| Objective:To investigate the long-term clinical effects of XieHuoXiaoYing formula combined with Methimazole in the treatment of Graves hyperthyroidism patients in the early stage with heart and liver fire flaming syndrome and evaluate its therapeutic safety.Methods:All of the patients were enrolled into the study from 2015-2016 according to inclusion and exclusion criteria.All of the patients were from Nanjing University of Chinese Medicine Affiliated Hospital of integrated traditional Chinese and Western medicine,who were all meeting with the diagnostic criteria of early stage of Graves hyperthyroidism and heart and liver fire flaming syndrome.According to random number table method,patients were randomly divided into two groups:control group and treatment group.Patients in control group were treated with Methimazole 10-30mg/d and gradually reduced Methimazole to partial discontinuation or small dosage to maintain.Patients in treatment group were treated with Methimazole combined with XieHuoXiaoYing formula,1 agent daily,twice a day.4 weeks is a course and take Chinese traditional medicine for 3 courses.The recovery of the two groups was observed at 0,3,6,12 month.Results:Finally,34 patients in control group and 34 patients in treatment group finished the study.The sex and age of two groups were comparable before treatment(P>0.05).There were no significant differences in Free Triiodothyronine(FT3),Free Thyroxine(FT4),Thyroid Stimulating Hormone(TSH)and Antibodies Against TSH Receptor levels(TRAb)between two groups before treatment(P>0.05).After treatment,TSH levels were significantly higher and FT3,FT4,TRAb levels were significantly lower and there were significant differences(P<0.01).There were no significant differences in TSH levels in 3,6,12 month after treatment between the two groups(P>0.05).FT3,FT4 levels of treatment group were obviously lower than that of control group in 3,6,12 month after treatment and the differences were statistical(P<0.05,P<0.01,P<0.01,P<0.05,P<0.05,P<0.05).There were no significant differences in TRAb levels in 3,6 month after treatment between the two groups(P>0.05)but the TRAb levels of treatment group were lower than control group in 12 month after treatment(P<0.05).There were no significant differences in thyroid volume and the peak systolic velocity(PSV)between the two groups before treatment(P>0.05).The thyroid volume was obviously smaller and the PSV was reduced after treatment which had significant differences compared with pretreatment(P<0.01).Compared between groups,the thyroid volume of treatment group was obviously smaller than control group and the PSV was reduced after 12 months’ treatment(P<0.05).Compared between groups,the dosage of Methimazole for treatment group was less than control group after 3 months’ treatment with a statistical difference(P<0.05).There was no significant difference in the dosage between the two groups after 12 months’ treatment(P>0.05).In addition,the recovery time of FT3 and FT4 in treatment group was significantly shorter than control group(P<0.05).The adverse events of treatment group were less than control group but there was no statistical difference(P>0.05).Conclusions:XieHuoXiaoYing formula combined with Methimazole had significant effect in the treatment of Graves hyperthyroidism patients in the early stage with heart and liver fire flaming syndrome.It can effectively decrease the thyroid hormone level,decrease the TRAb level,shorten the recovery time of FT3 and FT4,shrunken the thyroid volume and the PSV.It can also significantly reduce the dosage of Methimazole in the early treatment of Graves hyperthyroidism. |