC、TG、HDL-C、LDL-C）.Change of fasting blood glucose.Population pharmacokinetics test(the detection of the blood concentration of magnesium lithospermate B and salicylic acid). 2. Safety evaluation:Change of PT,APTT,TT,FIB.Adverse events.Change of basic life sign.Gastrointestinal symptoms.Change of stool routine.Change of routine blood test.Change of urine routine.Change of liver function.Change of renal function.Change of fecal occult blood. 3. Number of participants:120 participants will be divided into three groups, the salvianolate group (n=40), the aspirin group(n=40) and the combination therapy group of salvianolate injection and aspirin(n=40). 4. Interventions:salvianolate injection group: salvianolate injection, intravenously infusion,0.2g/time, once a day; other routine treatment according to the condition of the disease.Aspirin group: aspirin, oral administration method,0.1g/time, once a day; other routine treatment according to the condition of the disease.Salvianolate injection and aspirin group: salvianolate injection, intravenously infusion,0.2g/time, once a day; aspirin, oral administration method,0.1g/time, once a day; other routine treatment according to the condition of the disease. 5. Course of treatment：10 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Traditional Chinese medicine injection，a kind of innovative drugs developed by Shanghai institute of materia medica, Chinese academy of sciences after 13 years of research and development.the content of magnesium acetate was 80%, and the other 20% were magnesium acetate.It has the function of promoting blood circulation,removing blood stasis and blood stasis,and is used for treating coronary heart disease with stable angina pectoris.
Molecular chemical formula: C9H8O4,molecular structure type: CH3COOC6H4COOH. It has the role of anti thrombosis In vivo, and it can inhibit the release of the platelet reaction, inhibit platelet aggregation, which is related to the reduction of TXA2 generation. Clinically itused to prevent the onset of cardiovascular and cerebrovascular diseases.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Change of thromboela-stogram（R time,K time,α angle,MA、CI、TPI）
Thromboela-stogram(TEG) Is a reflection of the dynamic changes in blood coagulation (including the formation rate of fibrin, the dissolution of the state and the consistency of the solid, elastic degree) of the index: R time is the latency of the first fibrin plaque formation. K time is to assess the rate at which blood clots reach a certain level. The alpha angle is similar to the K time, but is more comprehensive than the K time, and is not affected by the low coagulation state. MA reflects the maximum amplitude of blood clots. CI is an integrated coagulation index.TPI is the index of platelet kinetics
Time frame: Change from base line on the tenth day
Change of symptom score of the Seattle Angina Questionnaiire(SAQ)
SAQ includes 5 dimensions: the degree of physical activity limitation, the stable state of angina pectoris, the frequency of angina attack, the degree of treatment satisfaction, and the recognition of the disease
Time frame: Change from base line on the tenth day
Change of ECG abnormalities
ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris
Time frame: Change from base line on the tenth day
Change of score of Traditional Chinese Medicine(TCM) symptom curative effect rating scale
It includes the description of scores of symptoms, signs of tongue and pulse related to blood stasis syndrome of diagnosis of traditional Chinese medicine
Time frame: Change from base line on the tenth day
Change of platelet aggregation measured by light transmittance aggregometry(LTA)
The method is widely recognized, and is even considered a gold standard
Time frame: Change from base line on the tenth day
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SINGLE
Enrollment
120
Change of serum lipids（TC、TG、HDL-C、LDL-C）
Hyperlipidemia is one of the causes of angina. The measurement units of four indicators（TC、TG、HDL-C、LDL-C）are "mmol/L"
Time frame: Change from base line on the tenth day
Change of fasting blood glucose
It is one of the causes of angina(especially for patients with diabetes).The measurement unit is "mmol/L"
Time frame: Change from base line on the tenth day
The blood concentration of magnesium lithospermate B
Population pharmacokinetics test is in order to study the relationship between the population pharmacokinetics and clinical outcome. Magnesium lithospermate B is the main effective components of Salvianolate injection.The detection of the blood concentration of magnesium lithospermate B from both salvianolate injection group and salvianolate injection and aspirin group is necessary.
Time frame: At the discretional two time points from the time point after treatment(0h,0.25h(15min),0.5h,0.75h(45min),1h,1.17h(70min),1.33h(80min),1.67h(100min),2h,2.5h,3h,4h,5h,7h,9h,13h,25h)
The blood concentration of salicylic acid
Population pharmacokinetics test is in order to study the relationship between the population pharmacokinetics and clinical outcome. Salicylic acid is a kind of metabolite of aspirin. The detection of the blood concentration of salicylic acid from both aspirin group and salvianolate injection and aspirin group is necessary.
Time frame: At the discretional two time points from the time point after treatment(0h,0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,9h,10h,12h)