| Objective:Evaluation of the efficacy and safety of Xuezhikang capsule in regulating blood lipids in patients with hyperlipidemia based on placebo control.Methods:This study was designed in a randomized,double-blind,placebo-controlled trial.The SPSS software was used to generate a random ranking list by computer for randomization and grouping,and the subjects who met the selection criteria were allocated according to the ratio of the treatment group and control group at 3:1.Xuezhikang capsule was taken orally in the treatment group,and placebo was taken in the control group.The dosage was 2 capsules/times,bid,took in the morning and evening after meals.Both the treatment group and the control group were given a 2-week cleaning period,during which diet and lifestyle intervention were carried out without taking any lipid-lowering drugs.Then,both groups should take medicine on the basis of diet and therapeutic life-style change,and the subjects were required to undergo corresponding examination items before and after treatment to evaluate the efficacy and safety of the drugs.Using SPSS 26.0 statistical software,T-test was used for data that conform to normal distribution,Wilcoxon rank sum test was used for non-conformance,and Chi-square test or Fisher’s exact probability test was used for rate comparison.Take the blood lipid baseline value as the covariable,the blood lipid level at the end of treatment as the dependent variable,and the group as the fixed effect to analyze the change value of the blood lipid index at the end of treatment compared with the baseline by analysis of covariance(ANCOVA).Results:1.The status of enrolled subjects:A total of 60 cases were completed in this study,including 45 cases in the treatment group and 15 cases in the control group.There were no excluded cases and shedding cases during the study period.2.Comparative analysis results of general conditions:There were no significant differences in sex,age,height,weight,vital signs,concomitant diseases and drugs,medication compliance,and clinical diagnosis types between the two groups(P>0.05).There was no significant difference in the baseline level of blood lipids between the two groups(P>0.05).3.Effectiveness analysis results:The results of self-control before and after treatment shown that the treatment group had statistical significance(P<0.05)and could improve the levels of TG,TC,LDL-C and HDL-C,while the control group had no statistical significance(P>0.05).After 8 weeks of treatment,the levels of TG,TC and LDL-C in the treatment group were significantly lower than those in the control group(P<0.05),but there was no significant difference in the level of HDL-C between the two groups(P>0.05).After deducting the influence of baseline level by covariance test,the comparison result of the change value in the end value and baseline value of blood lipid level was the same as that the result of after 8 weeks of treatment.After treatment,there was significant difference in the overall effective rate between the treatment group(93.33%)and the control group(46.67%)(P<0.001).4.Safety analysis results:During the study period,one adverse event occurred in the treatment group was xerostomia,and the rest didn’t have any adverse events and adverse reactions.There were no significant differences in liver,renal function,CK,and GLU level between the two groups before and after treatment(P>0.05).In addition,there was significant difference in blood pressure before and after treatment in the treatment group(P<0.05),but not in the control group(P>0.05).Conclusion:This study shown that Xuezhikang capsule has a significant effect on lowering blood lipid and good safety in clinical application.Meanwhile,it also has a synergistic antihypertensive effect,and it may have a certain protective effect on liver and kidney in patients with hyperlipidemia.Generally,Xuezhikang capsule can be used for the prevention and treatment of cardiovascular events by regulating blood lipid and lowering blood pressure. |
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