| ObjectiveThrough prospective randomized controlled experimental method,this study observed the situation of chemotherapy induced nausea and vomiting(CINV)in breast cancer patients,its influence on functional life and the symptoms of gastrointestinal diseases in traditional Chinese medicine.We evaluated the effects of licorice heart-draining decoction combined with antiemetic regimen and antiemetic regimen alone in delayed nausea and vomiting induced by chemotherapy in patients with cold-heat mixed type.Explore the efficiency and safety and also provide reference for clinical application.MethodsThis study enrolled 62 breast cancer patients receiving adjuvant chemotherapy with AC regimen(pirarubicin+cyclophosphamide)from June 2018 to January 2019 in the Department of breast cancer of the Second Traditional Chinese Medicine Hospital of Guangdong Province.The patients were randomly divided into treatment group and control group by random number method.The control group received 8 mg ondansetron and 60mg omeprazole sodium intravenously 30 minutes before and after chemotherapy,10 mg dexamethasone intravenously once,and 8 mg ondansetron intravenously the next day after chemotherapy for 4 consecutive days.The treatment group began to take licorice heart-draining decoction on the basis of the control group on the day of chemotherapy for 5 consecutive days.The recorded data included:1.Baseline data of age,height,weight,body surface area and KPS score;2.MASCC antiemetic tool score were recorded 24 hours and 4 days after chemotherapy;3.Functional Living Index-Emesis(FLIE)score were recorded 4 days after chemotherapy;4.TCM stomach symptoms score were recorded 24 hours,48 hours and 72 hours after treatment;5.Safety indicators such as blood tests,liver and kidney function were measured before and 4 days after chemotherapy.Using EXCEL to manage the data,using SPSS 22.0 to establish the database and analyze the data.Metrological data are expressed by means of standard deviation(x±s).The mean values between the two groups were compared by independent sample t/t' test.First,the homogeneity of variance F test was performed.If the variance was homogeneous,the t test was used and if not,the t' test was used instead.All non-normal distribution measurements were expressed by mean rank(R)and quartile(P25,P50,P75).The comparison of non-normal distribution measurements,small sample(n<50)composition ratio and rank data median was expressed by frequency(f),composition ratio or percentage(P)and average rank(R),and the comparison of median between the two groups was performed by Mann-Whitney U nonparametric test.Non-normal measurement,counting or grade data of secondary measurement are tested by self-pairing test.Test level:a=0.05.Results1.According to MAT,?in terms of vomiting,nobody occurred within 24 hours after chemotherapy in both groups.Compared with the control group,the effective rate of vomiting in the treatment group was significantly different after 24 hours(P<0.05).Compared with 24 hours,the effective rate of vomiting in the two groups was significantly reduced(P<0.01).In the frequency of vomiting,there was a significant difference between the two groups(P<0.05).It shows that the effect on delayed vomiting of the treatment group is better than the control group.?In terms of nausea,the effective rate in 24 hours in the treatment group was significantly lower than that in the control group(P<0.01);the effective rate in the treatment group was signi ficantly higher after 24 hours(P<0.01).Compared with the control group,the degree and the difference of nausea decreased significantly after 24 hours(P<0.01).Compared with 24 hours after chemotherapy,there was no significant difference in the degree of nausea 24 hours after chemotherapy in the treatment group(P>0.05),but significantly increased in control group 24 hours after chemotherapy(P<0.05).The results showed that the incidence of' nausea in the treatment group was higher than that in the control group within 24 hours.The incidence of nausea in the control group Was higher than that in the treatment group after 24 hours.The degree of nausea in the control group was higher after 24 hours.It can be concluded that licorice heart-draining decoction can better reduce the incidence of delayed nausea symptoms and alleviate nausea.2.In terms of functional living,involove vomiting,compared with the control group,"10,the degree of vomiting","14,enjoy the drink" "15,coexist with relatives and friends" "17,the difficulties for individual" had significant differences(P<0.05),the item "13,enjoy food" has increased significantly(P<0.01)of the treatment group.?In the nausea aspect,compared with the control group,the difference of the item "3,cooking or handling easy housework ""8,the difficulty for individual" was significant(P<0.05),and"1,the degree of nausea" was decreased significantly(P<0.01).It shows that licorice heart-draining decoction improves the quality of life of patients by improving the symptoms of nausea and vomiting and reducing its impact on life.3.In terms of TCM symptoms of gastrointestinal diseases,?compared with the control group,the scores of 24 hours,48 hours and 72 hours after chemotherapy in the treatment group were significantly different(P<0.01).Compared with 24 hours after chemotherapy,the total score of 48 hours and 72 hours was significantly different between the two groups(P<0.01),and the total score of 24 hours in treatment group was higher than control group,and the total score of 48 hours and 72 hours was significantly higher than that of the control group.The total score of the treatment group decreased significantly,while that of the control group increased.? Compared with the control group,the symptoms of the treatment group"nausea and vomiting","loss of appetite","abdominal distention after eating","belching","regurgitation","dry mouth",salivation " in the treatment group were more obvious in 24 hours after chemotherapy,but the symptoms of"nausea and vomiting" and "fullness","loss of appetite"","acid regurgitation","belching","regurgitation","hiccough","heartburn or burning sensation","clearing saliva "were alleviated(P<0.05).In the treatment group,compared with 24 hours after chemotherapy,the symptoms of "regurgitation","loss of appetite","abdominal distention after eating","belching","salivation","mental fatigue" were alleviated at 48 hours.Compared with 24 and 48 hours after chemotherapy,the symptoms of"difficulty in defecation,"constipation" were aggravated at 72 hours after chemotherapy,and other symptoms were alleviated to varying degrees.To sum up,it shows that licorice heart-draining decoction can improve delayed vomiting and related gastrointestinal diseases 48 hours after chemotherapy,especially for fullness,loss of appetite,postprandial abdominal distention,belching,regurgitation,heartburn or burning sensation,and other related gastrointestinal symptoms have different degrees of relief.But it may be due to the excessive spicy of dried ginger in the prescription,resulting the difficulty in defecation and constipation.4.In terms of safety indicators,there was no significant difference in the levels of WBC,NE%,HGB,PLT,ALT,AST,CR and BUN between the two groups before and on the forth day after chemotherapy.The results showed that licorice heart-draining decoction had no significant effect on the levels of WBC,RBC,HGB,PLT,NE%,ALT,AST,CR and BUN.ConclusionLicorice heart-draining decoction combined with antiemetic regimen can better control delayed CINV of cold-heat complex type,reduce the impact of nausea and vomiting on patients' functional life,and improve related gastrointestinal symptoms such as stomach fullness,loss of appetite,postprandial abdominal distention,belching.In summary,licorice heart-draining decoction can alleviate the delayed CINV of cold-heat complex type of breast cancer to a certain extent,which is convenient and feasible,and it is worth further application in clinical practice. |
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