| Objective: Evaluate the effects and safety of Yiqi tongluo jiedu decoction combined with TP regimen in the treatment of Ⅲ-ⅣEC with qi-asthenia causing blood-stasis and phlegm-obstruction,which are to give evidence for the clinical applications.Methods: According to a randomized method,eligible patients were divided into a control group and a treatment group.38 patients were included in the treatment group and 40 patients in the control group.The former was addressed in TP chemotherapy and chinese herb decoction.The latter was given TP chemotherapy alone.Both groups were treated for 2 cycles.Key observations as follows: Clinical syndrome of Traditional Chinese Medicine TCM,Karnofsky,Adverse reactions and Short-term effects;Secondary observations:Safety indicators.Results: 1.Baseline analysis of 2 groups in age,gender,stage and pathological type,which was no significant difference(P>0.05);2.Clinical syndrome score of TCM: There were no significant differences between the two groups before treatment,after treatment,scores of both groups were decreased(P<0.05).The treatment group was better than the control group(P<0.05);3.Score of Karnofsky: Before treatment,there was not any statistical significance between two groups.When compared with those before treatment,the KPS increased and the treatment group was better than the control group(P<0.05);4.Chemotherapy-related hair loss: Before and after treatment,the difference had no statistical significance(P>0.05);Myelosuppression: White blood cell and platelet had no statistical significance before treatment,after treatment,the treatment group was better than the control group(P<0.05);Digestive tract reaction: Before treatment,there was no statistical difference between two groups of vomiting,after treatment,the treatment group was better than the control group(P<0.05);Peripheral neurotoxicity: Both groups of anaesthesia had no statistical difference before treatment,after treatment,the treatment group was better than the control group(P<0.05).5.Short-term effects: Before and after treatment,Objective tumor remission rate and disease control rate of both groups had no significant difference(P>0.05).6.Secondary observations: After treatment,there was a statistical difference between two groups of blood routine the,the treatment group was better than the control group(P<0.05);For liver function、kidney function and electrocardiogram,there was no significant difference(P>0.05).Conclusion: Yiqi tongluo jiedu decoction combined with TP regimen in the treatment of III-IV EC with qi-asthenia causing blood-stasis and phlegm-obstruction can significantly improve the patients’ clinical symptoms,improve the quality of life of patients,reduce the chemotherapy related toxicity level,and has no obvious side effects,it is well worth applying in clinical. |