| Objective: In this study,the Qigui Kaiyu Prescription was used to treat hypothyroidism combined with depression caused by Hashimoto’s thyroiditis with syndrome of Yang deficiency phlegm stasis type and the effects on inflammatory markers interleukin-1β(IL-1β)and interleukin-6(IL-6).Objective evaluation of its clinical efficacy,to provide a clinical basis for TCM treatment of the disease,and to preliminarily explore its possible mechanism of action.Methods: Sixty patients with hypothyroidism associated with depression due to Hashimoto’s thyroiditis were selected and randomly divided into control group(n = 30)and observation group(n= 30).The control group was given the medicine levothyroxine sodium tablet(raitis)orally in addition to the basic treatment such as health promotion and education,and the observation group was additively given the self-designed prescription of traditional Chinese medicine decoction-Qigui Kaiyu prescription(200ml,one dose per day)orally.The two groups were observed for 12 consecutive weeks(a total of 3 courses,with 4 weeks as a course of treatment).By comparing the thyroid function(FT4,TSH),the contents of thyroid peroxidase antibody(TPOAb)and thyroglobulin antibody(TGAb),the changes of inflammatory cytokines IL-1 β and IL-6,the improvement degree of TCM syndromes curative effect and the score of Hamilton Depression Scale before and after treatment between the observation group and the control group,the difference of L-T4 dose between the two groups at the end of each course of treatment was compared,and the above data were statistically analyzed,the safety indicators of the two groups of patients were detected before and after treatment.Results:(1)As for the clinical efficacy,the clinical efficacy of the observation group showed that the effective rate was 86.67%,which was significantly higher than the total effective rate of 63.33% in the control group,and the comparison of the total effective rate between the two groups had significant statistical significance(P<0.05).(2)Comparison of TCM syndrome efficacy and integral: after treatment,the total effective rate of the observation group was 90.00%,while the total effective rate of the control group was 66.67%,P<0.05 by statistical comparison.On the TCM syndrome integral,the observation group and control group after treatment and treatment of integral comparison before all showed a trend of decrease,P < 0.01,however,according to data,observation group after treatment of TCM syndrome integral decline more significantly than the control group(P < 0.01),the comparison of the above data are suggested by significant statistical significance,the difference was comparable.(3)About the score of Hamilton Depression Scale: after treatment,the HAMD score of both the observation group and the control group decreased compared with before treatment(P<0.01),and the decrease level of the observation group was more obvious(P<0.01).(4)As for the comparison of thyroid function,the levels of FT4 in the two groups were significantly increased after treatment and basically reached the normal level(P<0.01).The TSH in the two groups was also significantly improved and decreased to different degrees compared with that before treatment(P<0.01).According to the comparison of thyroid function between the two groups at the end of each course of treatment,the increase of FT4 levels and the decrease of TSH levels in the observation group were better than those in the control group at the end of each course of treatment,and the observation group had better control(P<0.01).(5)As for the comparison of thyroid peroxidase antibody and thyroglobulin antibody,the contents of TPOAb and TGAB in 2 groups were significantly decreased after treatment compared with before treatment,with statistical comparison P<0.01;The decrease degree of observation group was more obvious(P<0.05).(6)Comparison of IL-1β and IL-6 levels: The comparison of IL-1βand IL-6 levels between the two groups after treatment and before treatment showed a significant difference(P<0.01),while the decrease of observation group after treatment was more obvious than that of control group(P<0.05).(7)L-T4 dosage: the dosage of L-T4 in the observation group at the end of each course of treatment was lower than that in the control group during the same course of treatment(P<0.05).(8)Safety analysis:During the 12-week(3 courses)treatment,the vital signs of patients in the two groups were stable,and no obvious abnormal safety indicators were found.During the treatment period,no adverse reactions,allergies and other side effects were reported in the observation group and the treatment group.Conclusion: The clinical observation of qigui kaiyu prescription combined with levothyroxine(raitis)in the treatment of hypothyroidism and depression caused by Hashimoto’s thyroiditis with Yang deficiency phlegm stasis type howed that the combination of traditional Chinese and western medicine had a significant clinical effect.It has obvious advantages in improving patients’ depression state,improving thyroid function and reducing thyroid antibody level.It is speculated that the mechanism may be through reducing serum IL-1β,IL-6 levels,improve the body inflammatory response of patients.This scheme is safe,effective and has no adverse side effects,which is worthy of further study. |
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