| Objective:To observe the clinical efficacy of Shugan-Yishen-Tongluo Recipe in the treatment of bone loss in hormone receptor positive breast cancer patients caused by aromatase inhibitors under the guidance of the theory of liver and kidney homology,so as to provide clinical basis and experience for the treatment of aromatase inhibitor-associated bone loss by traditional Chinese medicine.Methods:1.According to the inclusion criteria,60 breast cancer patients who visited the breast surgery clinic and ward of Hebei Cangzhou Integrated Traditional and Western Medicine Hospital and Wang Zhenqiang’s clinic of the traditional Chinese Medicine Hall from January 2021 to June 2022 were included,and were randomly divided into a treatment group and a control group,with 30 patients in each group.Among them,one patient in the control group added other drugs on his own,and one patient in the treatment group lost contact.Finally,58 patients in this study completed all the treatment.2.The control group was treated with calcium carbonate D3 chewable tablets(specification: each tablet containing calcium element 500mg+Vit D3125iu),1 tablet each time,twice a day.The treatment group was added with Shugan-Yishen-Tongluo Prescription(Prepared Rehmannia Root,Chinese yam,Cornus officinalis,Goji Berry,Staghorn gum,radix bupleuri,Angelica sinensis,Paeonia lactiflora,Achyranthes bidentata,Eucommia ulmoides,teasel,Viscum coloratum,Liquidambaris Fructus),and modification according to symptoms.Observe the changes of bone density of lumbar spine(L1～L4)and hip joint,symptoms and total symptom scores of traditional Chinese medicine,serum alkaline phosphatase,blood calcium,blood phosphorus,Karl Fischer score,estradiol level and safety indicators in the treatment group and the control group before and after treatment for 3months.Use SPSS26.0 software for statistical analysis to evaluate the clinical efficacy of Shugan-Yishen-Tongluo prescription in treating bone loss related to aromatase inhibitor in breast cancer.Results:1.TCM symptom score: After treatment,the total TCM symptom score of the two groups of patients improved compared with that before treatment(P<0.05),and the treatment group was more effective(P<0.05).Compared with the patients in the two groups,the improvement of symptoms in the treatment group was better than that in the control group in terms of back pain,waist and knee tenderness,lower limb pain,limb weakness,dizziness,hot flashes,sweating,insomnia,forgetfulness,palpitation(P<0.05);There was no significant difference in the score of emotional depression symptoms between the two groups after treatment(P>0.05).2.Bone mineral density: Bone mineral density: After treatment,the lumbar bone mineral density of patients in both groups improved compared with that before treatment(P<0.05),and the curative effect of the treatment group was better than that of the control group(P<0.05).The bone mineral density of the hip joint in the treatment group also improved significantly compared with that before treatment(P<0.05),while the control group did not significantly improve(P>0.05).3.Serum alkaline phosphatase,blood calcium and blood phosphorus:The serum alkaline phosphatase of patients in the treatment group decreased compared with that before treatment(P<0.05),while the control group did not improve significantly(P>0.05);The comparison between the two groups was P<0.05;It shows that the treatment group is more effective in improving serum alkaline phosphatase.The blood calcium level of patients in the two groups increased after treatment(P<0.05),but there was no significant difference between the two groups(P>0.05);There was no significant change in blood phosphorus level before and after treatment in both groups(P>0.05).4.KPS score: After treatment,the KPS score of patients in the treatment group was improved compared with that before treatment(P<0.05),and the difference was statistically significant compared with that in the control group(P<0.05).The therapeutic effect of the treatment group was better than that of the control group.5.Estradiol level: The level of estradiol in the two groups after treatment decreased compared with that before treatment(P<0.05),and there was no statistical difference between the two groups after treatment(P>0.05).6.Adverse reactions: no adverse reactions occurred in both groups of patients during the whole treatment process,and the test results of safety indicators were normal.Conclusions:1.Shugan-Yishen-Tongluo prescription has a significant effect in improving the clinical symptoms of AIBL patients such as back pain,waist and knee tenderness,hot flashes and sweating,insomnia,etc.It can reduce bone loss,increase bone density,and improve the quality of life of patients.2.Shugan-Yishen-Tongluo prescription has no significant effect on the estrogen level of patients,and will not affect the benefits of endocrine therapy.3.No adverse reactions were found in the treatment of AIBL with Shugan-Yishen-Tongluo prescription,and the safety was good. |
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