| Objective:In clinical research, by observing the clinical efficacy and security of Heat-Removed and Blood Stasis-Eliminated Decotion among the patients of the Stagnated Heat Syndrome in the Type2Diabetes, clinical symptoms, blood glucose, glycated hemoglobin, blood lipids, blood rheology and other indicators was objectively evaluated before and after the treatment, which can broaden the train of thought for the clinical treatment and provide a new method of complementary advantages for the diagnosis and treatment with the integrated traditional Chinese and western medicine.In experimental research, under vitro culture conditions, the concentration gradient of Heat-Removed and Blood Stasis-Eliminated Decotion(QHYR), Cyclosporine A(CsA)+QHYR are observed to evaluate the viability of insulinoma cells (INS-1cells in rat, MIN6cells in mouse). The objective is to explore the curative effect and mechanism of QHYR on the patients of Stagnated Heat Syndrome in the Type2Diabetes, which may provide practical significance for clinical applications.Methods:1In the part of clinical research, a randomized controlled clinical trial was employed.50patients that met qualifying criteria for this study were randomly assigned to the treatment group and the control group by1:1.The25patients in the control group were treated with basic therapy, and others in the treatment group were treated with Heat-Removed and Blood Stasis-Eliminated Decotion as well as basic therapy. Three courses of treatment exist in the whole observation,4weeks for one course of treatment. To evaluate the clinical efficacy and safety, clinical symptoms scale scores was performed as well as blood glucose, glycated hemoglobin, blood lipids, blood rheology and other indicators.What’s more, liver function,kidney function, blood and urine routine examination were also included before and after the treatment for the evalution of clinical security.2In the part of experimental research, INS-1cell and MIN6cell are selected in vitro study of islet β cells. Two types of cells are each divided into2groups:QHYR Group (0mg/ml,0.5mg/ml,1mg/ml,2mg/ml,4mg/ml); CsA+QHYR Group (Islet cell are intervened by CsA study of islet β cells. Two types of cells are each divided into2groups:QHYR Group (0mg/ml,0.5mg/ml,1mg/ml,2mg/ml,4mg/ml); CsA+QHYR Group (Islet cell are intervened by CsA for48hours, induced the damage cell model; then add the QHYR Decoction(0mg/ml,0.5mg/ml,1mg/ml,2mg/ml,4mg/ml)). Cell viability is measured by MTT assay and cell morphology is observed.All data are expressed as Mean()±Standard Deviation (SD), using the SPSS19.0software for statistical analysis.Results:In the part of clinical research(1) Comparison of baseline information:50cases are confirmed and incorporated in the Stagnated Heat Syndrome of Type2Diabetes (25cases in the control group,25cases in the treatment group). There exist no significantly differences in gender, age, course, laboratory related indicators and TCM symptom in two groups of the patients.(2) Improvements in symtoms and signs:the individual TCM symptoms improved significantly in the patients of treatment group after the treatment, its effective rate is92%; while the control group is72%. By Ridit analysis, two sets of data have significant differences (P<0.05), the efficacy of TCM symptoms in the treatment group is better than the control group’s.(3) Improvement in blood glucose:After the treatment, the FBG,2hPBG and HbAlc are significantly reduced in patients of two groups (P<0.05). In the aspect of hypoglycemic effect, the effective rate of the treatment group is96%while the control group is80%. By Ridit analysis, two sets of data have significant differences (P<0.05), the hypoglycemic efficacy in treatment group is better than the control group’s.(4) Improvement in blood lipids:Compared with the control group before treatment between groups:TC, TG, LDL-C, HDL-C show no significant difference (P>0.05) in the therapeutic groups, both groups were comparable. Comparison in the group:After the treatment, TG,LDL-C are significantly reduced (P<0.05), while TC、HDL-C change without statistical significance in patients of control group. And after the treatment, there exist a significant difference in the decrease of TC、TG、LDL-C and the increase of HDL-C. Compared with the control group after treatment between groups:there are statistically significant differences (P<0.05) in TC, TG, HDL-C, while LDL-C are not significantly different in the treatment group.