| Objective With the improvement of people's living standards and the aging of the population,the prevalence of diabetes is increasing,which has a serious impact on the world's health system.Skin itching and blood sugar control interact,and treatment is difficult.This paper objectively analyzed the clinical effect of Danggui Yinzi in treatment of Yin Deficiency and Blood Dryness type diabetes comorbid with skin pruritusthrough randomized controlled trial,and evaluated its safety,explored the principle of its formulation and the basis of its argument,in order to provide an effective method for the treatment of this disease by traditional Chinese medicine.Methods (1)From October 2016 to October 2018,70 cases of diabetes comorbid with skin pruritus due to Yin Deficiency and Blood Dryness were treated in Endocrinology Department of Hubei Provincial Hospital of Traditional Chinese Medicine.After basic treatment of diabetes mellitus(knowledge publicity and education of diabetes mellitus + diet control + exercise therapy + hypoglycemic drugs).Following the principle of randomized control,70 patients were divided into control group(35 cases)and experimental group(35cases)by random number table method.There was no significant difference in age,sex,course of disease,blood sugar distribution,lipid metabolism,symptom score before treatment between the two groups(P>0.05),which was comparable.(2)All patients maintained the same basic treatment regimen for diabetes mellitus.Control group:diabetes basic treatment plus ebastine tablets,experimental group:diabetes basic treatment plus Angelica decoction.Our hospital unifies traditional Chinese medicine for decoction.One dose a day,decocted with water,200 ml each time,twice in the morning and evening,half an hour after meals.4 weeks as a course of treatment,a total of 2 courses of treatment.(3)To analyze the score and curative effect of diabetes mellitus and pruritus symptoms in two groups after treatment,and to analyze the changes of blood sugar before and after treatment,and to study whether it has statistical significance.(4)The changes of vital signs(body temperature,blood pressure,pulse,breathing),electrocardiogram,three routines,liver and kidney function,liver,gallbladder,spleen,pancreas and kidney color Doppler ultrasonography and adverse reactions were analyzed before and after treatment in the two groups for safety assessment.Results (1)In improving the symptoms of diabetes mellitus,intra-group comparison: Compared with before treatment,the scores of the first course of treatment in both groups decreased,and the decrease in the experimental group was more obvious.Paired t test showed that P<0.05.Compared with the first course of treatment,the scores of the experimental group decreased more significantly in the second course(P<0.05),and there was no statistical significance in the control group(P>0.05).Inter-group comparison:No matter the first course or the second course of treatment,the independent t-test of two samples showed that P<0.05.After treatment,the total effective rates of the experimental group and the control group were 94.29% and 77.14%,respectively.The comparison between the two groups showed that there was statistical significance(P<0.05).This study shows that the modified Danggui Yinzi group is better than the control group in improving the symptoms of diabetes mellitus,and the effect is more obvious when the course of treatment is prolonged properly.(2)In improving the symptoms of skin pruritus,intra-group comparison: compared with before treatment,the scores of the first course of treatment in both groups decreased,and the decrease in the experimental group was more obvious.Paired t test showed that P<0.05.Compared with the first course of treatment,the symptom score of the second course of treatment was further reduced,and that of the experimental group was more decreased.There was statistical significance between the two groups(P<0.05).It is suggested that both groups can significantly improve the symptoms of pruritus.Inter-group comparison:The comparison of the first and second courses of treatment between the two groups showed P<0.05,with statistical significance.The total effective rates of the experimental group and the control group were 97.14% and 85.71%,respectively.The comparison between the two groups showed that P<0.05,with statistical significance.This study showed that the modified Danggui Yinzi group was superior to the control group in improving the symptoms of skin pruritus.(3)In terms of improving blood sugar,intra-group comparison:FPG,2h PG and Hb A1 c decreased after treatment in both groups compared with before treatment,all showing P<0.05;Inter-group comparison:After treatment,the above indic-ators in the two groups were compared and showed P>0.05.Both groups can reduce blood sugar,and the improvement of blood sugar is similar,indicating that there is no significant difference between the two groups in improving blood sugar.(4)In terms of safety:The safety assessment of the experimental group and the control group was grade 1 and grade 2 respectively.There was no significant difference between the two groups(P>0.05).Conclusions The modifications of Danggui Yinzi can significantly reduce the syndrome score of patients with Yin Deficiency and Blood Dryness Type Diabetes Comorbid with Skin Pruritus,and the effect is better than that of ebastine,and the effect is better with the extension of treatment time.In this paper,the prescription basis of danggui yinzi addition and subtraction was analyzed,and the clinical experience of the tutor in the treatment of diabetes with pruritus was expounded,fully reflecting the overall concept and the characteristics of TCM treatment based on syndrome differentiation.In addition,The modifications of Danggui Yinzi's treatment of this disease has high safety,which can be promoted in clinical practice. |
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