| Objective: To observe and explore the clinical efficacy and safety of a combination of Jiedu Sanjie Decoction with Anlotinib in the treatment of patients with advanced nonsmall cell lung cancer,and to provide a reference to the combined Western and Chinese medicine treatment of advanced non-small cell lung cancer.Methods: Sixty cases of advanced non-small cell lung patients who met the inclusion criteria were included.According to the time of enrollment,the patients was divided into test group and control group by the random number method,with 30 cases in each group.The control group was given Anlotinib Hydrochloride Capsules once a day,12 mg once a day,orally before breakfast,for 14 days,and then stopped for 7 days,and during the period,adverse reactions were promptly treated.In the test group,the Jiedu Sanjie Decoction soup was added to the control group,and one dose was taken daily,and after decoction,take 300 ml of the liquid and divide it into portions half an hour after breakfast and dinner.Both groups were treated with 21 days as a treatment cycle,and the changes of each index were recorded before and after the completion of 2 treatment cycles,respectively.The specific indicators are: solid tumor efficacy evaluation,TCM symptom score,KPS score,HAMD score,tumor markers,immune function,adverse reaction evaluation.Results:(1)Short-term efficacy evaluation: There was no statistically significant difference in the short-term efficacy between the test group and the control group(P>0.05).The ORR was the same in both groups,but the DCR of the test group(73.33%)was higher than that of the control group(66.67%).(2)Efficacy evaluation of TCM symptoms: The total effective rate of the test group and the control group were 66.67 %and 26.67%,respectively,and the statistically difference was obvious in comparison(P<0.05).The test group improved the symptoms of cough,dry mouth and dry throat more significantly,and the difference between the groups was highly statistically significant(P<0.01).(3)KPS score: The effective rate of the test group was 70.00%,higher than that of the control group(43.33%),and the difference was statistically significant(P<0.05).(4)HAMD score: After treatment,the total score of depressive state the test group was lower than that in the control group,the difference was statistically significant(P<0.05);The improvement of depression status was similar in both groups.(5)Evaluation of tumor markers: The CEA and CY21-1 indexes were lower than those before treatment in both groups,and the difference before and after treatment was significant(P<0.05).There was no significant difference between the two groups(P>0.05).(6)Evaluation of immune function indicators: After treatment,there was a statistically significant difference between the two groups in the levels of immune function indexes CD3+,CD4+,CD8+,CD4+/CD8+,etc.(P<0.05);Intra-group comparison: There was a significant difference before and after treatment in the test group(P<0.05),and the control group’s results were similar(P>0.05).(7)Evaluation of adverse reactions: There was no statistical significance between the test group and the control group difference in blood routine,liver function,renal dysfunction,bleeding,hypertension,hand-foot syndrome,proteinuria and other adverse reactions(P>0.05).The incidence of fatigue,diarrhea,nausea and vomiting in the test group was significantly lower than that in the control group(P<0.05).Conclusion: The combination of Anlotinib and Jiedu Sanjie Decoction in the treatment of advanced NSCLC can improve the clinical TCM symptoms and depression status of patients,improve the patients’ quality of life and enhance the body ’s immunity,reduce the incidence of adverse reactions such as diarrhea,nausea and vomiting,and fatigue.It is worthy of clinical application. |
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