| Objective:To observe the clinical efficacy and safety of Yifei septic prescription in the treatment of Qi-yin deficiency,phlegm-stasis internal junction type EGFR wild typeⅢB-ⅣNSCLC patients.Methods:Sixty-eight cases were randomly divided into two groups:treatment group and control group.The patients with non-squamous cell carcinoma selected PP regimen(pemetrexed disodium 500 mg/m~2 for injection and cisplatin 75 mg/m~2 for injection).Both chemotherapy regimens were followed up for 2 cycles in 21-28 days.Both groups were treated before and after treatment(first cycle c hemotherapy).The patients with treatment group were able to continue to take advantage of lung sepsis before and after treatment.The patients with control group were able to continue to take the treatment of lung sepsis before and after treatment.The trea tment group patients were able to select pure traditional Chinese medicine for treatment and/or to continue chemotherapy.After the treatment of the two groups,PFS and MST were recorded in the follow-up manner.Results:Before treatment,the two groups were comparable in terms of age,sex,pathological classification,clinical stage,TCM syndrome,quality of life,weight and tumor markers.After treatment,the effective rate of the treatment group was 76.67 and that of the control group was 46.67.The advantage of the treatment group was significantly lower than that of the control group(p<0.05),especially in improving cough and phlegm,fatigue,self-sweating and night sweating.In improving KPS score,the effective rate of treatment group was 73.33,the eff ective rate of radiation group was 63.33,and the treatment of simple Yifei Baidu prescription could significantly improve the quality of life of patients(P<0.05).There were 30 cases in treatment group.Only 2 cases had nausea and vomiting,3 cases had diarrhea and the symptoms were mild.In the control group,there were 9 cases of bone marrow suppression,18 cases of nausea and vomiting,1 case of diarrhea,3 cases of constipation,5 cases of liver function injury,3 cases of renal function injury,1 case of peripheral neuropathy and 1 case of other(hair).A side effect of a drug.The incidence of side effects in the treatment group was significantly lower than that in the control group(P<0.05).The treatment group was inferior to the control group(ORR:0%vs 13.33,but DCR:53.33%vs 63.33).There was no significant difference between the two groups(P>0.05).Although the effective rate of the treatment group was higher than that of the control group(76.67%vs 56.67),there was no significant diffe rence(P>0.05).7.PFS:the median PFS:122 days in the treatment group and the median PFS:135 days in the control group were lower than those in the control group(P<0.05).Compared with the treatment group,the PFS of the control group was 13 days longer than that of the treatment group(P>0.05).8.MST:because the follow-up time was still short and the end point of MST was not reached,the follow-up should be continued.Conclusion:The treatment of Qi-Yin deficiency,phlegm stasis and internal knot of phlegm and blood stasis in patients with EGFR wild-typeⅢB-ⅣNSCLC has the advantages of improving the clinical syndrome of TCM and improving the quality of life,especially in improving cough and phlegm,fatigue,self-sweating and night sweating.The effect of thirst and drink symptom was obvious,and there was no obvious adverse drug reaction.In the aspect of tumor control,the curative effect of traditional Chinese medicine alone was not as good as that of combined chemotherapy group,but the two groups had the same curative effect in stabilizing tumor body DCRs.The curative effect of traditional Chinese medicine alone was not as good as that of combined chemotherapy group in controlling tumor marker Syfra21-1SCC,but in prolonging the survival time of patients,the curative effect of PFS in the two groups was the same as that in the combined chemotherapy group and the traditional Chinese medicine treatment group. |
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