| Background:with the development of current science,there are more and more therapeutic methods for advanced NSCLC(Non-small cell lung cancer),such as molecular targeted therapy,immunotherapy,etc.,but the chemotherapy regimen containing platinum is still the first choice in NCCN guidelines for advanced NSCLC.With chemotherapy comes inevitable side effects,such as digestive tract reaction,bone marrow suppression,neurotoxicity,etc.chemotherapy-induced nausea and vomiting(CINV)are the most common symptoms of gastrointestinal side effects,which will not only affect the quality of life of patients,and even reduce the completion rate of chemotherapy,thus affecting the treatment effect of patients.Among them,delayed CINV within 24 hours to 7 days of chemotherapy.The treatment of acute chemotherapy-associated nausea and vomiting in modern medicine has a fast and stable effect,but the treatment of delayed nausea and vomiting is still insufficient.As a means of traditional medicine,traditional Chinese medicine plays an important role in alleviating side effects during chemotherapy.Poria Polysaccharide Oral Solution,as a preparation with auxiliary anti-tumor effect produced by Hunan Busky Pharmaceutical,is clinically used for the treatment of cancer patients with spleen and stomach qi deficiency caused by radiotherapy and chemotherapy.At present,there has been no relevant clinical research at home and abroad on whether Poria Polysaccharide Oral Solution can prevent delayed nausea and vomiting caused by chemotherapyObjective:To evaluate the effect of Poria Polysaccharide Oral Solution on the prevention of delayed nausea and vomiting in patients with non-small cell lung cancer during platinum-containing chemotherapy and to evaluate the safety of Poria Polysaccharide Oral Solution in patients with NSCLC during platinum-containing chemotherapyMethods:This study through the multicenter,randomized controlled design,stage into ?-IV NSCLC platinum-based chemotherapy patients,64 cases of the two drugs,34 cases were randomly divided into test group and control group 30 cases.Before the start of the experiment,SAS 9.4 statistical software PROC PLAN procedure statement was used to generate a random number table for 60 subjects to receive treatment for a given number of seeds,and grouping coding was carried out.Subjects who met the requirements were selected and enrolled according to the study protocol,and were randomly assigned to the experimental group or the control group for a 42-day observation period.The chemotherapy regimen was implemented in accordance with the NCCN clinical practice guidelines NSCLC2015.The experimental group was treated with cisplatin+paclitaxel/docetaxel chemotherapy for Q21d(d1-d3+paclitaxel 135-175mg/m2 d1).Cisplatin 25mg/m2 d1-d3+ 75mg/m2 d1-d3)at the same time,take Poria Polysaccharide Oral Solution 10ml/time,3 times a day,continuous use for 21 days;The control group only received cisplatin+paclitaxel/docetaxel chemotherapy for Q21d.After continuous use for 2 cycles,relevant scales and indicators were evaluated on day 7,day 21,day 28 and day 42,respectively.Evaluation criteria:incidence and degree of chemotherapy-related adverse reactions(nci-ctcae1.4.03),clinical symptom assessment scale(MDASI-TCM),quality of life questionnaire(qlq-c30),laboratory examination(blood routine,electrocardiogram,liver and kidney function examination).SAS9.4 version was used for analysis.Results:a total of 64 patients were included,and a total of 60 patients were completed,including 30 patients in the experimental group and 30 patients in the control groupMain efficacy indicatorsIncidence and severity of nausea and vomiting:1.NCI-CTCAE1.4.03:During the total treatment,there was no significant difference in the incidence of nausea and vomiting between the two groups,but the total incidence of vomiting in the experimental group was better than that in the control group.On the 28th day of treatment,the incidence of nausea in the experimental group was significantly higher than that in the control group(P<0.05),and the incidence of vomiting was significantly higher than that in the control group(P=0.054).On day 42 of treatment,the incidence of nausea was significantly higher in the experimental group than in the control group(P<0.05).On day 42,the incidence of vomiting was higher in the experimental group than in the control group,but there was no statistical difference between the two groups(P>0.05).In terms of the severity of nausea and vomiting,the incidence of grade 2 nausea in the experimental group was significantly better than that in the control group during the total treatment process,with statistical