| Objective: To explore the effectiveness and safety of Xiaoyan Decoction for maintenance treatment of advanced negative driver gene non-small cell lung cancer by retrospective research.Methods: Retrospective analysis of 128 patients with advanced driver gene-negative NSCLC who were treated in our hospital and Tianjin Cancer Hospital after 4-6 cycles of first-line treatment from January 1,2014 to December 31,2018.Analyzed and compared the effectiveness and safety of Xiaoyan Decoction combined with chemotherapy maintenance treatment group(observation group,62 cases)and chemotherapy maintenance treatment group(control group,66 cases).The main observation index is Progression-free Survival(PFS),the secondary observation index is Overall Survival(OS),Objective Response Rate(ORR),Disease Control Rate(DCR),functional status(Karnofsky,KPS)score,quality of life score,lung cancer TCM symptom score,safety,further analysis of gender,age,smoking history,TNM staging,chemotherapy maintenance drugs,maintenance treatment cycle,pathological type,TCM syndrome The influence of factors such as type,metastasis and other factors on the prognosis of patients,to explore the possible benefit of the group with modified Xiaoyan Decoction combined with chemotherapy to maintain the treatment of advanced driver gene-negative NSCLC.The SPSS26.0 software was used for statistical analysis,and the difference was statistically significant with P<0.05.Results: This study included 128 patients with advanced driver gene-negative NSCLC,including 62 in the observation group and 66 in the control group.The two groups were in gender,age,smoking history,drinking history,TNM staging,pathological type,and primary focus.Baseline characteristics such as location,lymph node metastasis,number of distant metastases,evaluation of efficacy after first-line chemotherapy,maintenance of chemotherapy,and maintenance of KPS score before treatment were balanced,all of which were not statistically significant(P>0.05).Main Outcome Measures: Media Progression-free Survival(m PFS): Xiaoyan Decoction combined with chemotherapy maintenance treatment can prolong m PFS in patients with advanced driver gene-negative NSCLC compared with chemotherapy alone maintenance,respectively 6.3 vs.5.6 months,The difference was statistically significant(P<0.05).Secondary observation indicators:(1)OS: Modified Xiaoyan Decoction combined with chemotherapy maintenance treatment for patients with advanced driver gene-negative NSCLC had a prolonged median OS(Media Overall Survival,m OS)compared with chemotherapy alone maintenance,respectively 14.8 vs.13.5 months,But the difference was not statistically significant(P>0.05).(2)Evaluation of objective curative effect of tumor: ORR of observation group was11.3%,DCR was 77.4%;ORR of control group was 7.6%,DCR was 65.2%.The ORR and DCR of the observation group were higher than those of the control group,but the difference was not statistically significant(P>0.05).(3)KPS Score: The KPS score of the observation group before and after treatment was compared within the group.The median KPS score of 90 points after treatment was significantly higher than that of 80 points before treatment,and the difference was statistically significant(P<0.05);KPS score after treatment in the group,the median KPS score was 90 points vs.80 points,the observation group was significantly improved,with statistical significance(P<0.05);comparison between the two groups before and after treatment KPS score improved efficacy,the observation group improved significantly,The total effective rate was 72.6% vs.24.2%(P<0.001),the difference was statistically significant.(4)Quality of life evaluation: The role function,emotional function,and overall health of the observation group improved better than those of the control group,and the difference was statistically significant(P<0.05);the physical function,social function,and cognitive function of the observation group were better than the control group Improved,but not statistically significant(P>0.05).(5)Lung cancer TCM symptom score: To evaluate the improvement of individual lung cancer symptom scores between the two groups,the observation group was better than the chemotherapy maintenance group in improving the five symptoms of fatigue,loss of appetite,nausea and vomiting,cough,and expectoration.The difference was statistically significant(P<0.05),the observation group was generally better than the control group in the improvement of other symptoms,but it was not statistically significant(P>0.05);the overall improvement of the TCM symptom scores of lung cancer in the two groups was evaluated,and the observation group was significantly benefited from the improvement of the overall symptoms,The overall symptom relief rate was 67.7% vs.39.4%,the difference was statistically significant(P<0.05).(6)Safety evaluation: The two groups of blood,liver,and kidney toxicity were mainly graded as grade I and grade II.Compared with the control group,the incidence and grade of adverse reactions in the observation group are generally lower.Among them,the incidence of anemia is reduced,and there is a difference There was statistical significance(P<0.05),and the other aspects were not statistically significant(P>0.05).There were fewer third-degree adverse reactions,the observation group included 1 case of leukopenia,1 case of neutropenia,and 1 case of platelets Reduced,the control group included 3 cases of leukopenia,3 cases of neutropenia,2 cases of thrombocytopenia,and 2 cases of anemia.Both groups did not have grade IV blood,liver,and kidney toxicity.(7)Analysis of prognostic factors in subgroups: Kaplan-Meier univariate survival analysis of the observation group found that people with stage ⅢB,squamous cell carcinoma,lung-spleen-qi deficiency syndrome,and >4 cycles(Long-term treatment)maintenance treatment might be treated with Xiaoyan Decoction plus or minus combined chemotherapy Benefit from maintenance treatment;multivariate Cox regression analysis of the observation group found that TNM staging and maintenance treatment cycle were independent factors affecting the prognosis of PFS.Compared with stage ⅢB,stage Ⅳwas a risk factor affecting the prognosis of PFS,>4 cycles(Long-term treatment)maintenance treatment was a protective factor that affects the prognosis of PFS.Conclusion: Xiaoyan decoction combined with chemotherapy for maintenance treatment of advanced driver gene-negative NSCLC patients has the effect of prolonging PFS,alleviating clinical symptoms,improving quality of life and having good safety.The better group of patients who benefit is squamous cell carcinoma,lung-spleen qi deficiency syndrome,stage IIIB and long-term(>4 cycles)maintenance treatment. |
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