| Objectives:1.Explore the influencing factors of breast cancer aromatase inhibitor-related arthralgia,and further screen out the influencing factors of its pain degree,and analyze the distribution of TCM syndrome types of breast cancer aromatase inhibitor-related arthralgia after menopause.From the perspective of traditional Chinese medicine and Western medicine,we will comprehensively improve the understanding of aromatase inhibitor-related arthralgia,in order to provide a theoretical basis for clinical research and prevention of breast cancer aromatase inhibitor-related arthralgia.2.By observing the clinical efficacy of Bushan Yishen Decoction in intervention of breast cancer aromatase inhibitor-related arthralgia,explore effective Chinese medicine methods to improve aromatase inhibitor-related arthralgia,in order to reduce the adverse effects of aromatase inhibitor,Improve patient compliance,and further improve the long-term efficacy of aromatase inhibitors.Methods:1.Study 1: Using the research method of questionnaire survey,135 patients who were treated in the oncology department of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from February 1,2020 to December 1,2020 were included in accordance with the inclusion criteria and were taking aromatization For postmenopausal breast cancer patients with enzyme inhibitors,analyze the distribution of TCM syndromes of patients with aromatase inhibitor-related arthralgias,and apply chi-square test to perform univariate analysis to initially screen the effects of aromatase inhibitor-related arthralgias Factors,and then analyze the above influencing factors through binary Logistic regression,and get their independent influencing factors.For patients with aromatase inhibitor-related joint pain,they are classified according to their pain degree,and the influencing factors related to pain degree are analyzed by the method of multivariate ordered Logistic regression.2.Study 2: According to the inclusion and exclusion criteria,64 cases of eligible cases in the Oncology Department of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from January 1,2020 to September 1,2020 were collected and randomized according to 1:1 The distribution principle is divided into the treatment group and the control group with 32 cases each.According to the elimination criteria,the treatment group and the control group each have 30 study subjects.The control group was treated with calcium carbonate D3 tablets orally,and the treatment group was treated with Bushan Yishen Decoction on the basis of oral calcium carbonate D3 tablets.Observe and evaluate the two ways to evaluate the patient’s concise pain score,morning stiffness time,TCM syndrome score,knee joint pain and stiffness function score,hand joint dysfunction score,bone density,serum calcium,serum phosphorus,serum alkaline phosphatase,Improvement of overall health status and occurrence of adverse reactions.Results:1.Study 1:(1)64 of the 135 patients enrolled in the group had aromatase inhibitor-related arthralgia,the incidence was 47.4%,and the median onset time was 3.5months after taking the drug.(2)The most common pain site for aromatase inhibitor-related arthralgia was 48 cases of hand/wrist(75%),followed by 39 cases of knee joint(60.9%),23 cases of waist(35.9%),shoulder joint 19 cases(29.7%),15 cases(23.4%)of hip joint,8 cases(12.5%)of foot/ankle.(3)The pain grade distribution of aromatase inhibitor-related arthralgia is mainly mild pain(62.5%),moderate pain second(28.1%),and severe pain the least(9.4%).(4)Among the patients with AIA,the distribution of TCM syndromes is the syndrome of liver and kidney yin deficiency(40.6%).(5)The distribution of TCM syndromes in AIA patients with moderate and severe pain is the syndrome of liver and kidney yin deficiency.(6)In the univariate analysis,the age,body mass index,age of menopause,years of menopause,history of chemotherapy,history of chemotherapy with taxanes,TCM syndrome type,bone density,calcium/calcium absorption promoting agent consumption,exercise There are 11 influencing factors related to the occurrence of AIA,including conditions and sunshine duration.(7)In the multi-factor analysis,it is concluded that age,chemotherapy history,TCM syndrome,bone density,calcium or calcium absorption promoting agent intake,exercise status,and sunshine duration are the independent factors that affect the occurrence of AIA.(8)In the multi-factor analysis of the pain degree of aromatase inhibitor-related arthralgia,it is found that age,TCM syndrome type,and bone density are independent factors influencing the degree of AIA pain.2.Study 2:(1)The treatment of Bugan Yishen Recipe plus calcium carbonate D3 tablets can significantly reduce the pain scores of patients,and the effect is better than that of the group taking only calcium carbonate D3 tablets(P<0.05).(2)The treatment of Bugan Yishen Decoction plus calcium carbonate D3 tablets can significantly shorten the morning stiffness time of patients(P<0.01),and the treatment of calcium carbonate D3 tablets alone does not significantly shorten the morning stiffness time of patients(P>0.05).(3)The treatment of Bugan Yishen Decoction plus calcium carbonate D3 tablets can significantly improve the patients’ various symptoms of traditional Chinese medicine,and the curative effect is better than that of the group taking calcium carbonate D3 tablets alone(P<0.05).(4)Both treatment groups can reduce the total score of TCM syndromes of patients.The effect of Bushan Yishen Recipe plus calcium carbonate D3 tablets is better(P<0.01).The clinical efficacy of TCM syndromes in the treatment group is 70%.The clinical curative effect of TCM syndromes in the control group was 26.7%,and the curative effect of the treatment group was significantly higher than that of the control group(P<0.01).(5)After treatment,the two groups can alleviate the dysfunction of knee and hand joints.The effect of Bushan Yishen Decoction plus calcium carbonate D3 tablets group is better than that of the control group(P<0.05).(6)Both groups can increase the bone mineral density of patients after treatment,and the treatment of Bushan Yishen Recipe plus calcium carbonate D3 tablets can increase the bone mineral density to a higher degree(P<0.05).(7)Both treatments of the two groups can increase the serum calcium of the patients,but the difference is not significant(P>0.05);the treatment of Bugan Yishen Recipe plus calcium carbonate D3 tablets can reduce the serum alkaline phosphatase level of the patients(P<0.05));The serum phosphorus levels of the two groups of patients did not change significantly before and after treatment(P>0.05).(8)The treatment of Bugan Yishen Recipe plus calcium carbonate D3 tablets can significantly improve the overall health status of the patients in 8 dimensions,and the curative effect is better than that of the calcium carbonate D3 tablets group(P<0.05).(9)There were no abnormalities in safety indicators such as estradiol and adverse events and adverse reactions such as fractures in the two treatment groups.Conclusions:1.Study 1:(1)The study shows that the distribution of TCM syndromes in patients with AIA is mainly the syndrome of liver and kidney yin deficiency,while the distribution of TCM syndromes in patients with moderate and severe pain is mainly the syndrome of liver and kidney yin deficiency.(2)Age <55 years old,history of chemotherapy,TCM syndrome is liver and kidney yin deficiency or spleen and stomach weakness,bone density is osteoporosis or bone mass reduction is an independent risk factor for AIA;calcium supplementation or calcium promotion Absorbents,regular exercise,daily sunshine time ≥ 30 minutes are independent protective factors for AIA.(3)Among patients with AIA,those who are younger than 55 years old,the TCM syndrome is liver and kidney yin deficiency,and the bone density is osteoporosis,the pain degree is higher.2.Study 2:(1)The effect of Bugan Yishen Decoction in treating AIA is definite,which can significantly reduce the pain score and functional dysfunction of the patient’s joints,shorten the time of morning stiffness,improve the clinical TCM syndrome of the patient,and comprehensively improve the health of the patient.(2)Bushan Yishen Recipe can increase the bone density of patients and reduce the serum alkaline phosphatase level.(3)There were no abnormalities in estradiol and other safety indicators,and no adverse events such as fractures and other adverse reactions during the treatment of Bugan Yishen Decoction. |
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