| Objective:A retrospective analysis of the clinical efficacy and safety of the Fuzheng Jiedu Heluo therapy combined with the standard Western medical regimen in the second-line treatment of patients with driver gene-negative advanced squamous lung cancer.Method:By collecting patients with advanced lung squamous cell carcinoma diagnosed by the Cancer Center of the first affiliated Hospital of Anhui Medical University from January 1,2020 to December 31,2022,the patients with advanced lung squamous cell carcinoma were treated with Fuzheng Jiedu Heluo therapy combined with western medicine standard second-line treatment regimen(combined group)compared with simple western medicine standard second-line treatment group(control group).To evaluate the clinical efficacy and safety of the two groups after 2 treatment cycles.Main outcome measures: PFS and OS.Secondary outcome indicators: solid tumor efficacy evaluation,tumor markers,KPS score,TCM syndrome score and adverse events.Result:A total of 82 cases were included in this study,including 42 cases in the combination group and 40 cases in the control group.There was no statistical difference in the baseline data between the two groups before treatment.Main outcome indicators1.mPFS: mPFS in the combination group was 4.4 months(95%CI:3.482-5.318),and mPFS in the control group was 4.0 months(95%CI:3.308-4.692),P = 0.033 < 0.05,and mPFS in the two groups was statistically different.2.mOS: mOS in the combination group was 11.1 months(95%CI:10.287-11.913),and mOS in the control group was 10.3 months(95%CI:8.734-11.866),P > 0.05,and mOS in the two groups was not statistically significant.Secondary outcome indicators1.Evaluation of solid tumor efficacy: 1 case of CR,11 cases of PR,23 cases of SD,7 cases of PD,ORR of 28.6%,DCR of 83.3% in the combined group;0 cases of CR,9cases of PR,22 cases of SD,9 cases of PD,ORR of 22.5%,DCR of 77.5% in the control group;no statistical difference in clinical efficacy was seen between the two groups(P>0.05).2.Tumor markers: there was no statistical difference in the changes of SCC and CYFRA21-1 levels between the combined group and the control group after treatment(P > 0.05),and there was also no statistical difference before and after intra-group comparison(P>0.05).3.KPS score: Among the 42 patients in the combined group,5 cases were markedly effective,15 cases were effective,19 cases were stable,and 3 cases were ineffective,with a total effective rate of 47.6%.Among the 40 patients in the control group,3 cases were markedly effective,9 cases were effective,23 cases were stable,and 5 cases were ineffective.The total effective rate was 30%,and there was no statistical difference between the groups(P=0.103>0.05).4.TCM syndrome score: in the improvement of TCM syndrome total score,in the combined group,6 cases were significantly improved,19 cases were partially improved,14 cases were stable,3 cases were aggravated,and the effective rate was 59.5%.Among the 40 cases in the control group,3 cases were significantly improved,12 cases were partially improved,19 cases were stable,6 cases were aggravated,and the effective rate was 37.5%.The results showed that the combined group was significantly better than the control group in improving the total score of TCM syndromes(Please 0.041 < 0.05).In terms of improving the curative effect of individual TCM syndrome scores,the combined group was superior to the control group in terms of fatigue,anorexia,expectoration,nausea and vomiting,and night restlessness,with statistical difference(P< 0.05).There was no significant difference in cough,hemoptysis,chest pain,shortness of breath and constipation between the two groups(P > 0.05).5.Occurrence of adverse reactions: Compared with the control group,the incidence of adverse events in the combination group was generally lower,and the degree of adverse reactions was milder,among which the differences in anorexia,nausea and vomiting,and fatigue were statistically significant(P<0.05);other adverse reactions In terms of reaction,the incidence rate of the combination group was lower than that of the control group,and the difference was not statistically significant(P>0.05).Conclusion:1.Fuzheng Jiedu Heluo therapy combined with standard second-line regimen in western medicine for patients with driver gene-negative advanced squamous lung cancer can improve patients’ progression-free survival and has a tendency to prolong patients overall survival.2.The application of Fuzheng Jiedu Heluo therapy significantly reduced the clinical symptoms of TCM syndromes such as tiredness,lack of food,expectoration,nausea and vomiting,and restlessness in patients with advanced lung squamous cell carcinoma,and improved the quality of life of the patients.3.The use of the Fuzheng Jiedu Heluo therapy effectively reduced the incidence and severity of adverse reactions such as loss of appetite,nausea and vomiting,and weakness during the treatment of patients with advanced squamous lung cancer. |
PDF Full Text Request