Objectives:Evaluated the effect of Erxian Formula Decoction intervening the Hashimoto’s thyroiditis Patients, and explore the scientific and effectiveness of the " proband and conquer" theory applied in Hashimoto thyroiditis, which can open up new ideas for early prevention of Hashimoto’s thyroiditis.Methods:The study using the randomization and blank drugs medicine control method.114 Hashimoto’s thyroiditis patients from the department of endocrinology where from the first affiliated hospital of Xiamen university were randomly assigned into the treatment group (57 patients) and the control group (57 patients). Treatment group (57 cases) take Erxian formula decoction twice a day, morning and evening, for 12 weeks.57 cases in the control group does not give any medication, regular telephone follow-up.The changes of clinical symptoms and side effects were observed during the 12 weeks, The thyroid hormone levels,thyroid-associated antibody titers and thyroid size were measured,thyroid volume was calculate before and after the observation period. All data are used SPSS 17.0 statistical software for statistical analysis.Result:The study included 114 patients with a expulsion rate of 10.7%,of which 103 patients completed the clinical test,the treatment group lost 5 patients and the control group off the 6 case. There was no difference in sex, age, clinical symptoms and thyroid related indicators between both groups. The baseline datas were comparable. ①The thyroid hormone levels:Whether the serum TSH levels are normal or elevated, Erxian formula decoction could lower TSH levels, which are significantly better than the control group (P<0.01),and make TSH levels in subclinical hypothyroidism patients with Hashimoto’s thyroiditis near normal.②The thyroid-associated antibodies:This study shows that there is no significant statistical difference over the thyroid-associated antibodies changes (P> 0.05),except that the TGAb levels of the treatment group are fall down compared with the previous (P<0.05); there is also no difference between the two groups (P>0.05). ③The thyroid volume:After 12 weeks, the treatment group decrease thyroid volume than before, with a statistically significant difference (P<0.01), while the control group showed no significant difference (P>0.05). The thyroid volume of the treatment group decrease compared with the control group after the observation, there was statistically significant (P<0.01).④TCM symptoms:There is a significant improvement in symptom scores in tereatment group, that the total efficiency is 63.05%,while the control group is 8.51%.The treatment group many TCM symptoms improve than those in the control group.⑤Security:the security indicators, for example ALT, AST, CRE, BUN in both groups are all in the normal range.No serious adverse reactions were observed, there is no significant difference between groups (P>0.05).Conclulation:The Erxian Formula Decoction in improving the levels of serum TSH,thyroid volume, clinical symptoms are better than the control group in early Hashimoto’s thyroiditis patients.We find that there is a certain effect on shorting the course and slowing the development of hypothyroidism with Hashimoto’s thyroiditis, and confirme the correctness of the " proband and conquer" theory applied in Hashimoto’s thyroiditis, it is also safe, effective and without side effects. |