| Objective:To observe the clinical efficacy of treatment of type 2 diabetes with insomnia and the influence on the psychological state and blood glucose condition of anti Jiaotai Pill and Huanglian ejiao Decoction,and evaluate its safety.Methods : According to the random number table,70 patients who met the diagnostic criteria of type 2 diabetes with insomnia were randomly divided into two groups.The actual enrollment cases were 33 cases in the test group and 32 cases in the control group due to reasons such as rejection and shedding.For all patients with diabetes,maintaining the original treatment plan,the experimental group was treated with Anti Jiaotai Pill and Huanglian ejiao Decoction.The control group was treated with Estazolam tablets,and the two groups of patients were given a health education to help maintain a good sleeping environment during the trial.4 weeks for an observation period,to assess the two groups of patients before and after treatment of clinical symptoms and psychological status,fasting blood glucose and other related indicators(including blood,liver and kidney function,etc.)changes,and record the course of treatment of adverse reactions.All data were analyzed using SPSS19.0software.Results:(1)Comparison of TCM syndrome scores: The total effective rate of the experimental group was 93.9%;the total effective rate of the control group was 53.1%;the total effective rate of the experimental group was better than that of the control group,and the difference was statistically significant(P<0.05).(2)Comparison of sleep quality: Compared with before treatment,the total PSQI scores of the experimental group and the control group decreased(P<0.05).After treatment,the total PSQI score of the experimental group decreased significantly and was superior to the control group(P<0.05).(3)Psychological state: Compared with before treatment,the SAS total score andSDS total score of both groups were decreased(P<0.05),but the SAS score and SDS total score of the experimental group were significantly lower than the control group.(P<0.05).(4)Fasting blood glucose: Compared with before treatment,the fasting blood glucose values of the experimental group and the control group were reduced(P<0.05),but the fasting blood glucose decreased significantly after the treatment in the experimental group,superior to the control group(P <0.05).(5)Safety evaluation: The blood routine and liver and kidney function of the two groups before and after treatment were all within the normal range.No adverse reactions and adverse events occurred during the whole study period.It was demonstrated that the anti Jiaotai Pill and Huanglian ejiao Decoction Modified Type 2Diabetes with insomnia is safe and reliable.Conclusions:(1)The anti Jiaotai Pill and Huanglian ejiao Decoction can obviously improve the clinical symptoms and improve sleep quality in patients with type 2 diabetes mellitus with insomnia(cardiac and kidney failure).(2)The anti Jiaotai Pill and Huanglian ejiao Decoction can improve the anxiety and depression status of type 2 diabetes patients with insomnia and contribute to the control of fasting blood glucose.(3)The treatment of type 2 diabetes with insomnia is safe and has no toxic side effects. |
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