| Background and objective:Epidemiological surveys show that the incidence and mortality of atherosclerotic cardiovascular disease is increasing worldwide,hyperlipidemia is a major pathogenic factor for atherosclerosis,control lipids can significantly improve the prognosis of atherosclerotic diseases.Based on extensive clinical evidence in recent decades,statins have become the cornerstone of lipid-lowering therapy,statins will respond to an increase in PCSK9 which limit its lipid-lowering effects to some degree.The PCSK9 inhibitors are rarely used in clinical due to their high price、inconvenient use and other limitations,but at the same time the effect of xuezhikang capsules on PCSK9 are not clear,so this clinical research aimed at exploring the effect of xuezhikang on PCSK9 in patients with hyperlipidemia.Methods:All the patients were selected from June 2020 to February 2021,who were treated in the department of cardiology and the ward of the department of cardiology of the affiliated hospital of Nanjing University of Traditional Chinese Medicine and diagnosed as hyperlipidemia,all of them met the inclusion and exclusion criteria.The 60 patients included in the study were divided into an experimental group and a control group randomly,each with 30 patients.We used ELASA to test PCSK9 and used enzymatic methods to test LDL-C、TC、TG、HDL-C、CK、CK-MB,finally we observed the changes of PCSK9、lipid metabolism index、syndrome scores of traditional Chinese medicine and safety indexs between two groups.Results:1.Correlation between PCSK9 and various factors:PCSK9 had no correlation with age、BMI、basal LDL-C、TC、TG、HDL-C、TCM syndrome integral(P>0.05),PCSK9 showed a weak negative correlation with age and HDL-C,PCSK9 showed a weak positive correlation with other factors.There was no correlation between baseline PCSK9 and gender、hypertension、diabetes、ASCVD and TCM syndrome type.2.Main outcome indicators:①PCSK9:The PCSK9 of the observation group and the control group increased from 141.72±35.43ng/ml、143.31±31.05ng/ml before the treatment to 152.00±33.63ng/ml、160.19±35.33ng/ml after the treatment respectively.After treatment,both the observation group and the control group had no statistical significant(P>0.05),there was no statistical difference between the two groups(P>0.05).②LDL-C:The LDL-C of the observation group and the control group decreased from 3.60±0.50mmol/L、3.84±0.51mmol/L before the treatment to 2.25±0.50mmol/L、2.19±0.56mmol/L after the treatment respectively.After treatment,both the observation group and the control group were significantly decreased(P<0.01),there was no statistical difference between the two groups(P>0.05).③In the control group,ΔPCSK9(aftertreatment-beforetreatment)was positively correlated with ΔLDL-C(beforetreatment-aftertreatment)(r=0.47,P<0.05),while in the observation group,there was no correlation between ΔPCSK9(aftertreatment-beforetreatment)and ALDL-C(beforetreatment-aftertreatment)(r=0.229,P>0.05).3.Secondary outcome indicators:①TC:The TC of the observation group and the control group decreased from 5.76±1.04、6.18±0.72mmol/L before the treatment to 4.06±0.60、4.00±0.70mmol/L after the treatment respectively.After treatment,both the observation group and the control group were significantly decreased(P<0.01),there was no statistical difference between the two groups(P>0.05).②TG:The TG of the observation group and the control group decreased from 1.99±1.03、2.35±1.23mmol/L before the treatment to 1.32±0.55、1.58±0.81 mmol/L after the treatment respectively.After treatment,both the observation group and the control group were significantly decreased(P<0.01),there was no statistical difference between the two groups(P>0.05).③HDL-C:The observation group increased from 1.48±0.31 to 1.50±0.36mmol/L,the control group decreased from 1.56±0.47 to 1.44±0.29mmol/L,After treatment,both the observation group and the control group had no statistical significant(P>0.05).④:Syndrome scores of traditional Chinese medicine:After treatment,both the observation group and the control group were significantly decreased(P<0.01),there was no statistical difference between the two groups(P>0.05).⑤:Success rate of decreasing LDL-C:The control group was slightly better than the observation group(73.3%vs.70.0%),but there was no statistical difference between the two groups(P>0.05).4.Safety indexes:The two groups of drugs had little effect on AST、ALT、CK、CK-MB,and there was no statistical difference.All patients did not appear statin-related myalgia,rhabdomyolysis,fatigue,nausea and vomiting,abdominal pain and diarrhea,allergy and other symptoms.Conclusion:Xuezhikang capsule increased PCSK9 less than atorvastatin,and the lipid-lowering effect was similar to atorvastatin,with good safety and can be used actively in clinical practice. |
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