| Objective:To explore the clinical effectiveness and safety of the internal and external treatment of traditional Chinese medicine(TCM)for the liver depression and spleen deficiency type of Hashimoto’s thyroiditis with hypothyroidism.Method:It was a prospective observational clinical study.According to the inclusion and exclusion criteria,a total of 94 patients with Hashimoto’s thyroiditis combined with hypothyroidism were included,and 2 patients fell off.All the patients were treated by the Qinggan Jianpi Liqi internal and external treatment of TCM combined with Euthyrox for 84 days.During the observing periods,the day of enrollment,28th,56th and 84th were the times of visit.Thyroid hormone levels,the Euthyrox dosage,thyroid autoantibody titers,thyroid volume,blood routine,liver function,and kidney function were the observation indicators.To explore the clinical effectiveness and safety of TCM internal and external combined treatment of the liver depression and spleen deficiency type of Hashimoto’s thyroiditis with hypothyroidism.Results:TSH level and Euthyrox doseComparison of TSH levels at each visit point before and after intervention:the Mauchly spherical test from the single set of repeated measurement data analysis of variance illustrated that:this data was non-spherical distribution(p≤0.05).The statistical results after the Greenhouse-Geisser correction for degrees of freedom showed that:F=12.027 andp=0.001.It demonstrated that the average TSH level of all the subjects at each visit point varied a lot and showed an overall downward trend with significant statistical differences.Comparison of the Euthyrox dose at each visit point before and after intervention:the Mauchly spherical test from the single set of repeated measurement data analysis of variance illustrated that the data was non-spherical distribution(p<0.05).The statistical results after the Greenhouse-Geisser correction for degrees of freedom showed:F=63.867,p=0.000.It demonstrated that the average Euthyrox dose of all the subjects at each visit point varied a lot,and showed an gradual downward trend with significant statistical differences.TPOAb,TGAb titerComparison of the TPOAb titer at each visit point before and after intervention:the Mauchly spherical test from the single set of repeated measurement data analysis of variance illustrated that the data was non-spherical distribution(p<0.05).The statistical results after the Greenhouse-Geisser correction for degrees of freedom showed:F=32.120,p=0.000.It demonstrated that the average TPOAb titer of all the subjects at each visit point varied a lot,and showed an gradual downward trend with significant statistical differences.Comparison of the TGAb titer at each visit point before and after intervention:the Mauchly spherical test from the single set of repeated measurement data analysis of variance illustrated that the data was non-spherical distribution(p≤0.05).The statistical results after the Greenhouse-Geisser correction for degrees of freedom showed:F=26.960,p=0.000.It demonstrated that the average TGAb titer of all the subj ects at each visit point varied a lot,and showed an gradual downward trend with significant statistical differences.Thyroid volumeThe results of thyroid volume comparison before and after the intervention showed that the degree of enlarged thyroid volume after the treatment was significantly reduced compared with before:p=0.000,the difference was statistically significant.Safety evaluationThere were no obvious abnormalities in the subjects’ blood routine,liver function and kidney function indexes before and after intervention.2 subjects,one on the 7th and one on 26th,had a red skin scattered with small rashes around the neck and felt itchy.It subsided spontaneously without special treatment,Conclusion:This study suggested that:(1)The effectiveness of internal and external treatment of TCM in restore the thyroid function of Hashimoto’s thyroiditis with hypothyroidism,and gradually reduce the dosage of Euthyrox while maintaining stable thyroid function.(2)The internal and external treatment of TCM is effective in sustainability and stability reducing the TPOAb and TGAb titers of patients with Hashimoto’s thyroiditis and hypothyroidism. |