| Objective:Humoral immunity mediated by antibodies is related to the immune damage process of hashimoto thyroiditis(HT),traditional Chinese medicine(TCM)is often used in the treatment of hashimoto’s thyroiditis,but lack of high quality clinical research.this study through the strict design of randomized blinded prospective clinical study,the evaluation of traditional Chinese medicine chaihuxuanfuhua decoction taintervention hashimoto thyroiditis immune damage process and improve the clinical curative effect of quality of life.Method:This study is a randomized,double-blind,prospective controlled trial.Fifty participants diagnosed with hashimoto’s thyroiditis with hypothyroidism were randomly assigned to either the experimental group(levothyroxine with herbal medicine)or the control group(levothyroxine with placebo)in a ratio of 1:1 Participants will be treated for eight weeks and followed up for 24 weeks,Observe the changes of TPOAb、TGAb、thyroid function、thyroid ultrasound、TCM symptom score、depression and anxiety score,quality of life score and dose of levothyroxine before and after treatment for 24 weeks.Result:(1)Before treatment,there was no significant difference in baseline data and observational indicators between the two groups(P>0.05).After 8 weeks of treatment and 24 weeks of follow-up,thyroid peroxide antibodies and thyroglobulin antibodies decreased in both groups(P<0.05),and the degree of decline in the test group was significantly better than that in the control group(P<0.01 or P<0.05);(2)After 8 weeks of treatment,the levels of TSH in the two groups decreased(P<0.05),and the reduction in the experimental group was more significant than that in the control group(P<0.05).During the follow-up for 24 weeks,it was found that the mean TSH in the experimental group decreased to a normal level,and the degree of decline was significantly different from that in the control group(P<0.05);the FT3 and FT4 levels in the two groups increased after 8 weeks of treatment and 24 weeks of follow-up(P<0.05),there is no significant difference in the level of improvement between the two groups(P>0.05);(3)After 8 weeks of treatment and 24 weeks of follow-up,there was no statistical difference between the long and short axis diameters of the left and right thyroid lobe of the two groups(P>0.05),and there was no statistical difference in the degree of diameter reduction between the two groups(P>0.05).The thickness of the isthmus was not statistically different between the two groups(P>0.05).Although the test group was significantly lower than before treatment(P<0.05 or P<0.01),there was no statistical difference between the two groups(P>0.05);(4)The clinical symptom scores of both groups decreased after treatment for 8 weeks.The experimental group had statistical significance(P<0.01),while the control group had no statistical significance(P>0.05).Follow-up for 24 weeks,the clinical symptom scores of the two groups The comparison was statistically significant(P<0.05).Compared with the two groups,the degree of decline in clinical symptom scores in the experimental group was significantly better than that in the control group(P<0.01);(5)After 8 weeks of treatment and 24 weeks of follow-up,the depression and anxiety scores of both groups were lower than before treatment(P<0.01),and the degree of decline in the experimental group was significantly better than that in the control group(P<0.01);(6)After 8 weeks of treatment and 24 weeks of follow-up,quality of life scores were improved in both groups(P<0.05),and the degree of improvement in physical and psychological scores in the test group was significantly better than that in the control group(P<0.05 or P<0.01)Social and environmental scores,the improvement in the experimental group was not statistically different from the control group(P>0.05);(7)After 8 weeks of treatment,the doses of levothyroxine in both groups were reduced(P<0.05),and there was no significant difference between the two groups(P>0.05)After 24 weeks of follow-up,it was found that the test group had a significantly lower dose than the control group(P<0.05),and two subjects could stop taking levothyroxine with normal nail function and no physical discomfort;(8)After treatment,the clinical effective rate was 75%(18/24)in the experimental group and 46%(11/24)in the control group.The experimental group was significantly better than the control group(P<0.05).Conclusion:Chaihu Xuanfuhua Decoction can effectively interfere with the course of Hashimoto’s thyroiditis immune injury by reducing thyroid antibody titers,alleviate clinical discomfort and emotional disorders,and improve patients’ health-related quality of life. |
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