Clinical Efficacy Of Balgham Mixture In The Treatment Of Astringent Mucinous Type Rheumatoid Arthritis And Its Quality Standard Study

Objective:To observe the efficacy and safety of Balgham Mixture in the treatment of astringent mucinous rheumatoid arthritis and to improve its quality standards.Methods:1.51 patients with rheumatoid arthritis who attended the internal medicine and orthopedics outpatient clinics of the Autonomous Region Uyghur Medical Hospital（Second People’s Hospital of the Autonomous Region）from January 2020 to February2023 and met the requirements were randomly divided into control and treatment groups according to the Uyghur Medicine abnormal body fluid quality typing criteria.Patients in the control group were given Surunjan tablets（MZJ-W-0064-2013,specification:0.52g/tablet）,3-5 tablets orally each time,three times daily for 10 days,Exorcise cold and heatiness root decoction（in-hospital preparation of the Autonomous Region Uyghur Medical Hospital,specification:50m L/bag）,50m L orally each time,2 times daily for 10days,and Surunjan oil（Autonomous Region Uyghur Medical Hospital in-hospital preparation,specification:100m L/bottle）,an appropriate amount of which was applied to the affected area twice daily.Patients in the treatment group were given Balgham Mixture（Z20200034000,specification:500m L/bottle）,100 ml once,three times a day,for 7-9 days.in addition to the medication in the control group,The general condition,degree of joint pain,degree of joint swelling,degree of joint pressure and pain,degree of restricted mobility,morning stiffness,degree of joint deformity,tongue coating,tongue sign,pulse sign,total score of Uyghur medicine symptoms,DAS28 ESR,CRP,WBC,ALT,AST,Ur,Cr and other indexes were recorded before and after treatment in each group.Clinical effectiveness was assessed by reference to the American College of Rheumatology（ACR）recommendations for ACR20/50/70,and the trial procedure was carefully monitored.The results of all experiments were compared at the end of the trial and analyzed using SPSS25.0 statistical software.2.Quality standard enhancement of mucilage maturation agent:quantitative experiment based on the original thin-layer identification item（tentative determination of total flavonoid content by UV spectrophotometry and ammonium glycyrrhizate content by high performance liquid chromatography）.Results:1.When comparing the two groups,except for the age difference,which was statistically significant（P<0.05）,other general data showed no statistical significance（P>0.05）.2.Clinical symptoms:Before diagnosis and treatment,there was no significant difference（P<0.05）in the joint pain,swelling,tenderness,limited mobility,and degree of joint deformity between the two groups of patients,indicating comparability.After treatment,the joint pain,swelling,tenderness,and limited mobility of the two groups of patients improved,and there was a statistically significant difference in the time difference between the two groups（P<0.05）.However,the improvement of the above symptoms in the treatment group was more significant than that in the control group after diagnosis and treatment.3.Other symptoms include increased drooling during sleep,shiny tongue,lack of taste when waking up in the morning,increased urine output,slightly white eyes,white urine color,and cold joints in some joints.There was no significant difference in other symptoms between the two groups of patients before treatment,which can be compared.After diagnosis and treatment,the relevant symptoms of the two groups of patients improved,and there was a statistically significant difference（P<0.05）when comparing them between groups.Although the relevant symptoms of the two groups of patients improved after diagnosis and treatment,the improvement in the treatment group was more significant,and there was statistical significance（P<0.05）when comparing them within the group.4.Acute phase reactants and safety indicators:The ESR levels of both groups of patients decreased after diagnosis and treatment,but the decrease in the treatment group was more significant than the control group,and there was a statistically significant difference（P<0.05）when comparing within the group.The difference in the reduction of ESR levels between the two groups of patients was not significant,so there was no statistically significant difference（P>0.05）when compared within the group after diagnosis and treatment.There was no significant change in CRP levels between the two groups of patients before and after diagnosis and treatment,and the difference was not statistically significant（P>0.05）.There was no significant change in biochemical indicators such as WBC,ALT,AST,Ur,Cr,etc.between the two groups of patients before and after treatment,and there was no statistically significant difference in time difference between the groups（P>0.05）.5.DAS28 value and grading:There was no significant difference in DAS28 values between the two groups of patients before treatment,indicating comparability.The DAS28 values of the two groups of patients began to decrease after diagnosis and treatment,and there was a statistically significant difference between the groups（P<0.05）.There was a statistically significant difference in DAS28 values between the two groups of patients during intra group comparison（P<0.05）,but the DAS28 decrease in the treatment group was greater than that in the control group.Comparison of DAS28 grading:Before treatment,both groups of patients had high DAS28 activity,and there was no significant difference in activity grading between the two groups,indicating comparability.After diagnosis and treatment,the activity grading of the control group patients did not show a significant decrease,but the activity of the treatment group patients significantly decreased.There was statistical significance in both inter group and intra group comparisons of the treatment group（P<0.001）.ACR:There was a statistically significant difference in VAS,PGA,DGA,and HAQ between the two groups of patients before treatment（P<0.05）.There was no statistically significant difference in Visual analogue scale,patients globa-assessment,and Health assessment questionnaire between the two groups of patients after treatment,while there was a statistically significant difference in doctors globa-assessment（P<0.05）.6.Comparison of tongue coating and tongue image:there was no statistically significant comparison between groups before treatment（P>0.05）;the rate of appearance of related symptoms decreased after treatment.Pulse:Statistically significant differences were found among the pre-treatment broad and fine-pulse groups（P<0.05）,And the statistical significance of broad and coarse slow pulse was compared（P<0.05）.Compared with the control group,the Uyghur medicine symptom score of the treatment group decreased more significantly,and the difference was statistically significant（P<0.05）.7.In the thin layer chromatography of the test article,there were identical spots on the corresponding positions of the licorice control herbs,which were consistent with the original quality standard;the linearity of ammonium glycyrrhizinate was good in the concentration range of 2.0μg-m L-1～12.0μg-m L^-1with R²=0.9999,The average spiked recovery was 101.63%,and the final determination was that the Balgham Mixture should contain not less than9.569 mg/bottle of ammonium glycyrrhizinate.Conclusions:1.When basal therapy was combined with Balgham Mixture for RA,patients had less severe symptoms such as joint pain,joint swelling,joint pressure,limitation of motion,and morning stiffness than the control group.2.The combination of basic therapy and mucus maturation significantly improved RA Uyghur medicine syndrome symptoms.3.The results of the Balgham Mixture quality standard elevated in this study are consistent with the requirements,reproducible and easy to operate.