| 1.Purpose To observe the clinical efficacy of Shenxiong granule in the treatment of cerebral infarction(stroke meridian-qi deficiency and blood stasis syndrome)and it’s influence on carotid atherosclerotic plaque,and provide evidence-based medical basis for it’s clinical application.2 Methods 2.1 Clinical data Sixty cases were collected from January 1st,2018 to October 31 st,2018,in the outpatient department or inpatient department of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine,and the recovery period of cerebral infarction was 35-75 years old(stroke Patients with meridians-qi deficiency and blood stasis syndrome.2.2 Test methods Using random number table method,60 patients with cerebral infarction recovery period(stroke meridian-qi deficiency and blood stasis syndrome)who met the inclusion criteria were randomly divided into treatment group and control group.Control group: unified oral aspirin enteric-coated tablets during the test period,100 mg/tablet early;atorvastatin calcium tablets: 10 mg/time night.Treatment group: control group(aspirin,atorvastatin)based on + shenxiong granules(specification: 20g/bag,3 times/day).Treatment: 90 days.Outpatient visits were followed up to 90 days after enrollment.2.3 Observation indicators Observe the TCM syndrome scores,NIHSS scores,modified Rankin scale scores,BI index,and SSQOL total scores before and after treatment.For patients with carotid atherosclerotic plaque,observe IMT and carotid atherosclerosis and the stability of the atherosclerotic plaque before and after treatment.3 Results 3.1 Clinical total efficiency,TCM syndrome efficacy The total effective rate of TCM syndromes in treatment group and control group was 93.33% and 73.33%,respectively.The total clinical effective rate was 93.33% and 80.00%,respectively.The total effective rate and total clinical effective rate of TCM syndromes in treatment group were excellent.In the control group,the difference was statistically significant.(P<0.05)3.2 TCM syndrome score,NIHSS score,modified Rankin scale score,BI index,SSQOL score total score comparison There was no significant difference in the scores of TCM syndromes,NIHSS scores,modified Rankin scale scores,BI index and SSQOL scores between the treatment group and the control group(P>0.05).TCM syndrome score,NIHSS score,and modified Rankin scale scores after treatment in the treatment group and the control group lower than before treatment,the total scores of BI index and SSQOL score were higher than those before treatment,and each score after treatment in the treatment group was significantly improved compared with the control group,and the difference was statistically significant(P<0.05).3.3 Comparison of carotid IMT and atherosclerotic plaque stability There was no significant difference in the IMT between the treatment group and the control group before treatment(P>0.05).There was no significant difference between the two groups after treatment(P>0.05),indicating that the treatment group and the control group were in this experiment.The carotid IMT was not improved during the observation period.The stability of carotid atherosclerotic plaques in the treatment group and the control group before treatment were 27.27% and 26.32%,respectively,and the difference was not statistically significant(P>0.05).The stability of carotid atherosclerotic plaque after treatment was 72.73% and 42.11%,the difference was statistically significant(P<0.05).3.4 Adverse reactions and adverse events in the two groups after treatment Patients who participated in this clinical trial didn’t discontinue and reject during the entire trial period,and no significant adverse events/events were observed.The treatment group and the control group didn’t affect the safety indexes such as liver and kidney function in a short period of time(P>0.05),and it was safe.4 Conclusion 4.1 Shenxiong granule can improve the TCM syndrome score of patients with cerebral infarction recovery period(stroke meridian-qi deficiency and blood stasis syndrome),and has a significant effect on the improvement of TCM syndrome efficacy.4.2 Shenxiong granules can improve the neurological deficit of patients with cerebral infarction recovery period(stroke meridian-qi deficiency and blood stasis syndrome),promote the recovery of physical function and living ability,and improve the quality of life.4.3 Shenxiong granules cann’t improve carotid intima-media thickness in a short period of time,but can increase the stability of carotid atherosclerotic plaque. |
