Clinical Studies Of The Su-fat Soft Capsule For Treatment Of Primary Hyperlipidemia

Purpose:To investigate the curative effect and safety of SuZhiKang soft Capsule in patients with primary hyperlipidemia.Material and method:Randomization, double blindness, positive medicine control of clinical research method was used in this trial ,selected 48 suitable cases whom were parted two groups at random, patients in trial group was treated with the SuZhiKang soft Capsule 4 and Su-seed oil soft capsule simulation agent 4, Bid, taking a half-hour after breakfast and dinner; while control group was treated with Su-seed oil soft capsule 4 and SuZhiKang soft Capsule simulation agent 4, bid, taking a half-hour after breakfast and dinner. After 12 weeks of treatment, observe the level of TC,TG,LDL-C,HDL-C to evaluate drug efficacy. By observing all the patients the laboratory target (blood route, urine route, stool route, liver and kidney functions, ECG) and recording the bad events, evaluate the security of SuZhiKang soft Capsule.Results:After treatment, trial group TC, TG, LDL-C significantly lower than that before treatment, HDL-C was significantly higher than that before treatment, P<0.01, there was a statistically significant difference between them. control group TC, TG, LDL-C lower than that before treatment, P<0.01, differences were statistically significant, HDL-C tended to increase after treatment, P>0.05,but not statistically significant.In group comparison ,The change of lever of TC,LDL-C,HDL-C has a statistically significance ,P<0.05, while the TG had no significant difference between the two groups,P<0.05. Blood, liver function (ALT,AST), renal function(BUN,Cr) have no significant changes in the comparison between before and after treatment , and the patients had not any adverse reaction ,so SuZhiKang soft Capsule is safe. In this experiment, the number of sputum is 63.5 at the percent of the total number, so SuZhiKang soft Capsule can be used for the treatment of sputum, while the remaining syndrome also need a large sample of the study to be confirmed.Conclusion:1. SuZhiKang soft Capsule has a significant effect on lipid .2. SuZhiKang soft Capsule has a good drug safty.3. SuZhiKang soft Capsule can be used for the treatment of sputum.