| Objective:To observe the safety and effectiveness of Qingtan Huayu Anshen Decoction in the treatment of phlegm and blood stasis type diabetes mellitus with insomnia,and to put forward a new diagnosis and treatment idea for the treatment of phlegm and blood stasis type diabetes mellitus with insomnia.Methods:a randomized controlled study was conducted.According to the inclusion and exclusion criteria,86 patients with phlegm stasis type diabetes mellitus complicated with insomnia were included and randomly divided into observation group and control group,43 cases in each group.The observation group was treated with "original sugar control scheme combined with Qingtan Huayu Anshen Decoction",and the control group was treated with "original sugar control scheme combined with dexzopiclone".Both groups were treated for 4weeks.The TCM syndrome score,PSQI score,FPG,2h PG and HOMA-IR of the two groups were observed after treatment Objective to evaluate the safety and efficacy of Qingtan Huayu Anshen Decoction in the treatment of phlegm and blood stasis type diabetes with insomniaresult:1.A total of 86 patients were included in this study.They were selected from patients with phlegm and blood stasis type diabetes mellitus and insomnia who met the inclusion criteria in Long Yan Hospital of traditional Chinese medicine from December 2019 to November 2020.43 patients in each group were treated for 4 weeks.In the observation group,1 patient stopped the experiment due to taking other insomnia related drugs(No.27),and 1patient stopped the experiment due to unwilling to continue treatment In the control group,3cases stopped the experiment(No.09,45,56)due to refusing to accept treatment and follow-up,and 1 case stopped the experiment(No.79)due to taking other insomnia related drugs by himself,and 39 cases actually completed;after calculation,the sample shedding rate was 6.98%.2.Comparison of baseline data: before treatment,there were no significant differences in gender,age,course of diabetes,course of insomnia,education background,occupation,distribution of TCM syndrome,total score of TCM syndrome,distribution of insomnia degree,PSQI score,FPG,2h PG,HOMA-IR between the two groups(P > 0.05);3.In terms of TCM syndrome curative effect,after 4 weeks of treatment,the total effective rate of the observation group was 95.12%;the total effective rate of the control group was 64.10%;in terms of improving the syndrome curative effect of patients,the observation group was better than the control group;in terms of TCM syndrome total score,compared before and after treatment,both groups could improve TCM syndrome score(P <0.05)The difference was statistically significant(P < 0.05),and the observation group was better than the control group,the difference was statistically significant(P < 0.05);in terms of single TCM symptoms,the difference was statistically significant in improving "nightmares,easy to wake up,polydipsia,polyuria,mucositis and phlegm,palpitations and Zheng Zhong"(P<0.05)There was no significant difference between the two groups in improving "insomnia,eating more,wasting,dizziness,head and chest pain"(P > 0.05);4.In terms of PSQI score,before and after treatment,both groups could improve TCM syndrome score(P<0.05),and the observation group was significantly better than the control group,the difference was statistically significant(P < 0.05);5.In FPG,2hPG,after 4 weeks of treatment,there was significant difference between the two groups(P < 0.05).In terms of HOMA-IR index,after 4 weeks of treatment,the indexes of the two groups were significantly decreased,but the observation group was better than the control group,and the difference was statistically significant(P < 0.05),It shows that the observation group has more advantages in improving insulin resistance;6.During the clinical observation,all patients’ blood routine,liver function,renal function,ECG and other laboratory indicators were in the normal range;during the treatment,the observation group had no adverse reactions and adverse events,while the control group had 2 cases of vertigo,2 cases of drowsiness,1 case of nausea,1 case of abnormal excitement and 1 case of skin rash,in which vertigo and drowsiness occurred,P < 0.05,the difference was statistically significant There was no significant difference in nausea,abnormal excitement and rash(P > 0.05).Conclusion:Qingtan Huayu Anshen Decoction has obvious curative effect in the treatment of phlegm and blood stasis type diabetes with insomnia.It has more advantages in reducing TCM syndrome score,PSQI score and improving clinical symptoms than sedative and sleeping western medicine.At the same time,it can improve the disorder of glucose metabolism and reduce the insulin resistance.The clinical effect of Qingtan Huayu Anshen Decoction in the treatment of patients with phlegm and blood stasis type diabetes mellitus with insomnia is positive,with good safety and low incidence of adverse reactions. |
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