| Objective:To observe and evaluate the clinical effects and safety of ganluyin Decocting-free Chinese herbal medicine in the treatment of Type2Diabetes Mellitus with the pattern of dampness-heat with yin deficiency.Method:T2DM cases from the outpatient service of the Nephropathy and Internal secretion Department of Wangjing Hospital of China Academy of Chinese Medical Science were selected between March2013and February2013.The T2DM cases were randomly divided into a treatment group and a matched group,with30cases in each group. Patients in the two groups had taken Metformin HCL,500mg once,three times a day and for four weeks. Expect for the above drugs,patients in experimental group had taken ganluyin Decocting-free Chinese herbal medicine,everyday for4weeks.Before and after4weeks’treatment, Comparative analysis of changes of patients’clinical symptoms and signs, Fasting Blood Glucose(FBG),2hours post-meal blood glucose (2hPG), Glycated serum protein(GSP),pancreas islet function,hemorheology have been made. And the occurrence of adverse event such as the hepatorenal dysfunction and adverse drug reactions have been recorded during the treatment.Results:1The baseline condition between the two groups were comparableThe proportion of general condition such as gender, age, body mass index, symptoms and signs integral table, FBQ2hPG,GSP,pancreas islet function and hemorheology were compared. The difference between the two groups is not statistically significant (P>0.05). Patients in two groups were comparable.2The contrast of symptoms and signs integral table of two groups before and after the treatmentThe symptom and signs scores decreased in the treatment group at the14th and28th day There shows statistical significance(P<0.05) at the14th day,and more significant decrease (P0.01) at the28th day compared with that before the treatment.At the28th day of treatment, the symptom scores of patients in matched group shows difference(P<0.05). After4weeks of treatment, there is significant difference(P<0.01)in symptom scores of the treatment group compared with the control group at the14th and28th day.3The contrast of FBG before and after the treatment The FBG of patients in treatment group and in control group respectively decreased from7.74±0.99、7.72±0.98before the treatment, to5.76±0.86、6.58±0.32after the treatment. There is remarkable statistical significance (P<0.01) in the decrease of FBG in both the test group and the control group before and after treatment. After4weeks of treatment, there is statistical difference(P<0.05)in FBG of the treatment group compared with the control group4The contrast of the2hPG before and after treatmentThe2hPG of patients in treatment group and in matched group respectively decreased from11.09±2.53,10.41±2.34before the treatment, to7.89±0.9.7.39±0.23after the treatment. There is remarkable significant difference (P<0.01) in the decrease of2hPG in both the treatment group and the matched group before and after treatment.After4weeks’ treatment,there is not statistical difference (P>0.05) between the two groups.5The contrast of GSP before and after treatmentThe GSP of patients in treatment group and in matched group respectively decreased from3.18±0.31、3.28±0.32before the treatment, to2.64±0.36、2.77±0.18after the treatment. There is remarkable statistical significance (P<0.01) in the decrease of GSP in both of the two groups before and after treatment.After the treatment,the difference between the two groups is not significant (P>0.05).6The contrast of pancreas islet function before and after treatmentThe empty stomach C-peptide of patients in treatment group and in matched group respectively decreased from3.68±1.39,3.92±1.09before the treatment, to3.06±1.06,3.23±0.76after the treatment,and the2hours post-meal C-peptide from10.58±4.01,12.2±2.31before the treatment, to9.72±3.05、12.7±1.4. There is remarkable statistical significance (P<0.01) in the decrease of empty stomach C-peptide in both of the two groups before and after treatment. There is statistical difference(P<0.05) of decrease of2hours post-meal C-peptide in the test group,but no statistical difference in the control group before and after the treatment. After the treatment,the difference of empty stomach C-peptide between the two groups is not significant (P>0.05),while of the2hours post-meal C-peptide is remarkable statistically significant(P<0.01).7The contrast of hemorheological index before and after treatmentThe1st second shear rate of patients in treatment group and in matched group respectively decreased from21.83±2.15,20.92±2.6before the treatment, to17,76±2.62,19.68±2.11after the treatment,and the5th second shear rate from11.75±2.05,11.42±1.8before the treatment, to8.26±1.32、10.36±1.25; There is statistical difference (P<0.05) in the decrease of the1st shear rate in both of the two groups before and after treatment.There is statistical difference(P<0.05) of decrease of the5th second shear rate in the test group,but no statistical difference (P>0.05) in the control group before and after the treatment. After the treatment,the difference of the1st shear rate between the two groups is not statistically significant (P>0.05),while of the5th second shear rate is statistically significant(P<0.05).8Analysis of total effective rate of the two groupsAfter the treatment, the effective rate of the treatment group was86.7%,and33.3%of the control group.There is remarkable statistical significance(P<0.01) between the two groups.9Security EvaluationOf all the cases,the results of the routine examination of blood,urine and stool before and after the treatment didn’t show obvious anomalies. The change of liver function, renal function and other indicators of all patients was not statistically significant (P>0.05) before and after treatment, and neither adverse drug reactions nor adverse events were observed during the process.Conclusion:1Compared with simple Metformin HCL therapy, increasing ganluyin Decocting-free Chinese herbal medicine in the treatment of Type2Diabetes Mellitus with the pattern of dampness-heat with yin deficiency can effectively reduce abdomen turgor, dry mouse with more drink,uncomfortable diarrhea and other symptoms;2Compared with simple Metformin HCL therapy, increasing ganluyin Decocting-free Chinese herbal medicine in the treatment of Type2Diabetes Mellitus with the pattern of dampness-heat with yin deficiency can effectively reduce FBG;3Compared with simple Metformin HCL therapy, increasing ganluyin Decocting-free Chinese herbal medicine in the treatment of Type2Diabetes Mellitus with the pattern of dampness-heat with yin deficiency can effectively improve pancreas islet function;4Compared with simple Metformin HCL therapy, increasing ganluyin Decocting-free Chinese herbal medicine in the treatment of Type2Diabetes Mellitus with the pattern of dampness-heat with yin deficiency can effectively reduce blood viscosity;5The ganluyin Decocting-free Chinese herbal medicine for Type2Diabetes Mellitus with the pattern of dampness-heat with yin deficiency is safe. |
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