| Objective:Through randomized clinical trials evaluating preliminary efficacy and safety of Erchen Jiangzhi decoction in treating hyperlipidemia.Methods:Experiments using clinical research method of random, parallel control, from Chengdu University of Traditional Chinese Medicine affiliated hospital inpatient and outpatient cardiovascular department of internal medicine in accord with 80 newly diagnosed patients with primary hyperlipidemia diagnosis standard cases, were randomly divided into experimental group and control group,40 cases in each group, in addition to intervene in the same ways of life (including diet and exercise guide), the experimental group was given Erchen Jiangzhi decoction, daily a agent, cent is taken three times; the control group oral simvastatin 20mg, once a day.After 12 weeks of treatment, the patients of two groups were observed and recorded the total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), weight, body mass index (BMI), and the changes of liver and kidney function and syndrome of traditional Chinese medicine, and carries on statistics analysis.Results:1.The level of TC in the treatment group and the control group were decreased 0.86mmol/L and 1.11mmol/L, compared with those before treatment were significantly difference (P< 0.01),comparison of between group,the differences of two groups was not statistically significant after treatment; the level of TG average reduces 0.96mmol/L from treatment group, compared with before treatment were significantly difference (P< 0.01), compared with before treatment the control group TG level average decreased 0.54mmol/L,there is statistical significance (P< 0.05), after treatment comparison between two groups the difference has statistical significance(P<0.05);the two group can effectively reduce the LDL-C level,comparisons of the within group the differ is significant (P< 0.01),comparison of inter group the difference is no statistics significance (P> 0.05); after treatment the level of HDL-C had different degree improving of the treatment group and the control group, but the difference was not statistically significant (P> 0.05), the differences between groups were also no significant difference (P> 0.05); the total effective rate of treatment group was 94.5%, total effective rate was 92.1% in the control group, no significant difference between groups (P> 0.05).2.1n the same intervention way of life, after 12 weeks, weight drops respectively 1.88kg,1.12kg, intra group and inter group comparison showed no statistical significance (P> 0.05), but the treatment group had statistically significant in BMI decreasing(P< 0.05).3.Whether intra group comparison or inter group comparison,the TCM syndrome integral of two groups had statistically significant (P< 0.01), and in the integral improving aspect, the control group more than the treatment group(P< 0.01);the syndromes effective rate of two groups were 94.5% and 84.2%, there were statistic differences in the syndrome efficacy(P< 0.05).4.Compared with baseline,patients of two groups checking the function of liver,kidney and other safety indicators have no statistically difference (P>0.05).Conclusions:l.Erchen Jiangzhi Decoction can effectively reduce the levels of serum TC, TG, LDL-C, and the role of reducing TG was better than simvastatin; 2. Erchen Jiangzhi Decoction has certain effect in reducing weight, in test it effectively reduce the body mass index of treatment group; 3.Erchen Jiangzhi Decoction can obviously improve the TCM clinical syndromes of accumulation of Phlegm and Turbid type by hyperlipidemia patients, curative effect is better than simvastatin; 4 during the period of observation the treatment group did not appear related adverse drug reactions, the short-term treatment of Erchen Jiangzhi decoction is safe. |
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