| Objective:To observe the clinical efficacy and safety of Kanglaite injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer(deficiency of both Qi and Yin).Methods:Thirty-two patients with advanced non-small cell lung cancer who met the inclusion criteria and were admitted to the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine and Hunan Cancer Hospital from December 2018 to October 2020 were selected and randomly divided into the treatment group and the control group,including 16 cases in the treatment group,2 cases of abscission,14 cases of actual effective cases and16 cases in the control group.The control group was treated with standard chemotherapy,while the treatment group was combined with Kanglaite injection(d1-14)on the basis of standard chemotherapy.Both groups were treated with 21 days as a treatment cycle,and a total of 4 cycles were observed.The changes of tumor body,Karlscher score,TCM clinical symptom score,lung cancer symptom score(LCSS),changes of tumor markers and toxic and side effects after chemotherapy were assessed.Results:(1)Efficacy evaluation of solid tumor: Solid tumor efficacy: ORR and DCR of the two groups were compared.After 2 cycles of treatment,ORR and DCR of the control group were 31.25% and 62.5%,and ORR and DCR of the treatment group were 35.71% and 85.71%,respectively.After 4 cycles of treatment,the ORR and DCR were 25% and 68.75% in the control group and42.86% and 85.71% in the treatment group.The results showed that there was no significant difference between the treatment group and the control group(P > 0.05).(2)KPS score: Before and after treatment,3 cases were improved,8 cases were stable,and 5 cases were decreased in the control group.The improvement rate of the control group was 18.75%.In the treatment group,6cases were improved,6 cases were stable,2 cases were decreased,and the improvement rate of the treatment group was 42.85%.The results showed that the treatment group improved the Karl-score better than the control group,the difference was statistically significant(P < 0.05).(3)TCM syndrome score:(1)Total scores of TCM syndrome: intra-group comparison showed that after 2 cycles of treatment,both groups were improved compared with before treatment,but the difference was not statistically significant(P > 0.05).After 4 cycles of treatment,both groups were improved compared with before treatment,and the difference was statistically significant(P < 0.05).Compared with the control group,there was no significant improvement in the treatment group after 2 cycles of treatment(P > 0.05),and there was significant improvement in the treatment group after 4 cycles of treatment(P < 0.05).(2)Effectiveness of TCM syndromes: After 4 cycles of treatment,the improvement rate of total TCM syndromes in the two groups was compared.The control group was 50%,and the treatment group was 92.85%,with statistical significance(P<0.05).(3)TCM main symptom score: the treatment group was significantly better than the control group in the improvement of cough,phlegm and blood,chest tightness,shortness of breath,chest pain and other major symptoms,the difference was statistically significant(P <0.05).(4)LCSS score comparison: There was no statistically significant difference in LCSS score between the two groups before and after 2 cycles of treatmentt(P > 0.05).After 4 cycles of treatment,LCSS score in the control group was higher than that before treatment,while that in the treatment group was lower than that before treatment,with statistically significant difference(P < 0.05).There was no significant difference between the two groups in the second cycle(P > 0.05).After the fourth cycle,the treatment group was significantly lower than the control group,with a statistically significant difference(P <0.05).(5)Tumor marker changes: The expression levels of CEA and CYFRA21-1were compared within the treatment group.The expression levels of the two tumor markers were similar in the control group after 2 and 4 cycles of treatment compared with before treatment,with no statistical significance(P > 0.05).The expression level of CYFRA21-1 in the treatment group after cycle 2 and cycle 4 was lower than that before treatment,and the difference was statistically significant(P < 0.05).The expression level of CEA was not significantly changed,and there was no statistical difference(P > 0.05).There was no significant difference in CEA expression level between the two groups after 2 cycles of treatment and 4 cycles of treatment(P > 0.05).There was no significant difference in CYFRA21-1 expression level between the two groups after 2 cycles of treatment(P > 0.05).CYFRA21-1 expression level in the treatment group was lower than that in the control group after 4 cycles of treatment.The difference was statistically significant(P < 0.05).(6)Safety comparison: The severity of adverse reactions such as myelosuppression,gastrointestinal reactions,liver function damage and renal function damage after chemotherapy was compared between the two groups.The overall incidence of adverse reactions and the incidence of grade 3 or above in the treatment group were lower than those in the control group.After4 cycles of treatment,myelosuppression and gastrointestinal reactions in the treatment group were slightly lower than those in the control group,and the differences were statistically significant(P < 0.05).There was no significant difference in liver and kidney function(P > 0.05).Conclusion:Kanglaite injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer patients with Qi and Yin deficiency is similar to chemotherapy in improving the efficacy of solid tumor;Kanglaite injection combined with chemotherapy can better improve patients’ Cartesian scores,improve patients’ physical status;The clinical symptoms can be alleviated by improving TCM syndrome score and lung cancer symptom score.The expression level of CYFRA21-1 was reduced,the myelosuppression and gastrointestinal reactions caused by chemotherapy were reduced,the total incidence of adverse reactions and the incidence of Grade 3 or above serious adverse reactions were reduced,and the combination medication did not aggravate the burden of liver and kidney function,with good safety and feasibility.Therefore Kanglaite injection combined with chemotherapy is a safe and effective treatment for advanced non-small cell lung cancer with deficiency of both Qi and Yin. |
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