| Objective:By observing the Jingling Granule combined conventional western medicine treatment of qi and Yin deficiency,phlegm heat and stasis type primary hyperlipidemia patients,before and after the treatment of TCM syndrome integral,blood lipids and hemorrheology and inflammatory factor,vascular morphology,function change,evaluate objectively the clinical efficacy of Jingling Granule,to further explore the clinical value of Jingling Granule.Methods:60 patients with primary hyperlipidemia who met the diagnostic criteria and inclusion criteria of traditional Chinese and western medicine were selected and randomly divided into experimental group and control group,with 30 patients in each group.The control group was treated with Atorvastatin,and the experimental group was treated with Jingling Granule on the basis of the control group.The course of treatment was 8 weeks.The changes of TCM syndrome score,blood lipid,blood rheology,inflammatory factors,vascular morphology and function and safety indexes were observed before and after treatment in the two groups.Results:①Total TCM syndrome score and total effective rate:After treatment,the total TCM syndrome score of both groups was improved(P<0.01),and the experimental group was better than the control group(P<0.01);The total effective rate of experimental group was higher than that of control group.②Blood lipid:After treatment,TC,LDL-C and non-HDL-C in both groups were obviously decreased(P<0.01),while TG in experimental group was also decreased significantly(P<0.01),and the increase of HDL-C was also statistically significant(P<0.05).Compared with the control group,the decrease of TC and non-HDL-C was significantly different(P<0.01),and the difference of LDL-C was statistically significant(P<0.05),the experimental group was better than the control group;Compared with the control group,The number of patients of reaching the standard of blood lipid in the 10-years of ASCVD low-risk group was statistically significant(P<0.05).The rate of reaching the standard of blood lipid in the overall high,medium and low-risk group was statistically significant(P<0.05),and the experimental group was better than the control group.③Inflammatory factors:After treatment,IL-6 and IL-8 in both groups were improved(P<0.05).Compared with control group,IL-6 improvement in experimental group was significantly different(P<0.01).④Hemorrheology:After treatment,in both groups,except whole blood high shear viscosity[200/s],whole blood medium shear viscosity[30/s],whole blood low shear viscosity[5/s],whole blood low shear viscosity[1/s]and plasma viscosity decreased with statistical significance(P<0.05).Compared with the control group,the difference of whole blood low shear viscosity[1/s]was statistically significant(P<0.05).⑤Vascular morphology:There was no significant difference in bilateral cIMT between both groups before and after treatment(P>0.05).⑥Vascular elasticity function:After treatment,the decrease of bilateral common carotid artery PWV-BS and ES in both groups was statistically significant(P<0.01);The experimental group was better than the control group(P<0.05).⑦Safety indicators:After treatment,there was no significant difference in liver and kidney function between the two groups(P>0.05).Conclusion:Jingling Granule on the basis of western medicine can improve qi and Yin deficiency,phlegm and heat stasis type of primary hyperlipidemia patients with TCM syndrome integral,TC,LDL-C,TG,HDL-C,non-HDL-C,inflammatory cytokines IL-6,IL-8,the viscosity of whole blood shear[30/s],whole blood low shear viscosity[5/s],whole blood low shear viscosity[1/s],plasma viscosity index,arterial elasticity function.Moreover,the 10-year ASCVD risk population has a significant effect on the standard of blood lipid,with good safety,and has a broad prospect in the field of traditional Chinese medicine treatment of hyperlipidemia. |