| Objective:1.Through clinical research,observe the clinical curative effect of Qilian mixture plus or minus combined chemotherapy in patients with lung and spleen Qi deficiency in advanced non-small cell lung cancer(No-Small Cell Lung Cancer,NSCLC),and the objective curative effect,quality of life and Compare adverse reactions with patients treated with chemotherapy alone to explore the effects of Qilian mixture addition and subtraction;2.By searching the TCM system pharmacology database and analysis platform(TCMSP),the effective active ingredients related to NSCLC in the monarch medicine Astragalus and Scutellaria barbata of Qilian mixture were screened,and different effective ingredients were selected in combination with the literature.Observe the inhibitory effects of different component ratios on the proliferation of A549 cells,screen the optimal ratio,provide a molecular level scientific evidence for Qilian mixture in the treatment of NSCLC,and provide new ideas and guidance for the standardized promotion and application of Qilian mixture in the later period.Methods:1.From October 2018 to October 2020,according to the inclusion criteria,preliminary screening will be carried out among outpatients and inpatients in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine,the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine and Shandong Cancer Hospital,and select those who meet the criteria After receiving their consent,they conducted TCM dialectics and screened out 76 patients with advanced NSCLC whose TCM syndromes conformed to the syndrome of deficiency of lung and spleen qi.They were randomly divided into two groups.The chemotherapy alone group selected the appropriate chemotherapy regimen according to different pathological types(AP,TP,GP chemotherapy regimens)for treatment,every 21 days as a treatment cycle,a total of 4 cycles of observation.The combined medication group was given Qilian Mixture plus or minus on the basis of AP,TP,GP chemotherapy regimens and combined medication at the same time.During the treatment period,the two groups of patients did not take other treatment regimens.To observe and compare the efficacy of solid tumors before and after treatment,tumor markers,and other quality of life indicators such as physical status,TCM symptom score,and quality of life indicators such as adverse reactions;2.The subjects of the in vitro cell experiment were selected from the human lung adenocarcinoma A549 cell line,and the active ingredients related to NSCLC in Astragalus and Scutellaria barbata were screened by TCMSP search,combined with the ingredients that have been proven to have anti-tumor effects in literature studies and previous experiments.The effective active ingredients of Astragalus membranaceus were selected from isorhamnetin and astragaloside IV,and the effective active ingredients of Scutellaria barbata were wogonin and quercetin,and the active ingredients were formulated according to the ratio of Qilian medicine in the original prescription of Qilian mixture.For the drug pair,the IC50 value of each group was measured by the CCK-8 method,and then the plate clone formation experiment and q-PCR experiment were performed to observe the effect of different drug pair ratios on the proliferation ability of A549 cells.Results:1.After 4 cycles of treatment,a total of 69 people finally completed the study program.In terms of solid tumor curative effect,most in stable condition,two groups of patients that some relief,a handful of progress,no complete remission cases,and there is no statistical difference between two groups(P > 0.05),but the combination group of patients with tumor markers CEA,CYFRA21-1,CA-125 level is pure chemotherapy group were reduced,the overall analysis shows that the stilbene lotus mixture of non-small cell lung cancer has curative effect,but in a short period of time can’t change the volume of tumors;Look from the patients quality of life,after the two groups after treatment ECOG physical status score and lung temper deficiency syndrome score was reduced and the and the amplitude of the combination group was greater,suggests that the stilbene lotus mixture can effectively improve the NSCLC patients’ physical condition,in improving the less gas lazy words,cough and expectoration,stay loose stools and chest tightness often syndrome of aspects such as the new treatment effect is particularly prominent;From the quality of life after treatment in both groups were part of patients with different degree of adverse reactions occur,such as bone marrow suppression,liver function,renal function,frequency of two groups of patients(P > 0.05),but(nausea,vomiting,gastrointestinal tract reaction frequency combination group of patients significantly lower than the pure chemotherapy group(P < 0.05),indicating that the stilbene lotus mixture can effectively reduce the gastrointestinal side effects of chemotherapy,improve the patients quality of life;2.In vitro cell experiment,a total of 4 groups of distribution ratios were established.CCK-8 experiment confirmed that all the 4 groups of drugs could inhibit the proliferation of A549 cells,and the inhibition ability was positively correlated with drug concentration.Tablet clone formation assay showed that the four drugs had different inhibitory effects on the proliferation of A549 cells,and the combination of astragaloside IV and baicalein had the strongest inhibitory effect.Q-PCR results showed that the four drugs could exert anti-tumor effects by affecting the expression levels of NSCLC-related factors TNF-α,TGF-β and IL-6,and inhibit the proliferation of A549 cells.Conclusion:1.Qilian mixture combined with chemotherapy can effectively improve some indications of advanced lung and spleen qi deficiency type NSCLC cancer patients,improve their quality of life,and reduce adverse reactions caused by chemotherapy.It is significantly better than chemotherapy alone in reducing the level of tumor markers,improving the physical state of patients and some symptoms of traditional Chinese medicine;2.The main drug pair of Qilian Mixure--the mixture of various components of Qilian Mixure can inhibit the proliferation of human A549 cells,in which the ratio of astragaloside IV to baicalin is the optimal ratio of selected components. |
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