| Objective:To investigate the efficacy and safety of Shuganyuying Decoction combined with low-dose flupentixol and melitracen in treating postoperative DTC patients with anxiety and depression,which are identified by traditional Chinese medicine as liver-depression and qi-stagnation evidence.Methods:Sixty two patients diagnosed with differentiated thyroid cancer with anxious and depressed mood after surgery,which were identified by traditional Chinese medicine as liver-depression and qi-stagnation evidence,attending the Department of Endocrinology of Qingdao Hospital of Traditional Chinese Medicine were selected and randomly divided into control and treatment groups.Two cases were shed due to lost visits and other factors,and finally 30 cases in each group.Both groups were given TSH suppression treatment after DTC and flupentixol and melitracen tablets orally,and in the control group,conventional doses of flupentixol and melitracen were used,the treatment group used a small dose of flupentixol and melitracen with the addition of Shuganyuying Decoction together orally,and the duration of treatment was 4weeks in each group.The clinical efficacy and changes in anxiety and depression in each group were compared by the anxiety self-assessment scale(SAS)and depression self-assessment scale(SDS)score.The improvement of TCM symptoms in each group was compared by the recording of TCM evidence points.The side effects were recorded by the SERS Antidepressant Drug Side Effects Scale score.Thyrotropin(TSH),serum free triiodothyronine(FT3),and serum free thyroxine(FT4)were measured before and after treatment,and statistical analysis was performed to compare the changes in thyroid function of patients.Safety-related laboratory indices were monitored before and after treatment to evaluate the safety of Shuganyuying Decoction for clinical use.Results: 1.The comparison of SAS and SDS scores between the two groups before and after treatment was statistically significant(P<0.01).When comparing the SAS scores of the two groups before and after treatment,the treatment group was better than the control group,and the difference was statistically significant(P<0.01).When comparing the SDS scores of the two groups before and after treatment,the treatment group was better than the control group,and the difference was statistically significant(P<0.01).2.Comparing the total TCM evidence points of the two groups before and after treatment,the treatment group was better than the control group,and the difference was statistically significant(P<0.05).The effective rate of the treatment group was 76.7%,and the effective rate of the control group was46.7%.The response rate of the treatment group was superior to that of the control group.3.After treatment,the scores of depression,sighing frequently,discomfort in the pharynx,chest fullness,chest tightness,irritability,thirsty,abdominal distension,and insomnia and dreaminess were lower in the treatment group,with statistical significance(P<0.05),while no significant difference was found in the scores of excessive sweating and flustered compared with those before treatment.After treatment,the treatment group had better scores than the control group in terms of depression,discomfort in the pharynx,abdominal distension,and insomnia and dreaminess(P<0.01).4.The SERS scores of the two groups before and after treatment were better than those of the control group,and the difference was statistically significant(P<0.05).5.The comparison of thyroid function(TSH,FT3,FT4)before and after treatment was not statistically significant between the control group and the treatment group(P>0.05),there was no significant difference in thyroid function between the two groups before and after treatment.6.No adverse reactions occurred in each group during the treatment.Conclusion:The combination of Shuganyuying Decoction and low-dose flupentixol and melitracen tablets was effective in improving the SAS and SDS scores of postoperative DTC patients with anxiety and depression,which is identified by traditional Chinese medicine as liver-depression and qi-stagnation evidence;it also reduced the total TCM symptoms score of patients and was effective in improving the TCM symptoms related to anxiety and depression,such as depression,sighing frequently,discomfort in the pharynx,chest fullness,chest tightness,irritability,thirsty,abdominal distension,and insomnia and dreaminess in patients,but it is not effective in treating excessive sweating and flustered.The combination of Shuganyuying Decoction with small doses of flupentixol and melitracen tablets is significantly superior to simple Western medicine in reducing depression,discomfort in the pharynx,abdominal distension,and insomnia and dreaminess points.The antidepressant side effects produced by the combination of Shuganyuying Decoction with small doses of flupentixol and melitracen tablets are small.In terms of thyroid hormones,Shuganyuying Decoction has no significant effect on thyroid function and does not affect the TSH suppression treatment with postoperative levothyroxine sodium tablets.It is safe and reasonable in the treatment process,and has no significant effect on patients’ liver and kidney function without adverse reactions.The combination of Shuganyuying Decoction and low-dose flupentixol and melitracen can significantly improve the clinical symptoms and quality of life of postoperative DTC patients with anxiety and depression,which is identified by traditional Chinese medicine as liver-depression and qi-stagnation evidence. |