Clinical Observation On Treatment Of Diabetes With Insomnia(internal Disturbance Of Phlegm-heat Type) By Xiaoke Bumei Fang

Objective: To observe the clinical efficacy and safety of Xiaoke Bumei Fang in the treatment of diabetes combined with insomnia(internal disturbance of phlegm-heat type),and provide a reliable basis for the TCM treatment of diabetes combined with insomnia,in order to further guide the clinical diagnosis and treatment.Methods: 62 patients with diabetes with insomnia(internal disturbance of phlegm-heat type)were randomly divided into the treatment group and the control group by the random digital table,31 cases in each group.On the basis of standardized hypoglycemic treatment in the two groups,the treatment group was treated with Xiaoke Bumei Fang,the control group was treated with Estazolam Tablets,After 12 weeks of continuous treatment,and compare the two groups with the clinical efficacy,related scale score(PSQI,ESS,ISI),TCM syndrome score,the curative effect of TCM Syndrome,glycosylated hemoglobin(Hb A1c)and adverse drug reaction,etc.To evaluate the efficacy and safety of Xiaoke Bumei Fang.Results:Before treatment,there was no significant difference in age,sex,course of disease,severity of disease and TCM syndrome score between the two groups(P > 0.05),and they were comparable.Comparing the two groups before and after treatment,the scores of TCM syndromes in each group were all lower than those before treatment(P<0.05),the treatment group which insomnia,dream,annoyance,chest and epigastric fullness and distress,phlegm,dizziness,pain symptoms score and control group which insomnia scores more obvious than before treatment(P<0.01);two groups after the treatment of PSQI score,ISI score,glycosylated hemoglobin(Hb A1c)were compared to treatment.Anterior reduction(P < 0.05).After treatment,the scores of TCM syndromes in the two groups were lower than those in the control group(P<0.05),and the scores of the chest and epigastric depression,the sputum and the pain symptoms were lower than those of the control group(P<0.01);and the PSQI score,ISI score and glycosylated hemoglobin(Hb A1c)in the treatment group were lower than those in the control group(P < 0.05).After treatment,the ESS score of the treatment group was lower than that before the treatment(P<0.05),and the ESS score of the control group was not significantly lower than that before the treatment(P>0.05).After the treatment,the two groups of ESS scores were significantly lower than those in the treatment group(P <0.05).After treatment,there was no significant difference in the comprehensive efficacy between the two groups(P>0.05),and the TCM syndrome in the treatment group was better than that in the control group(P<0.05).There were no special discomfort in the two groups before and after the drug use.The examination of three major Results: routinely,liver and kidney function,electrocardiogram,chest film,etc.There is no obvious abnormality.The results showed that all two groups of drugs had high safety.Conclusion: Xiaoke Bumei Fang can improve the clinical symptoms of traditional Chinese Medicine of diabetes with insomnia(internal disturbance of phlegm-heat type).It can improve the sleep quality of patients,improve the patients' night insomnia,improve their sleep efficiency,improve the mental state of daytime sleepiness,have a two-ways regulation effect on insomnia and drowsiness,and are conducive to blood glucose control in patients.This study shows that the decoction of flavored Xiaoke Bumei Fang is safe and effective in the treatment of diabetes with insomnia,and it is worthy of clinical application.