| Objective: This project aims to provide a new objective basis for the clinical application of Juanbi Granule in Wangbi patients with Wangbi syndrome of cold dampness by observing the effect of Juanbi Granule on nail microcirculation,and to further explore the effectiveness and safety of Juanbi Granule in the treatment of Wangbi syndrome of cold dampness.Methods: In this study,we collected Wangbi patients who went to the outpatient department and inpatient department of the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine in January 2020.According to the random number table,the patients were randomly divided into the control group and the experimental group.The two groups were treated with methotrexate tablets,and the experimental group was additively treated with Juanbi Granules.Each patient was enrolled according to the random number table according to the order of treatment.The patients were treated for 8 weeks,and the evaluation of TCM disease efficacy,comparison of ACR20 standard and nail fold microcirculation detection and other indicators were compared respectively.The relevant data were statistically analyzed and the comprehensive efficacy was evaluated.Results: Up to January 2021,a total of 63 patients with Wangbi were enrolled,including 32 in the treatment group and 31 in the control group.After 8 weeks of treatment,the comparative analysis of return visit results showed that:1.Evaluation of TCM disease efficacy: the total effective rate of the treatment group was 84.37%;The total effective rate of the control group was 61.29%.It shows that both the treatment group and the control group have curative effect on Wangbi syndrome.The comparison between the two groups shows that the treatment group is better than the control group,and the difference is statistically significant(P<0.0001).2.ACR20 standard compliance rate: the compliance rate of the treatment group was87.50%;The standard rate of control group was 64.52%.This indicates that the drugs used in both the treatment group and the control group can relieve the condition of the patients with Wangbi.The comparison between the two groups shows that the treatment group is better than the control group,the difference is statistically significant(P<0.05).3.Treatment in both groups could improve TCM syndrome score,joint swelling,pain,morning stiffness,tenderness,joint function,DAS28 disease activity,erythrocytic sedimentation rate,C-reactive protein,etc.,and the treatment group was better than the control group,the difference was statistically significant(P < 0.05).4.Comprehensive judgment of nail fold microcirculation: in the treatment group,there were 29 cases with mild abnormality,accounting for 90.30%,and 3 cases with moderate abnormality,accounting for 9.70%.After treatment,3 cases(9.38%)were normal,24 cases(75.00%)were generally normal,and 5 cases(15.63%)were mildly abnormal.In the control group,there were 28 cases with mild abnormality(90.60%)and 3 cases with moderate abnormality(9.40%).After treatment,1 case(3.23%)was normal,14 cases(45.16%)were roughly normal,14 cases(45.16%)were mild abnormal,and 2 cases(6.45%)were moderate abnormal.This indicated that both Juanbi granule group and control group could improve the nail fold microcirculation of Wangbi patients,but Juanbi granule group was better than control group in improving the nail fold microcirculation,with statistical significance(P<0.05).5.There was no statistical significance in the safety indexes of 2 groups before and after treatment(P>0.05).Conclusion:1.Juanbi Granule can improve the nailfold microcirculation of Wangbi patients with Wangbi syndrome of cold and dampness,and the detection of nailfold microcirculation can also be used as a new objective basis for the treatment of Wangbi syndrome of cold and dampness by Juanbi Granule.2.Juanbi Granules can improve the clinical symptoms of joint swelling,joint tenderness and joint stiffness in the morning of Wangbi patients.3.Juanbi granules can significantly improve the inflammatory indexes such as erythrocyte sedimentation rate and C-reactive protein in Wangbi patients with Wangbi syndrome.4.The clinical study also confirmed that Juanbi Granule is an effective and safe drug for the treatment of WP syndrome of cold and dampness,which can be further applied and promoted in clinical practice. |
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