Evaluation of the Therapeutic Effect of Bushen Runzao Fang(补肾润燥方)on Primary Sj?gren's Syndrome Based on Salivary Gland Ultrasound
Objective:To evaluate the clinical efficacy of Bushen Runzao Fang(补肾润燥方)in treating primary Sjögren's syndrome with liver kidney yin deficiency involving the salivary glands using salivary gland ultrasound technology,and to explore the role of salivary gland ultrasound technology in evaluating the efficacy of traditional Chinese medicine in treating primary Sjögren's syndrome.Methods:Seventy-eight patients with primary Sjögren's syndrome were randomly divided into a treatment group and a control group,with thirty-nine cases in each.The control group was given hydroxychloroquine sulfate,while the treatment group was treated with Bushen Runzao Fang based on the treatment like that for the control group.The treatment course for both groups is 12 weeks.The ESSDAI score,TCM syndrome score,ultrasound semi quantitative grading,and shear wave elastic modulus before and after treatment in both groups were observed.Results:One case fell out of each group,and 38 cases were ultimately included in each.After treatment,the ESSDAI scores of both groups decreased compared to before treatment(P<0.05);and the degree of decline in the treatment group was better than that in the control group(P<0.05).In the treatment group,no cases were clinically cured,10 cases showed significant improvement,25 cases were effective,and 3 cases were ineffective,with a total effective rate of 92.10%;in the control group,there were no cases clinically cured,3 cases showed significant improvement,25 cases were effective,and 10 cases were ineffective,with a total effective rate of 73.68%.The difference between the two groups was statistically significant(P<0.05).After treatment,salivary gland ultrasound semi quantitative grading of both groups showed improvement,with an improvement rate of 73.68%in the treatment group and 47.37%in the control group(P<0.05);the shear wave elastic modulus of four glands in both groups decreased compared to before treatment(P<0.05),and the degree of decrease in the treatment group was better than that in the control group(P<0.05).Conclusion:Bushen Runzao Fang has a definite therapeutic effect on patients of primary Sjögren's syndrome with liver kidney yin deficiency type involving the salivary glands.Salivary gland ultrasound can assist in evaluating the efficacy of traditional Chinese medicine in the treatment of primary Sjögren's syndrome.