| Objective:The purpose of this research is to observe the clinical efficacy and safety of Liqi Huayu Decoction combined with TP chemotherapy in the remedy of advanced esophageal cancer(EC),in order to enhance the efficacy and clinical symptoms of EC patients through traditional Chinese medicine(TCM),and afford more clinical basis for the remedy of EC with TCM.Methods:The randomized control principle was followed in this research,and 72 patients who met the inclusion criteria were assigned to the experimental group(n=36)and the control group(n=36).The experimental group received Liqi Huayu Decoction combined with TP chemotherapy,while the control group received TP chemotherapy alone.Observe the extent of tumor,changes of tumor markers SCC,CEA,improvement of TCM clinical symptoms,KPS scores and other indicators before and after therapy in the two groups to evaluate the clinical efficacy of Liqi Huayu Decoction in the remedy of patients with advanced EC.The safety of the experiment was evaluated by the changes of patients’ blood routine test,liver and kidney function and occurrence of adverse events during the trial.Results:One case fell out of the test group and the control group,and 70 cases were included in the final group,with 35 cases in each group.1.Efficacy evaluation of solid tumor:The tumor size of the experimen-tal group and the control group was evaluated before and after treatment,and the results showed that there was no statistical significance in the ORR(Objective response rate)and DCR(Disease control rate)between the two groups(P>0.05).2.Clinical symptoms of TCM: The clinical symptoms of the experimental group and the control group were 88.57% and 74.28%,,respectively,with statistical difference(P<0.05).Intra-group contrast:After treatment,the scores of eight TCM symptoms of experimental group were reduced compared with before,with statistical difference(P<0.05),and the results were significant in dysphagia,sputum salivation and appetite loss(P<0.001),while the scores of control group were statistically significant in dysphagia,sputum salivation and fatigue(P<0.05).Contrast between groups: After remedy,scores of TCM symptoms in experimental group were lower than those in control group,and improvements in dysphagia,loss of appetite,abdominal distension and distress were significantly better than those in control group(P<0.05).3.KPS score and weight: After treatment,the KPS score of the experimental group was higher than the control group,and the difference was statistically significant(P<0.05);The weight of the two groups elevated after remedy,but there was no statistical difference(P>0.05).4.Tumor makers: The levels of CEA and SCC in the two groups reduced after remedy compared with those before remedy,and there was no statistical difference between two groups(P>0.05).The level of SCC in the experimental group was higher than that in the control group(P<0.05),and the difference was statistically significant.5.Safety evaluation: The number of cases with leukocytopenia after remedy in experimental group was less than that in control group(P < 0.05),and difference was statistically significant.There was no statistical significance in the reduction of HGB and PLT and abnormal liver and kidney function between the two groups(P>0.05),indicating that Liqi Huayu decoction had well safety and no side effects in this trial.Conclusion:Through clinical observation,Liqi Huayu Decoction combined with TP chemotherapy has a satisfactory effect on the clinical symptoms of TCM in patients with mid to late stage EC of phlegm qi stasis type.It can also improve the patient’s KPS scores,improve their quality of life,reduce the occurrence of white blood cell reduction,and have good safety.It has continued promotion value in the treatment of mid to late stage EC. |
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