| Objective:(1)Through literature research,relevant outcome indicators for the treatment of metastatic NSCLC with simple chemotherapy under clinical large sample data were obtained as a comparative evaluation basis.(2)Through clinical real-world research,we preliminarily evaluate the clinical efficacy and safety of Gufei Xiaoji Decoction combined with chemotherapy in the treatment of metastatic NSCLC,as well as the advantageous population characteristics of Gufei Xiaoji Decoction,providing scientific basis for the treatment of metastatic NSCLC with traditional Chinese medicine.Methods:(1)Meta analysis of clinical literature: Literatures related to TCM treatment of advanced NSCLC were selected from CNKI,VIP and Wanfang databases during the past 10 years from January 2012 to December 2021.According to the inclusion and exclusion criteria,42 literatures were finally included,involving a total of 2,965 cases.Statistical analysis was performed using Rev Man5.3 software.Progression-free survival,objective remission rate,disease control rate,TCM syndrome improvement score,KPS score,weight change,common adverse reactions(including myelosuppression,nausea and vomiting,liver and kidney function injury,peripheral nerve injury)were used as observation indexes.The effectiveness and safety indexes of chemotherapy alone were obtained as the evaluation basis.(2)Clinical real world Research: The inpatients and outpatients of Hunan Hospital of Integrated Traditional Chinese and Western Medicine and the inpatients of Hunan Cancer Hospital from June 2020 to June 2022 were selected according to the exclusion criteria,and grouped according to SPSS random semicolon method.74 cases were finally included,including 38 cases in the Gufei Xiaoji Decoction combined chemotherapy group and 36 cases in the single chemotherapy group.The efficacy and safety were compared between groups,and the outcome indexes of Gufei Xiaoji Decoction combined with chemotherapy were further compared with those of chemotherapy alone in literature studies.According to "progression-free survival ≥8 months",Gufeixiaoji Decoction combined with chemotherapy group was divided into "advantaged population group" and "non-advantaged population group".SPSS25.0 statistical software was used to analyze the characteristics of advantaged population in the treatment of metastatic NSCLC with Gufeixiaoji Decoction.Results:(1)Literature research: The Overall Response Rate(ORR)of chemotherapy group alone was 29.1%,and the Disease Control Rate,DCR)was 69.6%,TCM syndrome improvement rate was 48.1%,physical condition improvement rate was 24.3%,weight control rate was 59.1%,leukopenia rate was 62.6%,thrombocytopenia rate was 61.7%,hemoglobin reduction rate was71.9%,nausea and vomiting rate was 59.3%,liver function injury rate was 30.4%,kidney function The rate of energy injury and peripheral nerve injury was 21.4% and 43.7%.ORR of38.7%,DCR of 82.4%,TCM syndrome improvement rate of 77.3%,physical condition improvement rate of 44.5%,weight control rate of 85.5%,leukopenia rate of 39.2%,thrombocytopenia rate of 30.4%,hemoglobiosis rate of 29.6%,nausea and vomiting rate of32.3% in the TCM combined chemotherapy group,liver function injury rate was 15.7%,kidney function injury rate was 14.1%,peripheral nerve injury rate was 30.2%.(2)Clinical real-world studies:(1)Outcome indicators: After 2 cycles of Gufei Xiaoji Decoction combined with chemotherapy,the objective remission rate was 44.7%,the disease control rate was 86.8%,the improvement rate of TCM syndrome was 76.3%,the improvement rate of physical state was60.5%,the control rate of body weight was 89.5%,the reduction rate of leukocytes,platelets and hemoglobin were 44.7%,34.2% and 23.7%,respectively.The incidence of nausea and vomiting was 31.6%,liver function injury 10.5%,kidney function injury 13.2% and peripheral nerve injury 18.4%.In the single chemotherapy group,the objective remission rate was 30.1%,the disease control rate was 63.9%,the improvement rate of TCM syndrome was 44.4%,the improvement rate of physical state was 27.8%,the control rate of body weight was 61.1%,the reduction rate of leukocyte,platelet and hemoglobin was 69.4%,61.1% and 50%,respectively.The incidence of nausea and vomiting was 58.3%,liver function injury was 30.5%,renal function injury was 19.4%,peripheral nerve injury was 41.7%.There were statistically significant differences in disease control rate,improvement rate of TCM syndrome,improvement rate of physical state,weight control rate,leukocyte,platelet,hemoglobin reduction rate,incidence of liver function injury,peripheral nerve injury and incidence of nausea and vomiting between the two groups(P<0.05).The ORR,DCR,improvement rate of TCM syndrome,improvement rate of physical state,and weight control rate of Gufexiaoji Decoction combined with chemotherapy were all higher than those of chemotherapy alone,while the incidence of bone marrow suppression,nausea and vomiting,liver function injury,kidney function injury and peripheral nerve injury were all lower than those of chemotherapy alone.(2)PFS: m PFS was(8.20 ± 2.10)months in the traditional Chinese medicine combined chemotherapy group,and(6.80±0.72)months in the chemotherapy group alone.The difference was statistically significant(P<0.05).Tumor stage,treatment modality,and pretreatment KPS score were independent prognostic factors affecting PFS(P<0.05).(3)Logistic regression analysis results: under the condition of other factors being the same,Gufei Xiaoji Decoction combined with chemotherapy had better effect on deficiency of lung and temper and phlegm-stasis syndrome of metastatic NSCLC patients who took medicine for more than 6months(P<0.05).Conclusion:(1)Gufei Xiaoji Decoction combined with chemotherapy can reduce the toxic side effects of chemotherapy and synergistic effect.(2)Independent factors affecting PFS in metastatic NSCLC patients include treatment style,and pre-treatment KPS score.(3)Patients with metastatic NSCLC with deficiency of lung and temper and phlegm stasis and poison syndrome who have taken traditional Chinese medicine for a long time are the dominant population for survival benefit of Gufei Xiaoji Decoction treatment. |
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