| Purpose:Based on a review of the traditional Chinese medicine (TCM) theory of type2diabetes with hyperlipidemia, we set out to study the therapeutic efficacy of the Prescription of Removing Heat and Eliminating Bloodstasis on ths type of disease and understand the underlining mechanisms, by using randomized, controlled clinical trial.Methods:Sixty patients with the syndrome of stagnated heat of type2diabetes with hyperlipidemia were randomly classified into treatment group (n=30) and control group (n=30). On the basic of normal treatment and modern western medicine, the patients of treatment group were further treated by the Prescription while the patients of controll group were further treated by Xuezhikang Jiaonang.A course of treament was set as3months. The efficacy of treatment was assessed by asset of indices:curative effect indexes as clinical symptoms, FBG, PBG, HbA1c, blood fat concentration, hemorheology; inflammatory factors such as CRP, IL-6; safety indexes such as blood and stool test, routine urine, the function of liver and kidney, the harmful reaction and compliance of patients. All the data were analyzed by SPSS17.0statistical software.Results:Sixty cases were randomly divided into treatment group (29cases) and control group (28cases)(lost3cases). Prior treatment,the gender,age,course of disease,BMI of the two groups patients had no differences.(1) traditional Chinese medicine syndrome:two groups before and after treatment were improved, the treated group was better than the controlled group (P<0.05, P<0.01).(2) blood glucose:two groups of patients before and after treatment of fasting plasma glucose, postprandial2hours blood glucose, glycosylated hemoglobin were significantly decreased (P<0.05, P<0.01), there’s no significant differences between two groups CP>0.05).(3) blood fats:compared with pre-treatment, in the treated group patients’TC,TG,LDL-C were obviously lowered and HDL-C was rised(P<0.05, P<0.01). The controlled group patients’ TC,LDL-C,TG were lowered(P<0.05,P<0.01).The improvement of treated group patients’TG was better than the controlled one (P<0.05).(4) haemorheology:Significant decrease was observed in whole blood viscosity (high shear, cut and low cut5/s), plasma viscosity, blood sedimentation in the treatment group after treatment. After treatment,the whole blood viscosity (highly cuts,middle cuts,lowly cuts5/s), red cell rigidity index, red cell assembling index of both the treated group and controlled group dropped (P<0.05, P<0.01). The red cell assembling index of treated group improved(P<0.05),which was better than the controlled group.(5)inflammation factor:after treatment, the CRP, of the treated group were reduced (P<0.01) The CRP of the controlled group was decreased (P<0.05),but IL-6was no obvious difference. Comparison between two groups,the CRP, IL-6levels lower than the controlled group, with statistical differences (P<0.05).(6) Safety indicators:Blood biochemisty tesets showed that the liver and kidney function of treated group was within the normal range, and no adverse reactions were found in both groups.Conclusion:This preliminary clinical study indicated that treatment of western medicine and prescription of removing heat and eliminating bloodstasis is better than pure western medicine treatment. Chinese medicine treatment can improve clinical symptoms, reduce blood sugar, adjusting blood fat, also can improve the blood rheology, inflammation, and safe, effective.So it is worth studying deeply and developing further. |