The Risk Factors In Bone Metastasis Of Non-small Cell Lung Cancer And Interventional Research Of Xiaoyan Decoction

ObjectiveThis study aims to provide theoretical basis for clinical identification of high-risk patients by analyzing the risk factors of bone metastasis in non-small cell lung cancer.To observe the Clinical efficacy of "Xiaoyan Decoction" combined with zoledronic acid in the treatment of NCSLC with bone metastases which were the type of Qi-deficiency and Toxic-stasis,then we evaluate the "synergistic and attenuating effect of "Xiaoyan Decoction"in the treatment process and explore a better treatment options for patients with bone metastases from lung cancer.MethodsIn the first part,through literature search and clinical observation,the factors that may cause bone metastasis in non-small cell lung cancer were screened out.Then a questionnaire consistent with this study was formulated.Previous clinical data that met the criteria were collected through inclusion criteria,including basic population information,disease diagnosis information,disease treatment information and related biochemical indicators.Such as gender,age,BMI,tobacco and alcohol history,tumor family history,pathological type,clinical stage,genetic mutation;the treatment history of surgery,radiotherapy,chemotherapy,targeted,immunotherapy and Traditional Chinese Medicine(TCM);the level of tumor markers,lymphocytes,coagulation function,D-dimer,alkaline phospholipase(ALP),serum calcium,etc.single factor analysis was performed on all factors first,then multi-factor Logistic regression analysis was performed on statistically significant factors to identify risk factors for bone metastases in NSCLC.The second part:Collecting NSCLC patients with bone metastases in the type of Qi-deficiency and Toxic-stasis according to the inclusion and exclusion criteria.Randomly dividing them into control group and treatment group.Both groups received maintenance therapy with zoledronic acid,and the treatment group took"Xiaoyan Decoction"on this basis.Then,the degree of improvement and the occurrence of adverse reactions on the patients' bone metastasis,Osseous pain,TCM syndrome score,Karnofsky perform status score(KPS),T lymphocyte subsets,serum calcium,alkaline phosphatase and other indicators were observed and evaluated in both two groups.ResultsThe first part:a total of 180 questionnaires were issued in this study,and 152 were effectively recovered,including 65 patients with bone metastasis and 87 patients with non-bone metastasis.After a single factor analysis,the proportion of gender,age,BMI,smoking and drinking history,Family history of tumors,pathological types,EGFR/ALK mutations,treatment methods and the level of coagulation function(except PT,APTT),tumor markers,T lymphocyte subsets had no significant difference(P>0.05),but there were significant differences in T-stage,N-stage,KPS score,and the level of PT,APTT,PLT,ALP(P<0.05).After multi-factor Logistic regression analysis,the results showed that the T-stage,N-stage,KPS Scores,ALP levels are the risk factors of bone metastases in NSCLC,while the level of PT,APTT,PLT levels were not(P>0.05).Part II:According to the inclusion and exclusion criteria,60 eligible patients in NSCLC with bone metastases of the type of Qi-deficiency and Toxic-stasis were collected and divided into control group and treatment group randomly.Each group had 30 patients,and they were comparable before treating.After 4 cycles of intervention,the treatment group showed the advantages of relieving bone metastasis,Osseous pain,TCM symptoms,the level of ALP,serum calcium,T lymphocyte subsets and the KPS score(P<0.05);Adverse reactions such as fever,muscle aches,nausea and vomiting occurred in some patients and the levels of Scr and BUN mildly increased in both groups.Furthermore,the treatment group showed a decrease in platelet levels.The level of fever and the infulences of Scr and BUN levels were more acceptable than the control group(P<0.05).Conclusion1.Patients with T4 staging,N3 staging,KPS score<70,and high ALP levels are at greater risk of bone metastasis.2."Xiaoyan Decoction" can enhance the anti-bone metastasis effect of zoledronic acid by relieving the bone metastases,the osseous pain,the peripheral blood alkaline phosphatase and blood calcium levels.3."Xiaoyan Decoction" can significantly reduce the level of TCM symptoms in pain,waist and knee weakness,fatigue,upset and insomnia.The treatment can improve the quality of life.4."Xiaoyan Decoction" can up-regulated the proportion of CD3+,CD3+/CD4+,and CD3+/CD8+cells in the T lymphocyte subsets.5."Xiaoyan Decoction" can play a role in anti-platelet aggregation,and can reduce the Occurrence of drug-induced fever and decrease the effect of renal function by Zoledronic acid.