| Objective Under the combined action of rapid economic development,accelerating industrialization,changing lifestyle and aging population,the prevalence rate of diabetes is increasing,which has become a global public health problem.Insomnia and blood glucose control often interact and easily form a vicious cycle,it can easily lead to unsatisfactory treatment effect and affecting people?s quality of life.The purpose of this paper is to observe the clinical efficacy of Suanzaoren Decoction in the treatment of Yin Deficiency and Internal Heat type diabetes complicated with Insomnia and through randomized controlled experiment,evaluate its safety,explore its prescription principle,theoretical basis and modern pharmacological research evidence,in the hope of providing objective basis for the wide application of TCM in clinic.Methods(1)This paper collected 64 patients who were admitted to the Endocrinology Department of Hubei Provincial Hospital of Traditional Chinese Medicine from October 2017 to June 2019.According to the clinical symptoms and signs of the patients,a total of 64 patients were classified into diabetes mellitus combined with insomnia,Yin Deficiency and Internal Heat by TCM syndrome differentiation.According to the principle of randomized control,64 patients were divided into 32 in the control group and 32 in the treatment group.There were no statistically significant differences in age,gender,course of disease,blood glucose,lipid level,pre-treatment syndrome score and PSQI score between the two groups(P>0.05),indicating comparability.(2)The basic treatment of diabetes was maintained in both groups,the control group:basic treatment of diabetes plus estazolam tablets,the treatment group:basic treatment of diabetes plus Suanzaoren decoction.The hospital unifies decoct traditional Chinese medicine.One dose a day,decoted with water,150 ml each time,twice in the morning and evening,half an hour meals.After12 weeks of continuous medication,the relevant indexes of the two groups were compared,and the syndrome score and efficacy,clinical efficacy of insomnia,total score of PSQI,blood glucose and other indexes of the patients before and after treatment were compared to observe whether there was statistical significance,so as to evaluate the treatment effect.(3)The changes of vital signs(temperature,blood pressure,pulse and respiration),three routine procedures(blood analysis,urine analysis and stool analysis),liver and kidney function,electrocardiogram and other safety indicators before and after diagnosis and treatment of the two groups of patients,as well as the presence of other obvious adverse reactions,were observed for safety assessment.Results(1)In terms of improving syndrome score and syndrome efficacy: after 12 weeks of treatment,the syndrome score of the two groups of patients was compared with that before treatment(P<0.05);after treatment,the syndrome score of the two groups was compared between the groups(P<0.05),and the difference was statistically significant.The total effective rate of the treatment group and the control group was 90.62% and 68.75%,respectively,the difference was statistically significant,indicating that both therapies could improve the clinical symptoms and signs of patients,and the treatment group was significantly better than the control group in improving the syndrome score and syndrome efficacy.(2)In terms of improving the clinical efficacy of insomnia:the total effective rate of the treatment group and the control group was 93.75% and 75.00%,respectively.The comparison between the two groups showed P<0.05,which was statistically significant,indicating that the Suanzaoren decoction group was superior to the control group in improving the clinical efficacy of insomnia.(3)In improving the sleep quality(PSQI):12 weeks after treatment in both groups PSQI scores are compared with those of group before treatment(P<0.05),two groups of patients after treatment of PSQI score compared between groups(P<0.05),the difference was statistically significant,indicating that both treatments can improve sleep quality,Suanzaoren decoction addition and subtraction group was more helpful to improve the sleep quality of patients than estazolam group.(4)In terms of controlling blood glucose:FPG,2h PG and Hb A1 c in both groups were significantly improved after 12 weeks of treatment compared with before(P<0.05),and the improvement of blood glucose in the test group was better than that in the control group(P<0.05).The results showed that both therapies could improve the patients' blood glucose level,and the treatment group was superior to the control group in blood glucose control.Monitoring of safety indicators:there was no special discomfort before and after medication in the two groups,and there were no significant abnormalities in related safety indicators before and after treatment.The safety evaluation of the treatment group and the control group was level1 and level 2,respectively.The difference was not statistically significant(P>0.05).Conclusions Suanzaoren decoction addition and subtraction can significantly improve the syndrome score of patients with diabetes mellitus complicated with Insomnia and Internal Heat of Yin Deficiency,which is beneficial to the control of blood glucose level of patients,improve the quality of sleep,and the curative effect is better than that of estazolam tablets.In this paper,the principle of composition and the basis of the argument of Suanzaoren decoction addition and subtraction were observed and studied,summarizes the tutor's clinical experience in the treatment of diabetes merging insomnia,it fully embodies the concept of holistic concept and treatment based on syndrome differentiation of TCM,Suanzaoren Decoction addition and subtraction has high safety,little side effects and satisfactory curative effect in the treatment of this disease.It can effectively improve the quality of life of patients and can be widely applied in clinical practice. |
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