| Objective: To explore the clinical efficacy of Jiawei Erxian decoction combined with levothyroxine sodium tablets(Youjiale)in the treatment of patients with immune-related hypothyroidism of spleen-kidney yang deficiency type malignant tumor,and to explore the safety and feasibility of the above-mentioned drugs.Methods: From January 2022 to November 2022,80 patients with malignant tumor immune-related hypothyroidism of spleen and kidney yang deficiency who met the inclusion and exclusion criteria were randomly divided into two groups.The treatment group was treated with levothyroxine sodium tablets(Youjiale)combined with Jiawei Erxiantang granules.The control group was treated with levothyroxine sodium tablets(Eutyroxine)alone.Observe a course of treatment,the course of treatment is 4 weeks.Before treatment,after 2 weeks of treatment,and after 4 weeks of treatment,monitor and record patients’ TCM syndrome scores,thyroid function scores,quality of life scores,clinical curative effect scores,safety evaluation,etc.Software analysis.Result:1.There was no significant difference in the general information(including gender,disease type,age,and immune drugs)between the two groups of patients,and the two groups of patients were comparable(P>0.05).2.TCM syndrome score: The TCM syndrome score of the two groups before treatment was compared between groups,and the difference was not statistically significant(P>0.05).After 2 weeks of treatment and after 4 weeks of treatment,the two groups were compared within the same group,and the differences were statistically significant(P<0.05).The effective rate of TCM syndrome curative effect in the treatment group was higher than that in the control group(94.74% vs 81.58%).The treatment group was better than the control group in improving TCM symptoms(P<0.05).3.Thyroid function score: There was no statistical significance in comparing the thyroid function laboratory indicators(serum TSH,FT3,FT4,TGAb,TPOAb)between the two groups before treatment(P>0.05).The thyroid function of the two groups was improved after 2 weeks and 4 weeks of treatment compared with before treatment(P<0.05),and the improvement effect in the treatment group was better than that in the control group(P<0.05).4.Quality of life score: There was no statistically significant difference in the KPS score between the two groups before treatment(P>0.05).The quality of life of the two groups of patients after treatment was improved compared with that before treatment(P<0.05);the degree of improvement in the treatment group was better than that in the control group(P<0.05).5.Clinical efficacy score: The clinical effective rate of the treatment group was higher than that of the control group(86.84% vs 76.32%),and the clinical efficacy of the treatment group was better than that of the control group in the treatment of malignancy immune-related hypothyroidism(P < 0.05).6.Safety evaluation: Before treatment,after 2 weeks of treatment,and after 4 weeks of treatment,blood routine,liver and kidney functions were compared within and between groups,and there was no statistically significant difference(P>0.05).The incidence of adverse reactions in the treatment group was lower than that in the control group(5.26% vs26.32%),and the safety of the treatment group was better than that in the control group(P<0.05).Conclusion: Modified Erxian Decoction combined with Levothyroxine Sodium Tablets(Youjiale)has clinical curative effect,safety and improvement of clinical symptoms,thyroid function and quality of life in patients with malignant tumor immune-related hypothyroidism of spleen and kidney yang deficiency.Both were superior to single-drug levothyroxine sodium tablets(Eutyroxine). |
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