Clinical Study Of Fuzheng Xiaoying Recipe In The Treatment Of Hashimoto's Thyroiditis (HT)

Objective:Hashimoto's thyroiditis(HT)is an organ-specific autoimmune disease.The current problem of this disease is to reducie the level of thyroid antibody,goiter and long treatment time,and there is still a lack of effective drugs to improve the immune function.This study aims to evaluate the efficacy and safety of Fuzheng Xiaoying recipe improving immune function,goiter nodules,and TCM syndromes of HT patients through standardized clinical trials,which is of positive significance for improving the diagnosis and treatment of HT with TCM and giving full play to the advantages of TCM in the treatment of autoimmune diseases.Methods:The randomized controlled clinical study was conducted on 140 patients who were admitted to the department of surgery of TCM of China-Japan friendship hospital from December 2016 to January 2019 and met the diagnostic criteria and inclusion criteria for HT of qixutanning syndrome.According to the random number table method,patients is divided into experimental group and control group.Experimental group were given Fuzheng Xiaoying recipe,daily water decoction of about 200 ml,points twice after meal half an hour in the morning and evening.For patients with hyperthyroidism,MMI was added on the basis of Chinese prescription,or for patients with hypothyroidism,L-T4 was added.The control group was treated with selenium 100ug qd.Patients with hyperthyroidism were treated with MMI on the basis of selenium,or patients with hypothyroidism were added with L-T4.After 3 months of treatment,thyroid function,thyroid antibody,T,B lymphocyte subsets and NK cell,thyroid imaging changes,TCM syndromes changes and blood routine,and liver and kidney function changes were compared between the two groupsResults:(1)There was no significant difference in gender,age,course of disease and degree of goiter between the two groups(P>0.05).(2)Comparison of thyroid antibody:After treatment,TPOAb and TGAb levels in the experimental group were significantly lower than those before treatment(P<0.05),and the reduction degree was better than that in the control group(P<0.05).(3)Comparison of thyroid size:After treatment,the thickness of the left and right thyroid lobes in the experimental group decreased significantly compared with that before treatment(P<0.05),and the thickness of the left thyroid lobe decreased significantly more than that in the control group(P<0.05).(4)Comparison of the degree of goiter:The degree of diffuse goiter in the experimental group was significantly reduced after treatment compared with before treatment(P<0.05).There was no significant difference in the degree of goiter before and after treatment in the control group.(5)Comparison of lymphocyte subsets:There was no statistical difference in T and B lymphocyte subsets and NK cell indexes between the two groups before and after treatment.(6)Comparison of TCM syndrome points:After treatment,the TCM syndrome points in the experimental group were significantly lower than before treatment(P<0.01),and the improvement of symptoms in the experimental group was significantly better than that in the control group(P<0.01).(7)Correlation analysis of thyroid function status and thyroid antibody:TPOAb levels were different with thyroid function status,and in patients with hyperthyroidism were significantly higher than those with normal thyroid function or hypothyroidism(P<0.05).(8)Correlation analysis of thyroid antibody and thyroid gland lobe size:TPOAb level is positively correlated with the thickness of left lobe,right lobe and isthmus of thyroid gland.There was a positive correlation between TGAb level and right lobe thickness o f thyroid,but the correlation was weak(r<0.3).(9)Comparison of safety indicators:Before and after treatment,blood routine,liver and kidney function,electrocardiogram and other indicators in the two groups were within the normal range,and there no adverse events occurred.Conclusion:Fuzheng Xiaoying recipe is superior to selenium yeast tablet in reducing the level of thyroid antibody,reducing the degree of goiter and improving the symptoms in HT patients,and has no adverse effect on blood routine and liver and kidney functions.Fuzheng Xiaoying recipe has a good effect of improving immune function and inhibiting goiter in the treatment of HT,and has a safety.