Clinical Research On Shenmai Xiabei Decoction To Interfere In The Syndrome Of Deficiency Of Qi Abd Yin, Mutual Blockage Of Liver Fire And Phlegm Stagnation In Hashimoto Hyperthyroidism

Objective:To study the chemopreventive therapeutic effects of ShenMaixiabei decoction in treating hashimoto hyperthyroidism of both Qi and Yin deficiency and Phlegm stasis syndromes in patients with TCM, which can be reflected by TCM syndrome integral, heart rate, body weight, the level of thyroid hormone (TT3, TT4, FT3, FT4, TSH), TGAb, TMAb, IL-6, TNF-alpha, the size of thyroid gland. To evaluate the clinical efficacy and safety so as to provide objective basis for clinical application.Methods:Collecting the data of patients from Nanjing University of Chinese Medicine Department of Endocrinology Affiliated Hospital surgery clinical during 2013-2015. According to the disease diagnostic criteria,60 patients were selected and divided into 2 groups in random, namely treatment group and control group, with 30 patients in each group. Conventional Western medical treatment contains basic treatment and anti thyroid drugs in small doses, such as race (methimazole).If the patient has rapid heart rate,we can also use propranolol. Treatment group contains both conventional treatment of Western Medicine and ShenMaixiabei decoction throughout the treatment. The specific prescriptions are as follows:Boiling the herbals with water for over 30 minites,2 times a day orally. Two groups:every 4 weeks for 1 course,3 courses were observed.Results:The thyroid hormone level of patients in the two groups before treatment were comparable (P>0.05). The level of TT3, TT4, FT3, FT4, TSH were significantly improved (P＜0.01) after treatment in both groups. The level of TT3, TT4, FT4, TSH in the treatment group had a higher incidence of improvement than the control group (P<0.05).The level of FT3 in treatment group improved significantly compared to the control group (P＜0.01). Before treatment, the thyroid hormone related antibody level in 2 groups were no obvious differences (P>0.05), which means they were comparable. The level of TMAb, TGAb in treatment group were decreased significantly after intervention (P<0.05). TGAb level in the control group were decreased after intervention (P<0.05). The level of TMAb, TGAb in the treatment group had a higher incidence of improvement than the control group (P<0.05). Two groups of patients with IL-6 and TNF-alpha had no significant difference before treatment (P>0.05), which means they were comparable. The level of IL-6 and TNF-alpha in treatment group were decreased significantly after intervention (P<0.05). The level of IL-6,TNF-alpha in the control group had no significant difference after treatment. The level of IL-6,TNF-alpha in the treatment group had a higher incidence of improvement than the control group (P<0.05). Heart rate of two groups of patients before treatment had no significant difference (P>0.05),which means they were comparable. Two groups were obviously improved and the difference was statistically significant after intervention (P＜0.05 or P＜0.01). The heart rate in the treatment group had a higher incidence of improvement than the control group and the difference was statistically significant (P＜0.05). The weight of the two groups of patients had no significant difference before treatment (P>0.05), which means they were comparable. In the treatment group the body weight increased significantly (P＜0.05),so as the control group (P<0.05). The body weight in the treatment group had a higher incidence of improvement than the control group and the difference was statistically significant (P＜0.05). The size of thyroid gland get smaller after treatment in both groups.4 cases of the treatment group converted first degree to no goiter, which indicated significant differences (P<0.05).4 cases converted second degree to first degree,1 case of third degree converted to second degree goiter. The convertion from first degree to no goiter in the treatment group had a higher incidence of improvement than the control group and the difference was statistically significant (P＜0.05). The treatment group of 30 cases had 1 case of clinical cure (3.33%),8 cases cured (26.67%),19 cases effective (63.33%),2 cases invalid (6.67%).The total efficiency is 93.33%.30 cases of the control group had 0 clinical cure (0%),2 cases cured (6.67%),18 cases effective (60%), 10 cases invalid (33.33%).The total efficiency is 67.67%. The total effective rate of treatment group was superior to the control group, which indicated significant difference (P<0.01) Through the two groups of patients with syndrome integral comparison, The symptoms in two groups were significantly improved, the difference was statistically significant(P<0.05 or P <0.01).The treatment group had a higher incidence of improvement than the control group and there was statistically significant difference between the two groups (P＜0.05).30 cases in treatment group had 6 cases cured (20%),22 cases effective (73.33%),2 cases invalid (6.67%).The total efficiency is 93.33%.30 cases in the control group had 0 cured case (0%) 19 cases effective (63.33%),11 cases invalid (36.67%). The total efficiency is 63.33%. The treatment group had a higher incidence of improvement than the control group and there was statistically significant difference between the two groups (P<0.05). Safety:Troughtout the whole course of treatment in 60 patients,there is no obvious abnormality, no statistically significant difference (P>0.05) Conclusion:Through the preliminary clinical study, Shenmai Xiabei Decoction in the treatment of Hashimoto Hyperthyroidism of deficiency of qi and Yin, mutual blockage of liver fire and phlegm stagnation,in TCM syndrome, can significantly improve clinical symptoms; in western medicine indicators:can stabilize heart rate、gain weight、improve of thyroid hormone levels (TT3、TT4、FT3、FT4、TSH)、TGAb、TMAb、IL-6、TNF-α, alleviate the goiter.Meanwhile,it does not have damage to liver and kidney function, It is safe and effective has a broad prospect of application.