| Objective The clinical efficacy of Shenqi Anticancer Decoction combined with gefitinib in treating stage Ⅳ non-small cell lung cancer with both qi and Yin deficiency was observed by comparing PFS,efficacy evaluation,clinical symptoms of traditional Chinese medicine,physical condition,tumor indexes and safety indexes.Methods According to the diagnosis and exclusion criteria,70 patients who were outpatients and inpatients of Jiaxing Traditional Chinese Medicine Hospital and Jiaxing First Hospital from November 2020 to May 2022 were selected as the study subjects,and the enrolled subjects were divided into 35 cases in the test group and 35 cases in the control group by stratified regional group randomization method.The test group was treated with Ginseng-Qi Anti-Cancer Formula combined with Gefitinib,while the control group was treated with Gefitinib alone.The patients were observed for PFS,efficacy evaluation,TCM clinical symptoms,physical status,changes in tumour markers and adverse reactions,and data were collected and collated after evaluation,and the results were analysed using SPSS 20.0.Results Six patients in this study were discharged due to noncompliance with treatment ormissed visits,so a total of 64 patients were eventually included in the statistical analysis,32 in the test group and 32 in the control group.1.The mPFS of patients in the test group was 12.26 months and that of patients in the control group was 10.71 months.The test group was better than the control group,and there was a statistical difference between the two groups(LogRank P=0.036<0.05).2.The objective effective rate of the test group was 62.50%and the disease control rate was 93.75%,while the objective effective rate of the control group was 56.25%and the disease control rate was 87.50%.After treatment,although the objective effective rate and disease control rate of the test group were higher than those of the control group,the differences in the efficacy evaluation of the two groups were not statistically significant(P>0.05).3.The improvement rate of KPS in the test group was 59.4%,and the improvement rate of KPS in the control group was 34.4%.The improvement rate of KPS score in the test group was significantly higher than that in the control group,and the difference between the two groups was statistically significant(P<0.05).4.The total effective rate of improvement of TCM symptoms in the test group was 87.50%,and the total effective rate of improvement of TCM symptoms in the control group was 65.63%,the total effective rate of improvement of TCM symptoms in the test group was significantly higher than that in the control group,and the difference between the two groups was statistically significant(P<0.05).5.The serum CEA value in the test group was(34.87±13.58)ng/ml,and the serum CEA value in the control group was(35.14±11.68)ng/ml,and the serum CEA level in both groups decreased after treatment compared with that before treatment,and the differences within both groups were statistically significant(P<0.05).The difference between the two groups was not statistically significant(P>0.05)when comparing the serum CEA level of the test group with that of the control group after treatment.6.7 cases(21.9%)of rash and 5 cases(15.6%)of diarrhea occurred in the test group,compared with 16 cases(50.0%)of rash and 15 cases(46.9%)of diarrhea in the control group,the incidence of rash and diarrhea in the test group was lower than that in the control group,and the differences were statistically significant;10 cases(31.3%)of liver function abnormalities occurred in the test group,compared with 11 cases(34.4%)in the control group,and the differences were not statistically significant.The difference between the two groups was not statistically significant(P>0.05).Conclusion The combination of Ginseng Anti-Cancer Formula and Gefitinib in the treatment of stage Ⅳ non-small cell lung cancer patients with Qi and Yin deficiency was able to prolong PFS,improve TCM symptoms and physical status,reduce the occurrence of rash and diarrhea adverse reactions,and have a good safety profile. |
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