(5) Improvement in hemorheology:Compared with the control group before treatment between groups:High shearrate Blood Viscosity(HBV)[200/s], Medium shearrate Blood Viscosity(MBV)[30/s], Low shearrate Blood Viscosity(LBV)[5/s] and plasma viscosity values show no significant difference (P>0.05) in the therapeutic groups, both groups were comparable. Comparison in the group:After the treatment, LBV [5/s] significantly reduced (P<0.05), while HBV [200/s], MBV[30/s] change without statistical significance in patients of control group (P>0.05). And after the treatment, there exist a significant difference in the decrease of HBV [200/s], MBV[30/s], LBV [5/s] and plasma viscosity values. Compared with the control group after treatment between groups:there are statistically significant differences (P<0.01) in LBV [5/s] and plasma viscosity values, while HBV [200/s] and MBV [30/s] are not significantly different in the treatment group.(6) Two groups of patients showed no allergic reactions, and other serious adverse reactions during the treatment. Blood routine, urine routine, liver function, kidney function and other safety indicators showed no abnormalities before and after the treatment.In the part of experimental research(1) Individual Effect of QHYR Decoction on the cell viability of INS-1:Different concentrations of QHYR Decoction on the INS-1cells after24h, the cell viability of0.5mg/ml、1mg/ml、2mg/ml Group increased, compared with the Normal Control Group. And by the LSD one-way ANOVA,0.5mg/ml Group (P<0.01) and1lmg/ml Group (P<0.05) show a statistically significant in the increase of cell viability; while4mg/ml Group (P<0.05) shows a statistically significant in the decrease of cell viability.(2) Individual Effect of QHYR Decoction on the cell viability of MIN6:Different concentrations of QHYR Decoction on the MIN6cells after24h, compared with the Normal Control Group, the cell viability of0.5mg/ml、1mg/ml、2mg/ml Group increased, while the4mg/ml Group’s decreased. And by the LSD one-way ANOVA, there exists a statistically significant in the increase of cell viability in1mg/ml Group(P<0.05), compared with the Normal Control Group.(3) Effect of QHYR Decoction on the INS-1damage cell model induced by CsA:Compared with the Normal Control Group of INS-1which was cultured with conventional nutrient solution, cell viability significantly reduced (P<0.01) after INS-1cell was induced by CsA for48hours.0.5mg/ml、1mg/ml、2mg/ml、4mg/ml QHYR Decoction was given separately to the INS-1cell damage model for24hours, cell viability in0.5mg/ml and1mg/ml Group increased, compared with the CsA Group. Among them, cell viability of0.5mg/ml Group increased significantly (P<0.01), which showed no significant statistical differences with the Normal Control Group (P=0.109).(4) Effect of QHYR Decoction on the MIN6damage cell model induced by CsA:Compared with the Normal Control Group of MIN6which was cultured with conventional nutrient solution, cell viability significantly reduced (P<0.01) after MIN6cell was induced by CsA for48hours.0.5mg/ml、1mg/ml、2mg/ml、4mg/ml QHYR Decoction was given separately to the INS-1cell damage model for24hours, cell viability in lmg/ml Group increased, compared with the CsA Group (P<0.01), which showed no significant statistical differences with the Normal Control Group (P=0.723).Conclusion:1Through preliminary clinical study, a preliminary clinical studies, the therapeutic effect of basic treatment combined with Heat-Removed and Blood Stasis-Eliminated Decotion is better than the simple basic treatment’s. In clinical practice, the related clinical symptoms and signs can be improved in the patients of the Stagnated Heat Syndrome in the Type2Diabetes from the treatment group. Meanwhile, there exist significant effect and security in regulating blood lipids and glucose, improving hemorheology, which has a certain application and deserves deeper research.2In the aspect of experimental research, within a certain range of concentration, QHYR Decoction can evaluate the cell viability of INS-1cell and MIN6cell, have the effect of the protection and restoration on the cell damage model induced by CsA. What’s more, CsA on INS-1cell and MIN6cell inhibitory effect presents a certain dose-time dependencies. |
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