| Objectives:The aim of this study was to evaluate the effects of Zhibitai capsule on blood lipids,arterial elasticity(measured by pulse wave velocity(PWV) and ankle-brachial index(ABI)) and plasma thromboxaneB2(TXB2) in patients with high cardiovascular risk, compared with Atorvastatin.The safety of Zhibitai capsule and Atorvastatin were assessed after 8-week treatment.Methods:Eighty three subjects with high risk factors of cardiovascular disease were randomizedly devided into Zhibitai group (n=44) and Atorvastatin group (n=39),and the course of treatment was eight weeks.The levels of blood lipids were assayed by clinical chemistry method. PWV and ABI were measured with an automatic device.Plasma TXB2 levels were measured with enzyme linked immunosorbent assay before and after treatment,respectively.The safety and tolerability of Zhibitai and Atorvastatin were evaluated at the end of the treatment.Results:1. In the two groups,the levels of triglyeride(TG),total cholesterol (TC) and low density lipoprotein cholesterol(LDL-C) were decreased markedly for 8 weeks (P< 0.05),but high density lipoprotein cholesterol (HDL-C) had no significant change (P>0.05).The variation of the TG, TC and LDL-C levels had no difference between two groups (P>0.05)2. Femoral-ankle PWV(FAPWV) and carotid-radial PWV(CRPWV) were decreased markedly after therapy with both Zhibitai capsule and Atorvastatin (P<0.05).No significant difference was found between the two groups (P>0.05). There were no obvious change in carotid-femoral PWV(CFPWV) and ABI in two groups (P>0.05)3. Plama TXB2 levels were reduced observably in two groups after therapy (P<0.05).The variation of the TXB2 levels had no difference between two groups (P>0.05)4. CFPWV was correlated with systolic blood pressure (SBP) (r=0.273,p=0.014),while CRPWV was correlated with diastolic blood pressure (DBP) (r=0.341,p=0.002).Plasma TXB2 level was correlated with SBP (r=0.272,p=0.030),TC (r=0.363,p=0.003),and LDL-C (r=0.297,p=0.017). There were no correlation between blood pressure,blood lipids and FAPWV,ABI. No significant association was observed between the extent of lipid reduction and fall in CRPWV, FAPWV or plasma TXB2. CFPWV and plasma TXB2 level were positively correlated(r=0.303,p=0.016),while FAPWV and ABI were negatively correlated (r=-0.248,p=0.028).5 The levels of alanine aminotransferase (ALT),total bilirubin (TBIL) and fasting blood sugar (FBS) were decreased evidently after therapy with Zhibitai for 8 weeks (P<0.05), but there were no significant alteration of them in Atorvastatin group (P>0.05).No significant changes of blood regulation and kidney function were found in two groups (P> 0.05).6. In Atorvastatin group,one patient withdrew from the study because of the liver pain.The side effects of Zhibitai were very mild, and the compliance of patients was very well.Conclusions:1. Zhibitai capsule has the same effects on reducing serum levels of TG,TC and LDL-C as Atorvastatin after 8 week treatment.2. Both Atorvastatin and Zhibitai can reduce the levels of FAPWV and CRPWV significantly, thus improving peripheral muscular medium-sized arterial elasticity,while ABI and CFPWV were not changed in the two groups.3. The level of plasma TXB2 was reduced obviously in the two groups after 8 week treatment suggesting that platelet activation and the contraction of thromboxane A2 (TXA2) on vasvular system may be reduced to some extent.4. Zhibitai may be effctive in treatment of abnormal liver function and lowering FBS.5. Zhibitai capsule was relatively safe and the side effects were rare. |
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