Clinical Observation Of Qizhu Pill In The Treatment Of Type 2 Diabetes Mellitus (Damp-Heat Trapping Spleen Syndrome)

Objective: To observe the safety and clinical effect of Qizhu pills in the treatment of type 2 diabetes mellitus(damp-heat trapping spleen syndrome).Methods: 70 patients who were diagnosed as type 2 diabetes mellitus(damp-heat trapping spleen syndrome)in the secretory outpatient of the second affiliated hospital of heilongjiang university of traditional Chinese medicine from September 2017 to September 2018 and who were treated with metformin and did not reach the standard of blood glucose control were randomly divided into the treatment group and the control group,35 in each group.To observe the effect of Qizhu pills on therapeutic indicators such as TCM syndrome total score,glycosylated hemoglobin(HbA1c),fasting plasma glucose(FPG)and 2h postprandial plasma glucose(2hPG)as well as related safety indicators,a randomized,parallel controlled trial was conducted with jinqi jiangtang tablets as the control drug.Results: 1.The TCM syndrome integral comparison: treatment group total effectiveness 90.91%,control group total effectiveness 84.38%,treatment group and control group all can improve the clinical symptoms,the treatment group and control group after treatment of TCM syndrome integral by the rank and inspection,P <0.05,the difference is statistically significant,which indicates that the treatment group in improving the TCM syndrome in patients with curative effect is better than that in control group,showed that Qizhu pills can improve operation in patients with type 2 diabetes(damp-heat trapping spleen syndrome)of TCM symptoms,reduce the TCM syndrome integral.2.Comparison of efficacy of FPG and 2hPG: FPG and 2hPG of the two groups were significantly reduced after treatment,P < 0.05,and the differences were statistically significant,indicating that both groups had the effect of reducing FPG and 2hPG.Compared with the control group after treatment,the treatment group after treatment of FPG and 2hPG were significantly lower,P < 0.05,with significant difference statistically significant,suggesting Qizhu pills metformin to reduce operation in patients with type 2 diabetes(damp-heat trapping spleen syndrome).FPG and 2hPG level is better than jinqi jiangtang tablets metformin in combination with metformin treatment.3.Comparison of efficacy of HbA1c: after treatment,HbA1 c levels in both groups were significantly reduced,P < 0.05,and the differences were statistically significant,indicating that both groups were able to reduce HbA1 c levels.Compared with the control group after treatment,the HbA1 c in the treatment group was significantly decreased after treatment,P < 0.05,and the difference was statistically significant,indicating that the combination of qizhu pill and metformin was better than the combination of jinqi jiangtang tablet and metformin in reducing the HbA1 clevel of patients with type 2 diabetes mellitus(damp-heat trapping spleen syndrome).4.Comparison of safety indicators: Intra-group comparison of liver function and kidney function before and after treatment in the two groups showed P < 0.05,with no statistically significant difference.There were no abnormal changes in blood routine,urine routine,electrocardiogram and vital signs during the treatment.Conclusion: 1.Qizhu pills can reduce TCM syndrome total score with type 2 diabetes mellitus(damp-heat trapping spleen syndrome).2.Qizhu pills can reduce FPG and 2hPG in patients with type 2 diabetes mellitus(damp-heat trapping spleen syndrome).3.Qizhu pills can reduce the level of HbA1 c in patients with type 2 diabetes mellitus(damp-heat trapping spleen syndrome).4.Qizhu pills had no effect on liver and kidney function.