| Objective: To observe and evaluate the efficacy and safety of TCM decoction combined with western medicine in the treatment of abnormal lipid metabolism from the perspective of phlegm and dampness,and to compare the changes of TCM symptoms,TC,TG,LDL-C,HDL-C,Apo A1,Apo B,Ty G index,body weight,BMI,waist circumference and the occurrence of adverse reactions before and after treatment.Methods : To select Patients hospitalized and outpatient in Department of Endocrinology of Wuhan Hospital of Traditional Chinese Medicine from October 2019 to November 2020,they conforms to the diagnosis standard of western medicine dyslipidemia,and the syndrome differentiation of Chinese medicine is phlegm and dampness,research subjects were randomly divided into experimental group and control group according to random number table method,both groups received basic treatment,the control group was additively given pitavastatin calcium tablets on the basis of foundation treatment,2 mg,1 times a day,oral before sleeping,the experimental group on the basis of the control group with Chinese medicine decoction,2 times a day,200 ml each time,oral the warm of the medicine after breakfast and dinner,both groups of 6 weeks treatment,records the changes of patient’s general conditions,TC,TG,LDL-C,HDL-C,Apo A1,Apo B,Ty G index,safety indexes(three routine,liver function,renal function,electrocardiogram)and the traditional Chinese medicine symptoms of patients were recorded and scored,SPSS 26.0 software was used for statistical analysis,measurement data with mean±standard deviation(?X ± s)said,firstly,normality and homogeneity of variance tests were carried out,the results showed that the distribution was normal and the variance of the population was equal,paired sample t test was used for intra-group comparison before and after treatment,independent-sample t test was used for comparison between groups,if it does not fit the normal distribution or the variance is not uniform,the nonparametric test is used,paired-design rank sum test was used for intra-group comparison before and after treatment,the rank sum test of the two samples was designed completely randomly for comparison between groups,and Rank sum test was used for grade data,setαto 0.05,The difference was not considered statistically significant when P>0.05,When P<0.05,when P≤0.05,the difference was considered statistically significant.Results: A total of 71 subjects were included in this study,including 36 in the experimental group and 35 in the control group.Until the end of the experiment,the experimental group fall off in 1 case,the control group off 4 cases,finally completed the experimental group 35 cases,31 cases of control group is complete,the total loss rate is 7%,comparison between groups,the experimental group and control group of gender,age,BMI,the types of hyperlipidemia,TC,TG,HDL-C,LDL-C,Apo A1,Apo B,Ty G index,Chinese medicine symptom integral difference is not significant,and it’s comparable.1.Clinical efficacy was assessed according to blood lipid levels:the total effective rate of the experimental group was 91.43%,and the total effective rate of the control group was 87.10%.There was no statistical significance between the experimental group and the control group in judging clinical efficacy according to blood lipid levels(P>0.05),and the total efficacy of blood lipid was similar between the experimental group and the control group.2.Clinical efficacy was determined according to traditional Chinese medicine symptoms: the total effective rate of the experimental group was 94.29%,and that of the control group was70.97%,with statistically significant difference in efficacy between the two groups(P<0.05).The curative effect of traditional Chinese medicine symptoms in experimental group was better than that in control group.3.Comparison of traditional Chinese medicine symptom scores:intra-group comparison showed statistically significant differences in traditional Chinese medicine symptom scores between the two groups before and after treatment(P<0.05).Intergroup comparison showed that the experimental group was better than the control group in improving traditional Chinese medicine symptom scores,with statistically significant differences(P<0.05).4.Comparison of TC,TG,LDL-C,HDL-C,Apo A1 and Apo B: intra-group comparison showed that total cholesterol,triglyceride,low-density lipoprotein cholesterol,apolipoprotein B,and high density lipoprotein cholesterol,apolipoprotein A1 were decreased in both groups after treatment,and the difference before and after treatment was statistically significant(P<0.05).Compared with the control group,the experimental group was better than the control group in reducing total cholesterol,triglyceride,low density lipoprotein cholesterol,apolipoprotein B,and increasing high-density lipoprotein cholesterol and apolipoprotein A1 after treatment,and the difference was statistically significant(P<0.05).5.Ty G index: intra-group comparison showed that Ty G index decreased in both groups,with statistically significant difference before and after treatment(P<0.05).The decrease of Ty G index in the experimental group was better than that in the control group,and the difference was statistically significant(P<0.05).6.Body weight、BMI、waist circumference: intra-group comparison showed that both groups could reduce body weight,BMI,waist circumference,and the differences before and after treatment were statistically significant(P<0.05).Compared with the control group,the experimental group had the same effect on weight reduction(P>00.05),and the experimental group was better than the control group in improving BMI and waist circumference(P<0.05).7.Safety evaluation:In the control group,there was a slight elevation of transient transaminase in 1 case,which was not more than twice of the normal value,a slight nausea but tolerable in 1case,and diarrhea in 1 case,which was improved after symptomatic treatment.The incidence of adverse reactions in the control group was 9.69%,while no adverse reactions were found in the experimental group.Conclusion:To treat abnormal lipid metabolism from phlegm and dampness,TCM decoction combined with western medicine is superior to western medicine in reducing total cholesterol,triglyceride,low density lipoprotein cholesterol,apolipoprotein B,increasing high density lipoprotein cholesterol,apolipoprotein A1,improve insulin resistance and TCM symptoms,and reducing abdominal fat accumulation,and can reduce the occurrence of adverse reactions,with high security,this study also suggested that the combination of traditional Chinese medicine decoction and western medicine in the treatment of abnormal lipid metabolism may have a certain effect on improving the distribution of body fat and reducing the accumulation of visceral fat,which needs further verification. |