| Malignant ascites(MA)is often secondary to the advanced stage of a variety of malignant tumors,with a short survival time and extremely poor prognosis.At present,there are various treatment methods of western medicine in clinical practice,but the efficacy is not good and side effects are great,which has become a major problem in modern medical treatment.The traditional Chinese medicine emphasizes treating the disease and seeking the root cause of the disease and treating according to syndrome differentiation,which achieves the purpose of "treating the disease and seeking the root cause" by the method of "syndrome differentiation and seeking the cause".The strengthening of the right side and eliminating the pathogenic factors are synchronized,and the treatment of the symptoms and the root cause is the same frequency.Objective:To observe the rotary Yang Yi gas side joint human recombinant endostatin(en)and cisplatin(DDP)scheme for MA,the clinical curative effect and safety of patients,in order to provide clinical basis for the treatment of MA.Methods:According to the inclusion and exclusion criteria,60 patients who met the requirements were randomly divided into two groups.The control group was given recombinant human endostatin(endostar)60mg/ time,and cisplatin 40mg/ time intraperitoneal perfusion,administration time was d1,d4,d7.The experimental group was treated with Fuyang Yiqi decoction on the basis of the control group,1 dose a day,divided into morning and evening,for 14 days.The changes of ascites volume before and after treatment in the two groups were recorded,and the objective response rate(ORR)was evaluated.The TCM syndrome scores and karnofsky performance status(KPS)scores of the two groups before and after treatment were recorded.And safety indicators,and the differences were compared.The progress free survival(PFS)of the two groups after treatment was recorded,and the factors affecting PFS were analyzed.P<0.05 was considered statistically significant.Results:1.Comparison of general data: before treatment,the gender,age,initial effusion volume,nature of effusion,tumor type,KPS score and TCM syndrome score of the two groups were compared,and the results were not statistically different,and the baseline was comparable.2.Short-term efficacy evaluation(ORR as the evaluation standard): the ORR of the experimental group was 83.33%,and that of the control group was 62.07%,the experimental group was better than the control group in the short-term efficacy of MA control,the difference was statistically significant(P < 0.05).3.Long-term efficacy evaluation(PFS as the evaluation standard): the median PFS of the experimental group was 73 days,and the median PFS of the control group was 57 days.The experimental group had an advantage in controlling the long-term efficacy of MA,and the difference was statistically significant(Logrank P < 0.05).Multivariate COX regression analysis showed that non-bloody effusion was a protective factor for PFS.4.TCM syndrome evaluation: the total effective rate of the experimental group was 92.97%,and the total effective rate of the control group was 71.23%.The experimental group had advantages in improving the clinical syndrome of TCM,and the difference was statistically significant(P< 0.05).5.Functional status(KPS)evaluation: there was no significant difference in KPS scores between the two groups after treatment(P > 0.05).The KPS scores of the two groups before and after treatment were compared,and the KPS scores of the two groups were statistically significant(P < 0.05).The results showed that the experimental group had no obvious advantage in improving the functional status of patients.6.Safety evaluation: there were no serious adverse reactions and related deaths in the two groups during and after the treatment.The adverse events were mainly G1 grade,which were improved after symptomatic treatment or drug withdrawal,and the safety was controllable.The adverse events caused by the drugs in this study were myelosuppression and gastrointestinal reactions.The incidence of myelosuppression and diarrhea events in the experimental group was lower than that in the control group,and the difference was statistically significant(P < 0.05).Conclusions:Self-made Fuyang Yiqi decoction combined with endodegree and cisplatin in the treatment of MA with spleen and kidney Yang deficiency is effective,which highlights advantages in short-term efficacy,long-term efficacy,and improvement of TCM clinical syndromes,and reflects a certain safety,which is worthy of clinical application. |
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