| Objective:To evaluate the efficacy and safety of acupoint application of Qianshan Huoxue Gao in the treatment of carotid artery plaques by observing the efficacy indexes and safety indexes.The potential mechanism was also studied to provide a research basis for the treatment of carotid plaques with acupoint application.That can provide new ideas for the prevention and treatment of carotid plaques with traditional Chinese medicine and new research ideas and treatment methods for the primary prevention of cerebrovascular diseases.Methods:60 patients with carotid plaques in the outpatient department of Department of Encephalopathy,Dongfang Hospital,Beijing University of Chinese Medicine were included.The patients were randomly divided into experimental group(30 cases)and control group(30 cases),which were given Qian Shan Huoxue Gao and Qian Shan Huoxue Gao Placebo respectively,and both groups were given basic drug Atorvastatin Calcium Tablets.The observation period was 90 days.The results what are detected by Color Doppler Ultrasound are intima-media thickness(IMT),number,size,nature of plaque,the blood velocity of the internal carotid artery(ICA),Crouse scores.They would be taken as the main observation indexes.The symptoms integrals,high-sensitivity C-reactive protein(hs-CRP),homocysteine(HCY),blood lipids,which is including total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),lipoprotein a[LP(a)],triglyceride(TG),apolipoprotein A1(Apo A1),apolipoprotein B(Apo B),and coagulation function,which is including activated artial thromboplastin time(APTT),prothrombin time(PT),fibrinogen(FIB),thrombin time(TT)as the secondary observation indexes.Vital signs,which is including Body temperature,Respiration rate,Pulse rate,Resting blood pressure,and blood routine,urine routine and microscopic examination of urine sediment,electrocardiogram,serum creatinine(Scr)and liver function,which is including alanine transaminase(ALT),glutamic oxalacetic transaminase(AST),alkaline phosphatase(ALP),total bilirubin(TBIL),gammaglutamyltransferase(GGT)were taken as safety indicators.The symptoms integrals,vital signs,adverse events were observed and recorded in the baseline period and 30 days,60 days,90 days after treatment.In the baseline period and 90 days after treatment,Carotid Ultrasound and blood lipid,hs-CRP,HCY,coagulation function,blood routine,urine routine,electrocardiogram,liver function and renal function were observed and recorded.and the safety and overall efficacy were evaluated.The experimental results were statistically analyzed by SPSS25.0.Results:In terms of baseline data,there were no statistic difference in gender,body mass index(BMI),education level,labor grade,diet preference,smoking history between the two groups(P>0.05),there were statistic difference in age and history of alcoholism(P<0.05).In terms of previous medical history,there was no difference in course of carotid plaque,incidence rate of hypertension,diabetes and hyperlipidemia and previous medication history between the two groups(P>0.05).For carotid ultrasound results,there was no statistic difference between the two groups in the total Crouse scores,the Crouse scores of the right carotid,IMT,the velocity of the internal carotid artery,the nature and location of the plaque(P>0.05),and the data are comparable.There was difference in Crouse scores in the left carotid(P<0.05).In terms of symptom scores,there was no statistic difference(P>0.05)between the two groups except for limb numbness(P<0.05).In terms of vital signs and physical and chemical indexes,there was no statistic difference(P>0.05)between the two groups except for AST(P<0.05).The data are comparable.After treatment,in the main efficacy indicators between the two groups,there was no difference in the Crouse score of the left plaque(P>0.05),but in experimental group it was lower than before,and in control group it was higher than before.The Crouse score of the right plaque in both the experimental group and the control group were decreased compared with the baseline period,but there was no statistical difference between the two groups after treatment(P>0.05).There was no statistic difference in bilateral IMT between the two groups before and after treatment(P>0.05),there was no statistic difference between the two groups after treatment(P>0.05),but the bilateral IMT showed a decreasing trend after treatment in experimental group and an increasing trend after treatment in control group.For PSV and EDV of the right internal carotid artery,there was no statistic difference between the two groups before and after treatment(P>0.05),but the experimental group was lower than before treatment,and the control group was higher than before treatment.There were no statistic difference in other maj or efficacy indexes between groups after treatment(P>0.05).As for the secondary efficacy indexes,the total symptom score and headache score in the experimental group were lower than those in the control group,and the difference was statistically significant(P<0.05).For TC,LDL-C and ApoB of experimental group and control group were decreased compared with before treatment,and the difference was statistically significant(P<0.05),but there was no statistic difference between groups(P<0.05).For security index,the two groups were no statistic difference except for ALT and AST(P<0.05).No serious adverse reaction occurred in the two groups during the treatment.The results of subgroup analysis showed that there was no difference between the control group and the experimental group in the right PSV before treatment in the 51?60 years old population(P>0.05),there was no difference between the two groups after treatment(P>0.05),but the experimental group after treatment was lower than before treatment,with statistically significant difference(P<0.05)and the control group was higher than before treatment.In the 51?60 group,the right EDV of experimental group showed a decreasing trend after treatment compared with before treatment,and the difference was statistically significant(P<0.05).The control group showed an increasing trend after treatment compared with before treatment,but there was no difference between the two groups(P>0.05).As for the group of the BMI<18.5,before treatment,there was no difference between the experimental group and the control group(P>0.05),there were difference between groups after treatment(P<0.05).APTT of experimental group was longer than before,and APTT of control group was shorter than before.In the experimental group,there was no difference in hs-CRP between those with and without diabetes before treatment(P>0.05),there was difference after treatment(P<0.05).Those without diabetes were lower than before and those with diabetes were higher than before(P<0.05).But in the control group,both the non-diabetic and diabetic groups showed an increase after treatment compared with before treatment.Conclusion:(1)Qianshan Huoxue Gao can reduce the left Crouse score,bilateral IMT,PSV and EDV of the right carotid artery in patients with carotid artery plaque.Qianshan Huoxue Gao can reduce right PSV and EDV in patients with carotid artery plaque aged 51?60 years.(2)Qianshan Huoxue Gao has the effect of reducing the total symptom score and headache score in patients with carotid plaque,and is superior to placebo.(3)Qianshan Huoxue Gao may prolong APTT in carotid plaque patients with BMI<18.5.Qianshan Huoxue Gao has different regulating effects on hs-CRP in carotid artery plaque patients without diabetes and with diabetes.(4)No serious adverse reactions were observed in the treatment of carotid plaque by acupoint application of Qianshan Huoxue Gao. |
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