A Cohort Study Of Xiaoaiping Injection Combined With First-line Chemotherapy In The Treatment Of Advanced Non-small Cell Lung Cancer

Background:lung cancer is one of the most malignant tumors with high incidence rate and mortality rate in China.It is highly malignant and hidden.It has great influence on the health of residents in China.Most lung cancer patients are in the advanced stage at the time of discovery,and lose the opportunity of surgical resection.Their 5-year survival rate is less than 10%.In recent years,with the popularization of the concept of early detection and early treatment,the survival rate has increased.Non-small cell lung cancer is the most common pathological type of lung cancer,accounting for 75%-85%of all lung cancer patients.Targeted therapy and chemotherapy have become the main treatment for advanced non-small cell lung cancer patients with tumor,and even many targeted drugs have far exceeded the effect of chemotherapy.However,for advanced NSCLC patients with no target gene mutation and therefore not suitable for targeted therapy,the status of standard first-line dual drug chemotherapy with platinum is still unshakable.With the continuous improvement of the evaluation system of modern medicine,the evaluation of the therapeutic effect of malignant non-small cell lung cancer is not limited to the control of tumor size and the extension of PFS and OS.Clinicians,patients and even patients' families are more and more concerned about how to improve the quality of life of patients with advanced tumor,the degree of chemotherapy pain and the reduction of complications without reducing the therapeutic effect.Previous clinical studies on the treatment of advanced non-small cell lung cancer with traditional Chinese medicine injection have shown that the combination of Xiao-ai-ping injection and first-line platinum containing dual drug chemotherapy has a considerable effect in stabilizing the tumor,improving the quality of life,and alleviating clinical symptoms,which is representative of many traditional Chinese medicine injection with the treatment of lung cancer.Objective:To study the therapeutic effect of Xiao-ai-ping injection combined with first-line dual drug chemotherapy for advanced non-small cell lung cancer.Methods:126 cases of advanced NSCLC with tumor were included in this study through multi center and cohort study.According to whether the patients received the treatment,they were divided into the exposed group(first-line chemotherapy+injection therapy)and the non exposed group(first-line chemotherapy)to receive the corresponding treatment.The chemotherapy plan shall be implemented according to the standard combination plan of platinum containing two drugs recommended by NCCN guidelines;the combination plan of Xiao-ai-ping injection and chemotherapy queue shall be implemented according to the standard first-line chemotherapy plan and the standard dose(60-100ml QD)of Xiao-ai-ping injection.The treatment period of this study is from enrollment to disease progression.The main outcome measures were objective effective rate(RR),disease control rate(DCR)and progression free survival(PFS)after two cycles of treatment,and the secondary outcome measures were the effect of the treatment on the integral changes of clinical symptoms and quality of life of patients.Spss22.0 software was used for data statistical analysis.Results:from November 1,2017 to October 31,2019,126 patients with advanced non-small cell lung cancer(phase ?-?)were enrolled in the study,64 patients were enrolled in the study,and 62 patients were enrolled in the study,There was no significant difference between the two groups in gender,age distribution,pathological type,pathological grade,metastasis site,clinical stage,KPS score,ec0g score,TCM symptom score,quality of life score and scores in various fields(P>0.05).The two groups were comparable in the inclusion baseline.The objective effective rate(RR)and disease control rate(DCR)were 42.2%and 71.9%in the chemotherapy group,40.3%and 67.7%in the chemotherapy group.P=0.832,0.615 were>0.05,the difference was not statistically significant.The mean PFS of the two groups were 4.03 ± 0.35 months and 3.43±0.28 months,respectively,P=0.11>0.05.For patients with age>60-<70,the mean PFS of the patients treated with Xiao-ai-ping injection combined with chemotherapy was prolonged(4.58 ± 0.54 months vs 2.76 ± 0.50 months,P<0.05).For the male patients,the mean PFS of the patients treated with Xiao-ai-ping injection combined with chemotherapy was prolonged(4.17± 0.42 months vs 3.14±0.33 months,P<0.05).Cox multivariate regression showed that age stratification factors and exposure factors contributed the most to Cox model.From the survival function,it can be seen that the combination of Xiao-ai-ping injection and chemotherapy has a protective effect on disease-free survival.From the risk function,it can be seen that the combination of Xiao-ai-ping injection and chemotherapy can reduce the risk of disease-free survival.Compared with the chemical treatment group,the total score of clinical symptoms of traditional Chinese medicine improved significantly(1.58± 2.14 vs 0.98± 1.69,P>0.05).Compared with the chemotherapy group,the quality of life of the patients was improved more significantly by the combination of Xiao-ai-ping injection and chemotherapy group.The improvement of body function was 0.92± 1.33 vs 0.47±0.82(P<0.05),and the overall health was 0.87±1.27 vs 0.39±1.41(P<0.05).Conclusion:there is no significant difference in the objective remission rate and disease control rate of patients with advanced non-small cell lung cancer treated with Xiao-ai-ping injection and chemotherapy alone after two cycles.In comparison with the PFS,the mean PFS of the chemotherapy group was longer than that of the chemotherapy group(4.03±0.35 months vs 3.43±0.28 months,P>0.05).Xiao-ai-ping injection combined with chemotherapy can better alleviate the clinical symptoms of traditional Chinese medicine,improve the quality of life of patients,especially significantly improve the physical function and general health of patients,significantly improve the symptoms of fatigue,in addition to the cognitive function of patients,pain,constipation and other clinical symptoms have improved to a certain extent.Patients aged 60-70 years and male patients may benefit more from the treatment of Xiao-ai-ping injection than other patients.Cox multiple factor regression analysis indicated that the combination of chemotherapy and Xiao-ai-ping injection could protect the disease-free survival period and reduce the risk of disease progression.