difference between groups(P<0.05).2.MDASI-TCM:On the 21st and 42nd day of treatment,nausea symptoms in the experimental group tended to be better than those in the control group,but there was no statistical difference between the groups(P>0.05).On day 21 and day 42,no significant difference was found between the experimental group and the control group(P>0.05).3.QLQ-C30:The difference value on the 21st day of treatment was 0.5±24.1 in the experimental group and 10.6± 18.8 in the control group,P=0.0666>0.05,indicating that the experimental group was superior to the control group.However,the difference between the two groups was not statistically significant,but there was a trend of difference.The difference value on the 42nd day of treatment was-3.1±28.2 in the experimental group and 5.6±24.5 in the control group,P=0.0978>0.05,showing no statistical significance between the two groups but a trend of difference.Secondary efficacy index1.Other symptoms of TraditionalRADITIONAL Chinese Medicine Symptom Scale(MDASI-TCM):on the 21st day of treatment,the improvement of 7 items,including restlessness in sleep,shortness of breath,forgetfulness,worst appetite,numbness,constipation,and enjoyment of life,was significantly better in the experimental group than in the control group(P<0.05).In terms of fatigue(fatigue)and distress,the experimental group was superior to the control group,but there was no statistical difference between the groups(P>0.05).On the 42nd day of treatment,among the 9 items of sweating,fatigue(fatigue),restlessness in sleep,shortness of breath,forgetfulness,sadness,constipation,irritability,coldness of life,the improvement of the experimental group was significantly better than that of the control group(P<0.05).In terms of the worst appetite and mood,the experimental group was superior to the control group,but there was no statistical difference between the groups(P>0.05).2.Total score:there was no statistical difference in the sum of TCM symptom scores between the two groups on day 21 and day 42(P>0.05);However,the total score difference between the two groups on day 21 and day 42(before and after)was significantly better in the experimental group than in the control group(P<0.05).It indicates that tuckahoe polysaccharide oral liquid has a certain tendency in improving the expected nausea symptoms,but the advantage is not significant.It has obvious advantages in improving the symptoms of temper deficiency caused by chemotherapy.3.Quality of Life score(QLQ-C30)Other fields and individual conditions:On the 21st day of treatment,the experimental group was significantly better than the control group in the functional scale-role function and functional scale-somatic function fields(P<0.05);On the 42nd day of treatment,the experimental group was significantly better than the control group in terms of functional scale-emotional function,functional scale-overall life,functional scale-somatic function,monomial-shortness of breath,monomial-decreased appetite(P<0.05).Functional scale-role function and functional scale-cognitive function,the experimental group had a better trend than the control group,but the difference between the two groups was not statistically significant(P>0.05).The results showed that tuckahoe polysaccharide oral liquid had a tendency to prevent the expected nausea and vomiting,but the advantage was not obvious.It has obvious advantages in improving the quality of life and spleen deficiencies-related symptoms(shortness of breath,decreased appetite)Safety evaluationExcept for the adverse reactions recorded in the NCI adverse reaction scale,4 cases(1 1.8%)of the experimental group had adverse events,and 6 cases(20%)of the control group had adverse events,which were judged to be unrelated to the experimental drugs,and P>0.05,showing no statistical significance between the two groups.No other adverse reactions were recorded.Conclusion:Poria Polysaccharide Oral Solution has a significant advantage in preventing delayed nausea caused by chemotherapy containing platinum,and can improve the severity of nausea.It has a certain tendency in preventing and improving delayed vomiting and expected nausea and vomiting during chemotherapy,but the improvement effect is not significant.Poria Polysaccharide Oral Solution has a significant advantage in improving the symptoms of spleen qi deficiency caused by chemotherapy.Poria Polysaccharide Oral Solution has obvious advantages in improving the quality of life and TCM syndromes of patients with chemotherapy.Poria Polysaccharide Oral Solution treatment is safe and suitable for clinical promotion. |
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