The Intervention Of Jian-pi-bu-shen-huo-xue Decoction To Inhibitors-associated Osteoporosis In Postmenopausal Women Receiving AIs

Objective:To observe the effect of Jian-pi-bu-shen-huo-xue decoction on clinical symptoms,bone mineral density,related bone metabolic markers and estrogen levels of osteoporosis treated with AIs in breast cancer.Method:Forty patients who met the inclusion criteria were selected clinically and randomly divided into treatment group and control group,with 20 in each group.Control group is treated with basic calcium and vitamin D.On the basis of the control group,The treatment group is treated with Jian-pi-bu-shen-huo-xue decoction(Codonopsis,fried largehead,poria,licorice,psoralen,antler glue,achyranthes,mulberry twig,turmeric,purple salvia),and addition and subtraction with the disease.Both courses of treatment are 6 months.Clinical score of symptoms of TCM,BMD of lumbar spine and femoral neck,bone turnover makers(serum alkaline phosphatase(ALP),bone gla protein(BGP),25-hydroxyvitamin D3(25-OH-VD3),type I collagen carboxy-terminal peptide(CTX),type I procollagen amino-terminal peptide(PIMP),estradiol(E2)and liver and kidney function,TM six,ECG,breast ultrasound and other safety indicators were observed before treatment and after 6 months.Results:(1)Clinical symptoms of TCM:The 'X±S of the control group is 16.00 ±6.51 before treatment,and 18.95 ±4.36 after 6 months.The 'X±S of the treatment group is 16.55 ±6.43 before treatment,and 11.25 ±5.06 after 6 months.The total score of TCM symptom after 6 months of treatment is more serious than that before(P<0.05)in the control group,and the total score of TCM symptom after 6 months of treatment in the treatment group is significantly better than before(P<0.05).After treatment,the overall score of TCM symptoms in the treatment group is significantly improved compared with the control group(P<0.05).The scores of individual symptoms of TCM clinical symptoms before treatment are compared to after treatment in the treatment group and the control group respectively,and in the control group,the symptoms of lumbar and knee acid,fatigue,hot flashes and sweating,and tongue after treatment are all worse than before(P<0.05).In the treatment group,the symptoms of lumbar back pain,muscle thinness,fatigue,complexion,cold and cold limbs,hot flashes and sweating,insomnia,forgetfulness,dizziness,faintness,lazy speech,poor appetite,frequent night urination,local(tingling,constant pain,refusing to press)symptoms and pulse after treatment are all better than before(P<0.05).The scores of individual symptoms of TCM clinical symptoms after treatment in the treatment group are compared with the control group,and the symptoms of lumbar back pain,lumbar and knee acid,muscle thinness,fatigue,cold and cold limbs,hot flashes and sweating,insomnia,forgetfulness,dizziness,poor appetite,frequent night urination,local(tingling,constant pain,refusing to press)symptoms in the treatment group are all better than those in the control group(P<0.05).(2)Pain score:Before treatment,the 'X ± S of pain score of the control group is 4.05+ 2.28,and it is 5.10 ± 1.86 after 6 months of treatment(P<0.05),suggesting that the pain level of the control group after 6 months of treatment is worse than before treatment,and it is statistically significant;the 'X ± S of pain score before treatment of the treatment group is 4.05 ± 2.44,and it was 3.20 ± 1.99 after 6 months(P<0.05),suggesting the Jian-pi-bu-shen-huo-xue decoction-treated groups after treatment 6 months of treatment is more significantly improved before treatment and it is statistically significant.Comparing the pain scores of the two groups after treatment,there is a significant difference(P<0.05),suggesting that the pain degree of the treatment group after treatment is significantly improved compared with the control group.(3)Bone mineral density:There is no significant difference in the lumbar spine L1-4 bone mineral density T score between before and after treatment and the in the femoral neck bone mineral density T score respectively in the two groups(P>0.05).And after treatment,lumbar spine L1-4 BMD T score and the T score of the femoral neck BMD are not significantly different between the two groups(P>0.05).After 6 months of treatment,the rate of change in the total T score of the lumbar spine L1-4 BMD in the treatment group is 3.21 ± 11.70%('X±S),and it is-6.05 ± 13.35%in the control group.The rate of change in the T score of femoral neck BMD in the treatment group is 1.96±11.93%('X±S),and it is-5.57±11.75%in the control group.(4)Bone turnover makers:Comparing the results of ALP,BGP,25-OH-VD3,CTX,and PINP between the two groups respectively,the results of ALP,BGP,25-OH-VD3,CTX,PINP of the control group,and the treatment group,s ALP,BGP,25-OH-VD3 results are all no significant difference between before and after treatment(P>0.05).The results of CTX and PINP of the treatment group have decreased significantly after treatment(P<0.05).By 6 months after therapy,respectively,taking the two groups' ALP,BGP,25-OH-VD3,CTX,and PINP results for comparison,the conclusion showed that the P values are all>0.05 and there is no significant difference.(5)Efficacy:After 6 months treatment,in the control group,0 cases are cured,0 cases show effect,0 cases are effective and 20 cases are invalid;and in the treatment group,0 cases are cured,1 example show effect,11 cases are effective,and 8 cases are invalid.Then,using the rank sum test,Z=-4.068,P<0.05,it is statistically significant.(6)safety indicators:After 6 months of treatment,the treatment and the control groups' E2 levels are significantly decreased than before treatment respectively(P<0.05),and it is statistically significant.There is no significant difference in E2 levels between the two groups after treatment(P>0.05).In addition,during the study,there are no clinically significant cardiac,hepatic,and renal abnormalities,and no local recurrence of breast cancer,new development of the contralateral breast,distant metastasis,or abnormally elevated tumor index.Conclusion:The Jian-pi-bu-shen-huo-xue decoction can significantly improve the symptoms of spleen and kidney deficiency and blood stasis and pain degree in post-menopausal women with breast cancer who are taking AIs.And it can improve many symptoms,such us bone and joint pain,hot flashes and sweating,insomnia,forgetfulness,poor appetite,etc.Furthermore,it can reduce the level of PINP and CTX,improving the high bone metabolism state in postmenopausal women,and inhibiting bone resorption.For BMD of improvement,although no significant effect,it may delay BMD further aggravated caused by AIs in breast cancer patients.At the same time,the change of E's level without obvious significance by Jian-pi-bu-shen-huo-xue decoction and there is no effect on the therapeutic efficacy of breast cancer.