The Clinical Research Of Treatment Of XinMai Capsule In Dyslipidemia In Phlegm And Blood Stasis Syndrome

Objective:The objectives of the trial are to observe the clinical therapeutic effect of "XinMai Capsule" for the patients with dyslipidemia in phlegm and blood stasis syndrome,and to evaluate its safety.Methods:We choose 40 patients with dyslipidemia in phlegm and blood stasis syndrome who are suitful for our research from the outpatients of Department of Cardiology in the third affiliated hospital of Nanjing University of T.C.M.It lasts from June to December in 2014.Then we divide them randomly into treatment group and contrast group,and observe them for 12 weeks.We give all the patients a health lecture and ask the to live in a healthy way.After that,the 20 patients in the treatment group take the XinMai Capsule 4 pills each time,3 times a day;the 20 patients in the contrast group take placebo 4pills each time,3 times a day. At the end of the research,we observe the change of the indexes of TC、TG、LDL-C、HDL-C and the TCM syndrome score,and all the indexes of safety including blood routine test、urine routine test、 urinary sediment microscopy(urine trace albumin,urine NAG enzyme,urine sugar,white blood cells and red blood cells),stool routine and blood biochemistry(ALT、AST、TBIL、r-GT、AKP、 BUN、Cr、GFR、CK)and ECGResults:1.the comparion of TCM syndrome score between the two groups:The difference between the TCM syndrome score of the patients before and after the treatment in the treatment group has statistical significance (P<0.05), the difference between the TCM syndrome score of the patients before and after the treatment in the contrast group doesn’t have statistical significance (P>0.05).The difference between the TCM syndrome score of the patients in the two groups after the treatment has statistical significance(P<0.05).The obvious effective rate of TCM syndrome score in the treatment group is 20%,while the total effective rate is 100%.It’s significantly higher than that of the contrast group(0%).The improvement of the patients’TCM syndrome in the treatment goups is better than that in the contrast group.2.The comparison of the blood lipid between the two groups:The difference between the result of TC、TG、LDL-C of the patients before and after the treatment in the treatment groun has statistical significance(P<0.05),while the difference between the result of HDL-C doesn’t have statistical significance(P>0.05).The difference between the the result of TG of the patients before and after the treatment in the contrast group has statistical significance(P<0.05),while the difference between the the result of the TC、LDL-C and HDL-C doesn’t have statistical significance(P>0.05).The difference between the results of the boold lipid of the two groups after the treatment has statistical significance except for HDL-C(P<0.05).The obvious effective rate of the treatment group is 85%,while the total effective rate is 100%.It’s significantly higher than that of the contrast group(5%).The effect of improving the blood lipid in the treatment group is better than that in the contrast group.3.Safety index:None of the patients have adverse reactions.The results of all the indexes of safety including blood routine test、urine routine test、urinary sediment microscopy、stool routine test、blood biochemistry and ECG are normal.Conclusion:1. XinMai Capsule is efficient in the treatment of dyslipidemia in phlegm and blood stasis syndrome,and it can reduce the patients’ uncomfortable symptoms.2. The security of XinMai Capsule is very good,it doesn’t have very apparent side effects.