Olanzapine-based Quadruple Or Triple Antiemetic Regimens For Prevention Multi-day Cisplatin Chemotherapy Induced-nausea And Vomiting:A Prospective Randomized Controlled Clinical Trial

Objective:For patients receiving cisplatin multi-day chemotherapy and given olanzapine combined with neurokinin 1 receptor antagonist(NK-1 RA),serotonin 3 receptor antagonist(5-HT3 RA),dexamethasone quadruple antiemetic regimen or olanzapine combined with5-HT3 RA and dexamethasone triple antiemetic prospective randomized controlled clinical study to compare the two regimens in chemotherapy-induced nausea and vomiting(CINV).Compare the effectiveness,safety,and cost-effectiveness of the two regimens in the prevention and treatment of chemotherapy-induced nausea and vomiting(CINV).Methods:Prospectively randomized patients who received cisplatin for multiple days(in three days)were randomly divided into two groups,respectively receiving olanzapine combined with NK-1 RA,5-HT3 RA,dexamethasone quadruple antiemetic regimen or olanzapine combination 5-HT3 RA,dexamethasone triple antiemetic program.The main evaluation index is the total response time(acute phase + delayed phase)(0~120 h)complete response rate(CR).Complete response is defined as severe nausea without vomiting and no rescue measures after chemotherapy;the secondary index is CR rates in the acute phase(0-24 h)and delayed phase(25-120 h);Kaplan-Meier curve was used to compare the time when the first vomiting occurred in the two groups;The FLIE scale evaluates the impact of CINV on the quality of life of patients;evaluates the related adverse reactions of olanzapine and aprepitant;the economic cost of antiemetic drugs per cycle in the quadruple antiemetic program group compared with the triple antiemetic program group.Results:(1)The CR rate of the main evaluation indicators in the total period of the quadruple group is slightly better than that of the triple group 76.0%(45/59)vs 67.0%(41/61)(P=0.271); the secondary indicators CR in the acute phase and delayed phase The rates were 100.0%(59/59)vs 93.0%(57/61)(P=0.045),76.0%(45/59)vs 67.0%(41/61)(P=0.271);(2)FILE amount the score value calculated in the table is greater than 108 points,indicating that CINV has no effect on the patient’s quality of life.The quadruple group in this study is equivalent to the triple group,47.5%(28/59)vs 44.3%(27/61)(P=0.725)(3)The first vomiting of the quadruple group occurred later than the triple group(P=0.031);(4)the related adverse reactions of olanzapine were mainly drowsiness,and aripipan was mainly fatigue and constipation;(5)triple the group has better economic effect than the quadruple group.Conclusion:(1)The triple antiemetic regimen is equivalent to the quadruple antiemetic regimen in preventing CINV caused by cisplatin divided administration.It is safe and tolerable with a high cost-benefit ratio,which is beneficial to clinical promotion.(2)The triple antiemetic program is equivalent to the quadruple antiemetic program in improving the patient’s quality of life.(3)For patients with refractory vomiting or many risk factors,it is still recommended to use the quadruple antiemetic regimen,which can significantly reduce the incidence of vomiting.