| Objective:This study mainly observed the clinical efficacy of Lishui Huoxue Decoction in the treatment of malignant pleural effusion,and evaluated the clinical symptoms,pleural effusion volume reduction,quality of life and safety of patients,in order to provide more safe and effective treatment and theoretical basis for the treatment of malignant pleural effusion with traditional Chinese medicine.Method:From January 2020 to February 2021,80 patients who visited the oncology clinic and ward of Second Affiliated Hospital of Tianjin University of TCM and diagnosed as malignant tumor with malignant pleural effusion confirmed by B-ultrasound were included into the study.The patients were randomly divided into treatment group(n = 40)and control group(n= 40).They were observed for 28 days.Both groups were given symptomatic support treatment.The control group was treated with furosemide 20 mg + spironolactone 20 mg bid orally for 28 days;on the basis of the treatment of control group,the other group’s treatment was added with Lishui Huoxue Decoction orally for 28 days.The pleural effusion volume,TCM syndrome score and Karnofsky score of the two groups were observed to compare the effective rate,TCM syndrome and quality of life of the two groups before and after treatment.The vital signs,blood routine,fecal routine,urine routine,electrolyte,liver function,renal function and adverse reactions were monitored to evaluate the safety of Lishui Huoxue Decoction in the treatment of malignant pleural effusion.Spss21.0 was used to analyze the data and compare the difference between the treatment group and the control group.Result:1.During the study,there were no shedding cases.80 cases were observed,including 40 cases in the treatment group and 40 cases in the control group.2.Baseline data: The age,gender,cancer type and pleural effusion volume before treatment of the treatment group and the control group were statistically analyzed,P>0.05,and the differences were not statistically significant,which can be compared.3.Efficacy of pleural effusion: Intra-group comparison: Compare the maximum depth of pleural effusion before and after treatment of the two groups.P=0.00 in the control group;P=0.013 in the treatment group.Both of them have significant differences in the amounts of pleural effusion before and after treatment.Both treatments are effective.Comparison between groups: The control group has an effective rate of 75%,and the treatment group has an effective rate of 87.5%.After testing,P<0.05,there is a significant difference between the groups.4.TCM syndrome score: Comparison within the group: Before and after treatment,P=0.00 in the control group and the treatment group is the same.The differences of the two groups are significant.Comparison between the two groups after treatment: The control group has an effective rate of 70%,when the treatment group’s is 82.5%.After testing,P<0.05,which means the difference of TCM syndromes between the two groups is significant.5.Analysis of the efficacy of quality of life: Intra-group comparison: Before and after treatment,the cassette scores were compared in the two groups,P=0.023 in the control group;P=0.001 in the treatment group,the quality of life of the two groups was significantly improved;comparison between the groups: the control group has an efficiency which is82.5%,and the effective rate of the treatment group is 90%.After inspection,P<0.05,and according to it,the life quality of the treatment group is much better than the other one and the difference is obvious.6.Safety evaluation: Before and after treatment,the blood routine,liver function,renal function,electrolyte and other biochemical indicators of the two groups were tested.Vital signs and adverse reactions were monitored during treatment.There was no obvious abnormality after testing.Conclusion1.Lishui Huoxue decoction is more effective than diuretics alone in reducing the pleural effusion volume.2.Lishui Huoxue decoction is better than diuretics alone in improving the quality of life of patients with malignant pleural effusion.3.Compared with diuretics alone,Lishui Huoxue Decoction can significantly improve the TCM syndrome score of patients with malignant pleural effusion.4.Lishui Huoxue decoction is safe in the treatment of malignant pleural effusion without obvious adverse reactions,which is worthy of clinical promotion. |