| Hyperlipidemia is an independent risky factor of atherosclerosis and coronary heart disease. Lowering blood lipid level therapy is considered a very important method in preventing and treating cardiovascular disease, so many lipid modifying drugs are developed for this cause. Many researches confirm that lower blood lipids can improve the function of endothelial tissue, reduce arterial plaque, thrombosis, and cardiovascular morbidity. Traditional Chinese medicine has its unique theoretical system to understanding of hyperlipidemia; and Chinese herbal medicine also has good effect in the prevention and treatment of hyperlipidemia. Pharmacological studies have a large number of evidence of single herb with lipid-lowering mechanism. Therefore, the project was designed to observe the effective and the safty in treating hyperlipidemia by used the composition of Yin-qiu capsules.Objective: Using Xue zhi kang as the control group, a preliminary evaluation of effective and safety for Yin-qiu capsules to treat hyperlipidemia in the type of spleen-qi deficiency with phlegm and blood stasis is provide for clinical reference.Methods:There were 32 study participates with hyperlipidemia at division of Cardiovascular of Traditional Chinese medicine Hospital in Nanjing.32 candidates were divided randomly into treatment group and control group which had 16 cases in each group. With the positive control of the experimental design methods, the control group took Xue zhi kang (each time 600mg,2 times a day) orally while the treatment group took the Yin-qiu capsules (540mg per day, providing by Yangtze River Pharmaceutical Group of Nanjing Hailing Pharmaceutical Co., Ltd.). Those two groups were treated for 12 weeks as a treatment plan.Patients in each group were observed the total clinical effective, the rating of pathogenic syndrome in Traditional Chinese medicine, and the level of serum lipids changes to analyze and evaluate the effective and safety of Yin-qiu capsuleâ…¡clinical study.Results:The clinical results in treatment group were markedly effective in 11 cases, effective in 4 cases, and insufficient effective in 1 case as the control group represented 9 markedly effective cases,5 effective cases, and 2 insufficient effective cases. The total effective rates of two groups were 93.76%,87.50%, which had no significant difference between treatment group and control group (P> 0.05). Secondly, the Traditional Chinese Medicine syndrome score in control group of dizziness, numbness in limbs, head heaviness and fatigue compared with treatment group's had great significant (P<0.05). Lastly, the level of lipid metabolism was observed. Both of treatment group and control group, the post-treatment compared with the pre-treatment in level of cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), and high density lipoprotein (HDL-C) had significant differences(P<0.001). The treatment group of high density lipoprotein (HDL-C) compared with the control group's considered significant (P<0.05). To lower the lipid levels in treatment group and control group had their strength and weakness. The efficacy of the treatment group was as much as the control group. During the clinical observation, there was no serious adverse events reaction.Conclusion:Yin-que capsules can be used for patients with hyperlipidemia (Spleen qi deficiency with Phlegm and Blood Stasis Syndrome) due to their functions of regulating blood lipid metabolism and improving Traditional Chinese Medicine syndrome scores. Comparing to Xue zhi kang, its control group, Yin-que capsules have similar clinical efficacy in lowering blood lipid level, better effects in Traditional Chinese Medicine syndrome scores, and less side effects. Therefore, they are safe and reliable in clinical use.
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