| Objective:To observe the clinical efficacy and safety of Yiqi Xiaoyin Decoction in the treatment of Hashimoto's thyroiditis(qi deficiency type)with normal thyroid hormone levels.Methods: From December 2017 to January 2019,120 patients with Hashimoto's thyroiditis who had normal thyroid hormone levels in the outpatient or inpatient hospitals of the third affiliated Hospital of Yunnan University of traditional Chinese Medicine and with qi deficiency were collected.They were randomliy divided into a blank controled group,a western medicine control group and a TCM treatment group.The blank control group received no special treatment and was only followed up.The western medicine control group was given selenium yeast tablets,100 ug each time,twice a day.The traditional Chinese medicine treatment group was given “ Yiqi Xiaoyin Decoction” granules,one dose per day,taken in three times.Treatment for12 weeks.The main observations were compared with the changes of TCM syndrome scores of qi deficiency syndrome before and after treatment,thyroid TGAb and TMAb titer levels.Secondly,the changes of thyroid hormones TSH,FT3,FT4 levels and thyroid ultrasound imaging changes(thyroid size,echo,cervical lymph nodes)were observed,monitoring safety indicators liver and kidney function,three major routines.Results: 1.A total of 120 cases were included in the study.A total of 17 cases were absent.The effective number was 103 cases,including 34 cases of blank control group,34 cases of western medicine control group and 35 cases of traditional Chinese medicine treatment group.The gender,ages and durations of treatment were compearable before the treatment(p>0.05).2.TCM symptoms analyisis: After treatment,the scores of TCM syndromes in all three groups were decreased(p<0.05),swelling of the anterior neck of the neck,discomfort in the neck,shortness of breath,fatigue,fatigue,spontaneous sweating,lazy words and other symptoms of traditional Chinese medicine The improvement in the treatment group was more pronounced(p < 0.01).Compared with the curesative effect of TCM syndrome scores,the total effecitives rate of the TCM treatment group was 88.57%,the total effeictive rate of the western medicine contirol group was70.59%,and the total effecitive rate of the blanek control group was 26.47%.The three groups of TCM were statistically different(p<0.05).3.Analysis of thyroid antibody titer levels: After treatment,there was no difference in the TGAB group before and after treatment(p>0.05).There were significant differences in TGAB and TMAB titers between the two groups before and after treatment(p<0.05).The levels of TGAB titers in the Chinese medicine treatment group and the western medicine control group were all decreased,and the reduction of the traditional Chinese medicine control group was more significant(p<0.05).The TMAB titers of the three groups were lower than those before treatment,and the Chinese medicine treatment group decreased.The most significant(p<0.05),but there was no significant difference between the western medicine control group and the blank control group(p>0.05).4.Analysis of thyroid function: After treatment,there was no significant change in TSH,FT3 and FT4 before and after treatment with thyroid hormone levels(p>0.05).5.Analysis of thyroid volume change: After treatment,the average thyroid volume of the Chinese medicine treatment group was reduced(p<0.05),and the difference of thyroid volume between the blank control group and the western medicine control group was not significant(p>0.05).6.Analysis of thyroid echo and cervical lymph nodes: There was no significant difference in the detection rate of thyroid grid echo and cervical lymph nodes before and after treatment(p>0.05).The detection rate of cervical lymph nodes was 82.35%in the blank control group,76.47% in the western medicine control group,and82.85% in the Chinese medicine treatment group.7.Overall efficacy analysis: 8 cases were effective in the blank control group,the total effective rate was 23.52%;5 cases were effective in the western medicine control group,17 cases were effective,12 cases were ineffective,and the total effective rate was 64.70%;8 cases were effective in the Chinese medicine treatment group,21 cases were effective Invalid 6 cases,the total effective rate is 82.85%.There was a statistically significant difference in the total effective rate between the three groups(p<0.05).8.Safety analysis: During the experimental research,no obvious abnormalities were found in the three groups of safety indicators.Three groups of liver function and renal function related tests showed no significant abnormalities before and after treatment(p>0.05),and no adverse events occurred.Conclusion: Yiqi Xiaoyin Decoction can improve the symptoms of patients with qi deficiency type Hashimoto's thyroiditis,reduce the level of thyroid autoantibody titer,improve the diffuse goiter of Hashimoto patients,reduce the volume of thyroid,and its therapeutic effect is better than that of selenium yeast;The detection rate of echo and cervical lymph nodes had no significant effect;it did not affect the thyroid hormone level,safe and effective,and no adverse reactions. |
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