| Objective:To observe the effectiveness and safety of Drainage No.8 Formula in the treatment of diabetic combined diarrhea with cold and dampness trapped in the spleen,and to provide new diagnostic ideas for the clinical treatment of diabetic combined diarrhea with cold and dampness trapped in the spleen.Methods:Seventy-two patients with diabetes mellitus combined with diarrhea who met the inclusion and exclusion criteria from January 2021 to December 2021 in the outpatient and inpatient wards of the Department of Endocrinology,Xiamen Hospital of Traditional Chinese Medicine Hospital was selected and randomly grouped into two groups: 36 patients in the experimental group were treated with " Shuxie No.8 Decoction " and 36 patients in the control group were treated with "Bifidobacterium trixylans capsules 4 tablets tid".The changes of the Chinese medicine symptoms score,diabetic patients’ survival quality specificity scale score,stool characteristics score,fasting blood sugar,2-hour postprandial blood sugar and safety index were compared and analyzed before and after the treatment.Results:1.In this study,a total of 75 patients who met the diagnosis of Chinese and Western medicine were included,of which a total of 72 patients completed clinical observation.2patients in the test group fell off and 1 in the control group,with an overall fall-off rate of4.0%.2.Baseline data: There were no statistically significant differences(P > 0.05)between the two groups in terms of age,gender,culture and education,duration of diabetes,TCM syndrome score,Diabetic Patient Quality of Survival Specific Scale score,stool trait score,fasting blood glucose and 2-hour postprandial blood glucose before treatment,which were comparable.3.Chinese medicine symptoms:(1)Total efficacy of Chinese medicine symptoms: after 2weeks of treatment,the total effective rate of the test group was 94.4% and that of the control group was 77.8%,and the test group was better than the control group in terms of the improvement of patients’ symptoms(P < 0.05);(2)Total points of Chinese medicine symptoms: after 2 weeks of treatment,the total points of Chinese medicine symptoms in both groups improved compared with those before treatment(P < 0.05),and the test group The difference was statistically significant(P < 0.05);(3)After 2 weeks of treatment,the points of all TCM symptoms in both groups were lower than those before treatment(P < 0.05),and the test group was lower than the control group in improving the points of "diarrhea,bloating and abdominal pain,fullness in the abdomen and stomach,and coldness in the extremities"(P <0.05),and the test group was lower than the control group in improving the points of "diarrhea,bloating and abdominal pain"(P < 0.05).There was no statistically significant difference between the two groups in the three scores of "bowel movements,thirst and loss of appetite" after treatment(P > 0.05).4.Stool character scores: After 2 weeks of treatment,the stool character scores of both groups were lower than before treatment(P < 0.05),and the test group was better than the control group,indicating that the difference was statistically significant(P < 0.05).5.Diabetic patients’ survival quality specific scale scores:(1)total scale scores: after 2weeks of treatment,the total DSQL scale scores of both groups were lower than before treatment(P < 0.01),and the test group was lower than the control group(P < 0.05);(2)each scale score: after 2 weeks of treatment,the scores of both groups in physical function,psychological/mental and treatment dimensions were lower than before treatment(P < 0.05),and after treatment In the three scores of physical function,psychological/spiritual and treatment dimensions,the test group was lower than the control group(P < 0.05),while in the social relationship dimensions the difference between the two groups was not statistically significant(P > 0.05).6.In terms of blood glucose: after 2 weeks of treatment,fasting blood glucose and 2-hour postprandial blood glucose in both groups were lower than before treatment(P < 0.01);after treatment,there was no statistically significant difference between the two groups in terms of fasting blood glucose(P > 0.05),while in terms of 2-hour postprandial blood glucose,the test group was significantly lower than the control group(P < 0.05),indicating that the test group had an advantage in improving postprandial blood glucose This indicates that the test group has an advantage in improving postprandial blood glucose.7.Safety: No adverse events occurred during the clinical treatment in both groups,and no significant abnormal changes were observed in the safety indexes such as vital signs,three major routine + fecal occult blood test,liver and kidney function,electrocardiogram and gastrointestinal ultrasound before and after treatment.Conclusions:Shuxie No.8 Decoction is effective in treating cold and dampness trapped spleen type diabetes mellitus combined with diarrhea,which can effectively reduce clinical symptoms such as diarrhea,bloating,abdominal pain,fullness in the abdomen,coldness in the extremities,while improving patients’ quality of life,improving stool properties,and relieving patients’ postprandial blood glucose with no significant adverse effects. |
PDF Full Text Request