| 1 ObjectiveTo observe the changes of TCM clinical syndrome,thyroid hormone and bone metabolism index before and after the intervention of spleen-invigorating and kidney-tonifying method in patients with hypothyroidism,evaluate the clinical efficacy of spleen-invigorating and kidney-tonifying method in the treatment of hypothyroidism,and analyze its effect on bone metabolism index;and compared with normal healthy people,to understand the correlation between bone metabolism index and thyroid hormone,and to explore the mechanism of spleen-invigorating and kidney-tonifying method in preventing osteoporosis in patients with hypothyroidism.2 Methods(1)The subjects were outpatients and inpatients from the Department of Geriatrics-Endocrinology in the first affiliated Hospital of Anhui University of traditional Chinese Medicine from October 2019 to October 2020.A total of 60 patients with hypothyroidism with spleen and kidney yang deficiency syndrome were randomly divided into two groups.The control group was treated with L-T4 and the treatment group was treated with Lmurt T4+traditional Chinese medicine for 12 weeks.The indexes of FT3,FT4,TSH,bone metabolism and TCM syndrome scores were compared between the two groups before and after clinical intervention.(2)To compare the level of bone metabolism between normal health group and hypothyroidism group,and to explore the correlation between bone metabolism index and thyroid hormone.(3)Blood routine,biochemical and other safety indexes were detected,adverse reactions were monitored and drug safety was evaluated.3 Results(1)Thyroid function:after treatment,the levels of FT3 and FT4 increased and TSH decreased in the two groups,and the increase of FT3 and FT4 and the decrease of TSH were more prominent in the treatment group(P<0.05 or P<0.01).(2)Bone metabolic indexes:compared with normal control group,the levels of ALP,TRACP,OC in hypothyroidism group decreased and CTX-1 increased,ALP,TRACP,OC increased and CTX-1 decreased after treatment in hypothyroidism group,and the changes of bone metabolic indexes were more obvious after intervention with the method of invigorating spleen and tonifying kidney(P<0.05 or P<0.01).(3)The level of calcium and phosphorus:compared with normal subjects,the level of serum calcium in hypothyroidism group decreased(P<0.05),and that in hypothyroidism group increased(P<0.05),and that in treatment group decreased(P<0.05or P<0.01).In the control group,serum phosphorus decreased(P<0.05 or P<0.01),but there was no significant change in serum calcium(P>0.05).Compared between the two groups,the serum calcium increased significantly and the serum phosphorus decreased significantly in the treatment group(P<0.05 or P<0.01).(4)Correlation analysis:TSH was negatively correlated with ALP,TRACP,OC,and positively correlated with CTX-1;FT3 was positively correlated with ALP and TRACP,but not with CTX-1 and OC;FT4 was positively correlated with ALP,TRACP,OC,but not with CTX-1.(5)TCM syndrome scores:after treatment,the syndrome scores of the two groups were lower than those before treatment(P<0.05),and the decrease was more prominent in the treatment group(P<0.05).(6)Clinical efficacy:the effective rate of the treatment group was 96.67%,while that of the control group was 80%.Compared with the two groups,the curative effect of the treatment group was better(P<0.05).(7)Safety analysis:there was no abnormal safety index between the two groups before and after treatment,and there was no significant difference between the two groups(P>0.05).4 Conclusion(1)Patients with hypothyroidism have decreased bone metabolism,disorder of calcium and phosphorus metabolism,and relatively increased risk of osteoporosis.(2)The method of invigorating spleen and tonifying kidney combined with levothyroxine sodium tablets can significantly improve the level of thyroid hormone in patients with hypothyroidism,correct the disorder of calcium and phosphorus metabolism,improve bone metabolism indexes such as ALP,TRACP,OC,CTX-1,accelerate the process of bone formation and reduce bone resorption.(3)The method of invigorating the spleen and tonifying the kidney shows good clinical efficacy and safety in patients with hypothyroidism. |