| Objective: To observe the curative effect of Sanjie Tongluo Granule combined with zoledronic acid in the treatment of patients with bone metastasis lesions and influence on the improvement of patients' pain scores,TCM syndromes and quality of life,as well as the effect on tumor markers,immune function and alkaline phosphatase.The study is to investigate the clinical effect of eliminating stagnation and activating collaterals method on the treatment of bone metastasis.Methods: 66 patients diagnosed with bone metastasis were enrolled in a completely random study,and were divided into control group and treatment group in a 1:1 ratio.The control group was treated with zoledronic acid as the basic treatment for bone metastasis,and the treatment group was treated with sanjie tongluo Granule on the basis of conventional treatment,with one cycle for 28 days and six cycles of continuous observation and treatment.After the end of the study,statistical methods were used to observe the changes of two groups of bone metastases and bone metastases progression-free time,pain relief rate,duration of pain relief and dosage of analgesics,as well as serum calcium,alkaline phosphatase,tumor markers(CEA,CA153,CA125 and CA199),immune index(CD3+,CD4+,CD8+,NK)changes,and TCM syndrome,carr's score and the improvement of life quality.The research is to evaluate the clinical effect and the safety of the treatment methods.Results:(1)Efficacy of bone metastasis: After treatment the objective response rate and disease control rate of the treatment group were higher than those in the control group.After 6 months of treatment the difference of objective response rate between the two groups was statistically significant(P < 0.05).The progression-free time of bone metastasis in the treatment group was higher than that in the control group,and the difference was statistically significant(P < 0.05).(2)Comparison of pain conditions: after 6 months of treatment,the effective rate and duration of pain relief in the treatment group were higher than the control group,and the dose of oxycodone at24 h was lower than that in the control group,with statistically significant differences(P < 0.05).(3)Kaline phosphatase(ALP)changes: 6 months after treatment,the serum ALP level of the treatment group was lower than that of the control group,and the difference was statistically significant(P < 0.05).(4)Changes in tumor markers:serum CEA and CA153 levels in the treatment group were lower than those in the control group at 6 months after treatment,with statistically significant differences(P <0.05).(5)Changes in immune indexes: after 6 months of treatment,CD3+ and CD4+levels in the treatment group were higher than those in the control group,with statistically significant differences(P < 0.05).(6)Improvement of TCM syndromes and clinical symptoms: after 4 months of treatment,the effective rate of TCM syndromes in the treatment group was higher than the control group,with statistically significant differences between the two groups(P<0.05).After 2 months of treatment,the improvement rate of symptoms of waist and knee tenderness in the treatment group was higher than the control group,with statistically significant differences between the two groups(P < 0.05).After 6 months of treatment,the improvement rates of pain symptoms,waist and knee pain and fatigue symptoms in the treatment group were all higher than those in the control group,with statistically significant differences(P<0.05).(7)Changes in functional status score(KPS): the effective rate at 4 months,6 months and 6 months after treatment were higher than the control group,and the differences between the two groups were statistically significant(P <0.05).(8)In the EORTC QLQ-BM22 scale after treatment,the scores of pain site module and functional disorder module in the treatment group were lower than those in the control group at the 4th and 6th months after treatment,and the differences were statistically significant(P < 0.05).Conclusion:(1)Sanjie Tongluo Granule can inhibit bone metastasis,improve objective remission rate and disease control rate.(2)Sanjie Tongluo Granule can alleviate the pain degree of bone metastasis,prolong the duration of analgesia and reduce the dosage of analgesics.(3)Sanjie Tongluo Granule can reduce the levels of serum CEA,CA153 and alkaline phosphatase,and inhibit the metabolism of bone metastases.(4)Sanjie Tongluo Granule can increase the quantity of CD3+ and CD4+cells to improve the patients' immune function.(5)Sanjie Tongluo Granule can improve the clinical symptoms of patients with bone metastasis and improve their quality of life. |
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