| 【Objective】To observe and evaluate the clinical efficacy and safety of hirudo tongluo capsule combined with atorvastatin calcium tablets in the treatment of carotid atherosclerotic plaque in patients with qi deficiency and blood stasis,and to explore its possible mechanism of action,so as to provide new theoretical guidance for the treatment of carotid atherosclerotic plaque.【Methods】The prospective,randomized controlled study method was used to divide 60 patients who met the inclusion criteria of medical records into control group and 30 patients in treatment group.Patients in both groups were treated with conventional healthy lifestyle intervention,while the control group was treated with atorvastatin calcium tablets.On this basis,the treatment group was added to take the hirudo tongluo capsule.Four weeks was one course of treatment,and three courses of treatment were observed for 12 weeks.Intima-media thickness(IMT),maximum plaque area,plaque number,blood lipid,TCM symptom score,ecg,blood routine,liver and kidney function,and four coagulation tests were recorded before and after treatment.【Results】A total of 60 patients were included in this study,with no exfoliating cases.A total of 60 patients,30 in the control group and 30 in the treatment group were finally completed.(1)Intra-group comparison:(1)Both the control group and the treatment group had significantly lower IMT after treatment than beforetreatment,with statistically significant differences(P<0.01).Comparison between groups: the treatment group was significantly better than the control group in reducing IMT,and the difference was statistically significant(P < 0.01).(2)There was no significant change in plaque area and plaque number between the control group and the treatment group before and after treatment,and the differences were not statistically significant(P > 0.05).After treatment,there was no statistically significant difference in plaque area and plaque number between the two groups(P >0.05).(2)Blood lipid index:(1)The total cholesterol,triglyceride and LDL cholesterol in the control group and the treatment group were significantly lower than those before treatment,and the differences were statistically significant(P< 0.01).After treatment,the treatment group was significantly better than the control group in lowering total cholesterol,triglyceride and LDL cholesterol,with statistically significant differences(P < 0.01).(2)In terms of raising HDL cholesterol,there was no statistically significant difference between the groups before and after treatment and between the groups after treatment(P > 0.05).(3)Comparison of total score of TCM syndromes:(1)Comparison within the group: the total score of TCM syndromes in the control group and the treatment group after treatment was significantly improved compared with that before treatment,and the differences were statistically significant(P < 0.01).(2)Comparison between groups: the treatment group was better than the control group in improving the total score of TCM syndromes,and the difference was statistically significant(P < 0.05).(4)Comparison of TCM symptom efficacy:(1)The total effective rate of the control group was 73.33%,and the total effective rate of the treatment group was 96.67%.Through statistical analysis,the total effective rate of TCM symptoms in the treatment group was better than that in the control group,and the difference was statistically significant(P <0.05).(2)The apparent efficiency of the control group was 23.33%,and that of the treatment group was 56.67%.Through statistical analysis,the efficiency of TCM symptoms in the treatment group was significantly better than that in the control group,and the difference was statistically significant(P < 0.01).(5)Comparison of western medicine efficacy: Taking the change of carotid artery IMT as the evaluation standard of western medicine efficacy,the effective control rate of the control group was 73.33%,and the effective control rate of the treatment group was 93.33%.Through statistical test,the effective control rate of the treatment group was better than that of the control group,and the difference was statistically significant(P < 0.05).(6)Safety evaluation: During the treatment,patients in both groups did not experience any discomfort with oral drugs,and no abnormalities were found in the detection of four safety indicators,including electrocardiogram,blood routine,liver and kidney function and four coagulation tests.【Conclusion】The combination of hirudo tongluo capsule and atorvastatin calcium tablets was superior to that of the single western medicine group in the improvement of clinical symptoms of traditional Chinese medicine,carotid intima-media thickness,TC,TG and LDL-C,and no adverse reactions or abnormal safety indicators were found.It is concluded that the clinical efficacy and safety of hirudo tongluo capsule in patients with carotid atherosclerotic plaque are definite and worthy of further clinical research and promotion. |
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