The Clinical Research Of Dose-effect Relationship Of Huanglian Jiangtang Tablet In The Treatment In Type 2 Diabetes(Phlegm-heat Syndrome)

Objective: To observe the effects of different dosage Huanglianjiangtang Table in the treatment in type 2 diabete,and to know the dose effect relationship,effectiveness as well as safety,all those to provide scientific basis for the reform of dosage form and clinical medication.Methods:99 eligible patients were randomly selected in the outpatient department of Endocrinology in Kaifeng TCM hospital.Patients were randomly assigned to in the group of low dose of huanglianjiangtang tablet,the group of middle dose of huanglianjiangtang tablet and the high dose group of huanglianjiangtang tablet,which groups are were given the basic knowledge of diabetes education,dietary and exercise prescription reasonable.Except for the basic treatment of diabetes,the low dose group was taken the huanglianjiangtang tablet,2 tablets,3 times per day,and the middle dose group was taken Huanglian huanglianjiangtang tablet,4 tablets,3 times per day,and the high dose group was taken Huanglian huanglianjiangtang tablet,8 tablets,3 times per day;after 3 months,FPG,2hPG,HbA1 c,TC,TG,HDL-C,LDL-C,and other related indexes were observed and recorded before and after the treatment in the three groups.Results: 1.The efficiencies of TCM Syndrome:there was statistical difference between the high and middle dose group(P<0.05);there was statistical difference between the high dose group and low dose group(P<0.05);there was statistical difference between the middle and low dose group(P<0.05).2.The symptom integrals of TCM were reduced compared with those before the treatment in the high dose group of huanglianjiangtang tablet and in the middle dosegroup of huanglianjiangtang tablet(P<0.05);and there was no statistical difference in low dose group before and after the treatment(P > 0.05).Compared to the three groups:there was statistical difference between the high and middle dose group(P<0.05),and there was also statistical difference between the high dose group and low dose group(P<0.05);there was no statistical difference between the middle and low dose group(P> 0.05).3.The three groups of FPG,2hPG and HbA1 c were all reduced compared with those before the treatment(P<0.05).Compared to the three groups of FPG and 2hPG:there was statistical difference between the high and middle dose group(P<0.05);there was statistical difference between the high dose group and low dose group(P<0.05);there was statistical difference between the middle and low dose group(P<0.05).Compared to the three groups of HbA1 c,there was statistical difference between the high and middle dose group(P<0.05),and there was also statistical difference between the highdose group and low dose group(P<0.05);there was no statistical difference between the middle and low dose group(P> 0.05).4.The three groups of TC,TG and LDL-C were decreased compared with those before the treatment(P<0.05).Compared to the three groups of TC:there was statistical difference between the high and middle dose group(P<0.05);there was statistical difference between the high dose group and low dose group(P<0.05);there was statistical difference between the middle and low dose group(P<0.05).Compared to the three groups of TG and LDL-C,there was statistical difference between the high and middle dose group(P<0.05),and there was also statistical difference between the highdose group and low dose group(P<0.05);there was no statistical difference between the middle and low dose group(P>0.05).the high dose group of huanglianjiangtang tablet could increase HDL-C(P<0.05),but there were no statistical differences in the middle and low dose group before and after the treatment(P >0.05).5.After the treatment,there was no obvious abnormality in security tests,including the three frequent exams,liver function,kidney function and ECG.Conclusion: When FPG is within the range of 7-9mmol/L,2hPG is within the range of11.1-15mmol/L,different doses of Huanglian hypoglycemic tablets have a dose effect relationship and good safety in the treatment in type 2 diabetes.