Clinical study of Qinggan Bupi Jiangtang Decoction combined with western medicine in the treatment of adult type 2 diabetes mellitus with liver hyperactivity and spleen deficiency syndrome / 国际中医中药杂志

ABSTRACT

Objective:To evaluate the efficacy of Qinggan Bupi Jiangtang Decoction combined with western medicine in the treatment of adult type 2 diabetes mellitus (T2DM) with with liver hyperactivity and spleen deficiency syndrome.Methods:Prospective cohort study. A total of 103 T2DM patients with liver hyperactivity and spleen deficiency syndrome in the Department of endocrinology of Shanghai Municipal Hospital of Traditional Chinese Medicine from February 2020 to February 2021 were randomly divided into the observation group (52 cases) and the control group (51 cases) according to random number table method. Both groups were treated with conventional western medicine, the control group was treated with sitagliptin phosphate on the basis of routine treatment, and the observation group was treated with Qinggan Bupi Jiangtang Decoction on the basis of routine treatment. Both groups were treated for 12 weeks. TCM symptom scores were performed before and after treatment. The FPG, 2hPBG, HbA1c and fasting insulin (FINS) were detected by dry chemistry method and Roche electroluminescence method, and insulin resistance index (HOMA-IR) was calculated. The clinical efficacy was evaluated by dynamic blood glucose monitoring indexes TIR (percentage of time when glucose was in the range of 3.9-10.0 mmol/L), TAR (percentage of time when glucose was higher than the target range ≥ 11.1 mmol/L) and TBR (percentage of time when glucose was lower than the target range <3.9 mmol/L).Results:The total effective rate was 92.3% (48/52) in the observation group and 56.9% (29/51) in the control group ( χ2=15.32, P<0.01). The score of TCM syndrome in the observation group was significantly lower than that of the control group ( t=6.30, P<0.01). The compliance rate of HbA1c in the observation group was 46.2% (24/52) and that of the control group was 23.5% (12/51). There was significant difference between the two groups ( χ2=5.80, P=0.016). Compared with the groups before treatment, MAGE, TAR, TBR significantly decreased and TIR significantly increased in both groups after treatment ( P<0.01), but there was no significant difference between the two groups after treatment ( t values were 0.78, 1.06, 0.22 and 1.45, respectively, P>0.05). Compared with the groups before treatment, the levels of FPG, 2 hPBG and HbA1c in the two groups significantly decreased after treatment ( P<0.01), but there was no significant difference between the two groups after treatment ( t values were 1.32, 0.18,1.50, respectively, P>0.05). Compared with the groups before treatment, the levels of FINS and HOMA-IR in the two groups significantly decreased after treatment ( P<0.01), but there was no significant difference between the two groups after treatment ( t values were 1.25, 0.51, respectively, P>0.05). There were no adverse reactions in the observation group, 2 cases of mild nausea and 1 case of transient diarrhea in the control group. There was no significant difference between the two groups ( χ2=3.15, P=0.118). Conclusion:Qinggan Bupi Jiangtang Decoction combined with routine treatment can improve the blood glucose level, TIR and blood glucose standard rates of adult T2DM with liver hyperactivity and spleen deficiency syndrome, and the curative effect is equivalent to sitagliptin phosphate tablets.