[A comparative study of the efficacy and safety Zhibitai and atorvastatin].
OBJECTIVE
To compare the lipid lowing effect and the clinical safety between intensive therapy with Chinese medicine Zhibitai and atorvastatin in patients with moderate and high risk of atherosclerosis.


METHODS
All the patients were randomly divided in to a Zhibitai group (n = 85) receiving 480 mg of Zhibitai orally twice a day or an atorvastatin group (n = 84) receiving 10 mg atorvastatin orally once daily. Blood lipoproteins, myocardial enzymes, liver and renal function were measured before treatment and at the fourth and eighth week after therapy, while high sensitive c reactive protein (hs-CRP), P-selectin, matrix-metall proteinase-9 (MMP-9) and soluble intercellular adhering molecule-1 (SICAM-1) were detected before treatment and eighth week after therapy in all patients.


RESULTS
TC and LDL-C were significantly decreased while HDL-C was increased in both groups after 4 and 8 weeks treatment (P < 0.05). TG was decreased in Zhibitai group after 4 and 8 weeks of treatment, but it was decreased in atorvastatin group only after 8 weeks of treatment. Inflammatory factors such as hs-CRP, P-selectin, MMP-9, SICAM-1 were decreased significantly (all P < 0.01), but there was no significant difference between the two groups. There were no difference in liver and kidney function, myocardial enzymes and incidence of muscle-ache and digestive system side reaction.


CONCLUSIONS
Besides the lipoprotein disorder, inflammatory factors in patients with moderate and high risk of atherosclerosis could be regulated with intensive therapy of Zhibitai. Most importantly, it is safe to use Zhibitai clinically.
Xu
Dan-Yan
DY
Department of Cardiovascular Medicine, Second Xiangya Hospital, Central South University, Changsha 410011, China.
Shu
Jun
J
Huang
Quan-Yue
QY
Liu
Ling
L
Zhao
Shui-Ping
SP
D000368:Aged; D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069059:Atorvastatin; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006538:Heptanoic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*
D000924:Anticholesteremic Agents; D004365:Drugs, Chinese Herbal; D006538:Heptanoic Acids; D011758:Pyrroles; C553042:zhibitai; D000069059:Atorvastatin