| Objective:1.To compare the lipid regulation effect in intervention of hyperlipidemia by TCM Differentiation and simvastatin.2.To compare the general clinical benefit in intervention of hyperlipidemia by TCM Differentiation and simvastatin.Methods:1. A total of 60 outpatients and inpatients with hyperlipidemia treated in the Endocrinology of our hospital between Feb.2015 and Dec.2015 who met the inclusion criteria were enrolled in this study.2.They were randomly divided into two groups,30 patients in the simvastatin group, namely control group and 30 patients in the TCM differentiation group, namely treatment group, according to a visiting sequence.3.Patients have been treated by traditional Chinese and western medicine specialists who are specialized in this field. The treatment group was guided by TCM differentiation and Chinese herb therapies, adopting Chinese medicine decoction, orally administered warmly 30 minutes after breakfast and supper, bid,14 days as a cycle. Patients in the control group were received simvastatin dispersible tablets 20 mg, qn. The treatment period was same to the treatment group.4.General clinical data were collected including patient’s lipids and liver function and so on related indexes, symptoms and signs. Those data were given statistical analysis.Results:1.TC:Both TCM differentiation and simvastatin have significant effects in reducing TC, P<0.01. For degree of lowering serum total cholesterol, the control group is greater than the treatment group, P<0.01.2.LDL-C:Both simvastatin and TCM differentiation have significant effects in reducing LDL-C, P<0.01. The reduction has no difference between two groups.3.HDL-C:HDL-C level is similar before and after treatment in two groups, whichindicates two therapies have not increased or decreased the HDL-C level,.P>0.05.4.TG:Simvastatin has slightly reduced the high TG level, P<0.05. In the aspect of lowering TG, there is no difference (P>0.05) before and after TCM differentiation. And there is no difference (P>0.05) after treatment between two groups.5.ALT:The difference (P>0.05) has no statistical significance after comparison within the treatment group while the difference (P<0.01) has remarkable statistical significance after comparison within the control group. ALT mean comparison in the control group: pre-treatment>post-treatment.6.AST:The difference (P>0.05) has no statistical significance after comparison wit hin the treatment group while the difference (P<0.05) has statistical significance after comparison within the control group. AST mean comparison in the control group:post-treatment>pre-treatment.7.Efficacy comparison of western medicine between two groups:18 patients have effective or excellent outcomes in the treatment group with an of 60% while 24 in the control group with an overall response rate of 80%. Chi-square test shows the difference (P<0.05) between groups.8.Efficacy comparison of TCM syndrome integration between two groups:28 Patients have effective or excellent outcomes in the treatment group with an ORR of 93.3% while 19 in the control group with an ORR of 63.3%. Chi-square test shows the difference (P<0.05) between groups.Conclusion:1. After two weeks of treatment, use of simvastatin on TCM syndrome differentiation and treatment can significantly decrease the TC and LDL-C levels.2.After two weeks of treatment, Compared with simvastatin,the treatment of TCM syndrome differentiation can reduce level of TC to a greater degree.3.In the process of the treatment of hyperlipidemia, TCM syndrome differentiation and treatment had no adverse effect on liver function, but simvastatin can increase the AST and ALT levels.4.Compared with simvastatin, not only can TCM syndrome differentiation release the TCM syndrome integral, but also alleviate the symptoms of hyperlipidemia patients suffering. |
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