| Objective: To observe the changes of related indexes of type 2 diabetes mellitus complicated with hyperuricemia and internal accumulation of dampness turbidity before and after the treatment with "Huazhuoqingli Decoction" based on the method of "removing turbidity,removing blood stasis and relieving triple energizer",and to evaluate the clinical efficacy and safety of "Huazhuoqingli Decoction",so as to provide basis for the traditional Chinese medicine treatment of type 2 diabetes mellitus complicated with hyperuricemia.Methods: According to the randomized controlled clinical study design,a total of 120 patients were collected from the Department of Endocrinology of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from June 2020 to September 2021.It was randomly divided into three groups,and 108 patients with type 2 diabetes mellitus complicated with internal accumulation of dampness turbidity were randomly divided into the Traditional Chinese medicine group,Western medicine group and Combination group.There were 34 patients in the Combination group,39 in the Traditional Chinese medicine group and35 in the Western medicine group.Traditional Chinese medicine group: basic treatment combined with Huazhuoqingli Decoction intervention;Western medicine group: basic treatment combined with uric acid reduction treatment;Combination group: basic treatment combined with uric acid reduction treatment and Huazhuoqingli Decoction intervention.As 4weeks was set as a course of treatment,patients in these three groups were observed for 2courses of treatment.The differences of blood glucose(FBG,Hb A1c),blood uric acid,Estimated Glomerular Filtration Rate,blood pressure,body weight,waist circumference,blood lipid(TG,CHOL,HDL-C,LDL-C),TCM syndrome score and other safety indicators were observed before and after treatment to evaluate the clinical efficacy.In this study,the data were statistical analyzed using SPSS 26.0 software.Results:(1)Baseline level: There was no significant difference in gender,age,diabetes course,body weight,waist circumference,blood pressure and other basic data between patients in the three groups before treatment based on the statistical software analysis(P <0.05).(2)Blood glucose level: After treatment,FBG and HbA1 c in patients in the three groups were significantly lower than those before treatment(P<0.05);The effect of combination group on the control of blood sugar was better than the other two groups(P < 0.05),TCM group was better than Western medicine group(P<0.05).(3)Serum uric acid level: SUA level in patients in the three groups was significantly lower than that before treatment(P<0.05);After the first course of treatment,The effect of Combination group on the reducing blood uric acid was better than the other two groups(P<0.05),Western medicine group was better than TCM group(P<0.05);After the second course of treatment,The effect of Combination group on the reducing blood uric acid was better than the other two groups(P<0.05),TCM group was better than Western medicine group(P<0.05).(4)Estimated Glomerular Filtration Rate level: e GFR level in patients in TCM group and Combination group was significantly lower than that before treatment(P<0.05);Combination group was better than TCM group(P<0.05),the improvement in e GFR was not significant in the Western medicine group(P>0.05).(5)Blood Lipid level: The changes of TG,CHOL,HDL-C and LDL-C of patients in the three groups before and after treatment were statistically significant(P<0.05).The effect of Combination group on the control of blood sugar was better than the other two groups(P<0.05),TCM group was better than Western medicine group(P<0.05).(6)Body weight,Waist circumference level: After treatment,BMI and Body weight of patients in the three groups were improved(P<0.05),but there were no statistical differences among the three groups(P<0.05).(7)blood pressure level: After treatment,blood pressure level of patients in the three groups were improved(P<0.05),but there were no statistical differences among the three groups(P<0.05).(8)TCM syndrome score: the scores of TCM syndrome in the three groups were improved significantly compared with before treatment(P<0.05),the symptom improvement in the Combination group was better than the other two groups(P<0.05),the symptom improvement in the TCM group was better than that in the Western medicine group(P<0.05).(9)Therapeutic effect of TCM syndrome: After treatment,the effective rate of TCM syndrome in patients in the Combination group was 94.11%,TCM group was 84.62%,and that of Western medicine group was 62.86%.The symptom improvement in the Combination group was better than that in the Western medicine group(P<0.05).(10)Total efficacy of disease: After treatment,the total effective rate of disease in patients in the Combination group was 88.24%,TCM group was 76.92%,and that of Western medicine group was 57.14%.The total efficacy of disease in the Combination group was better than that in the Western medicine group(P<0.05).Conclusion: Clinical studies have confirmed that based on the method of "removing turbidity,removing blood stasis and relieving triple energizer","Huazhuoqingli Decoction" has a remarkable effect on treating patients with type 2 diabetes complicated with internal accumulation of dampness turbidity,and it can obviously improve patients’ clinical symptoms,reduce blood sugar and uric acid,improve e GFR and body mass index,and improve blood lipid level.Through the observation of curative effect and safety of Huazhuoqingli Decoction,it was considered that this prescription is safe and effective,and is worth popularizing. |
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