Clinical Observation Of Comparing The Efficacy Of Three-drug Regimens Containing Olanzapine/Dexamethasone In Preventing Hyperemetic Chemotherapy-induced Nausea And Vomiting (CINV)

BackgroundChemotherapy is one of the indispensable treatments for malignant tumors,and chemotherapy-induced nausea and vomiting(CINV)is one of the most common adverse reactions.For patients who apply the highly emetic chemotherapy regimen,the authoritative anti-emetic guidelines in China and abroad recommend the combination of multiple drugs to prevent and treat CINV,but the combination drugs contain dexamethasone,and many side effects caused by dexamethasone cannot be ignored.The guidelines of national comprehensive cancer network(NCCN)clearly point out that multi-drug antiemetic plan containing olanzapine can effectively prevent CINV,and propose that olanzapine can be used as a substitute of antiemetic for cancer patients who cannot apply dexamethasone,and can improve the quality of life of patients.Besides,there is no clinical study on the complete without dexamethasone combined with antivomiting regimen in China and abroad.Objective1.To confirmed that the triple antiemetic regimen containing olanzapine can effectively prevent CINV caused by hyperemetic chemotherapy regimen;2.Comparison of the effects of two antiemetic regimens on the improvement of anxiety,depression,and sleep quality in patients;MethodsIn this study,the randomized,open-label,parallel-controlled trial method was adopted,and the random number table was used for simple random grouping.The subjects were randomly assigned to the experimental group or the control group in a 1: 1ratio.A total of 50 inpatients with malignant tumor who received the hyperemesis chemotherapy regimen in the First Affiliated Hospital of Xinxiang Medical College from April 2020 to January 2021(who completed the clinical experiment and the follow-up visit)were included in the study and randomly assigned to the control group or the experimental group according to the random number table.The control group was given the traditional triple antiemetic regimen containing dexamethasone(dexamethasone combined with fosaprepitant meglumine and palonosetron),and the experimental group was given the triple antiemetic regimen containing olanzapine(olanzapine combined with fosaprepitant meglumine and palonosetron).The degree of nausea was assessed with visual analogue scale(VAS)from the day of chemotherapy.The complete response rate of nausea and vomiting in the acute phase,the delayed phase and the total observation phase were calculated,respectively.According to the nausea and vomiting scores,the patients were divided into a nausea group,a non-nausea group,and a vomiting group and a non-vomiting group.The anxiety and depression states of all patients before and after treatment were evaluate by SAS and SDS.The improvement of sleep quality before and after treatment was assessed by The total sleep disorder scale(GSDS),and the fasting blood glucose of the patients from one day before the start of chemotherapy to the day after chemotherapy was ended.The effects of experimental group and control group on blood glucose were analyzed,and the ratios(rates)of increased blood glucose and non-increased blood glucose in each group were calculated according to whether the blood glucose was increased or not.The proportion(rate)of treatment intervention group and treatment intervention group was calculated in the hyperglycemia group.Adverse drug reactions were documented in detail during the study and assessed by grade according to CTC-AE version 4.03 adverse event grade.Results1.The complete remission rates(CR)of nausea in the general observation period,acute period and delayed period in 25 patients of the control group were 40%,80% and64%,respectively,while those in the experimental group were 55.6%,84% and 76%,respectively.There was no significant difference in the complete remission rates of nausea between the control group and the experimental group in the total observation period,the acute period and the delayed period(P > 0.05).2.The complete remission rates(CR)of emesis in the observation,acute and delayed phases in 25 patients of the control group were 92%,100% and 92%,respectively,while the CR of emesis in the observation,acute and delayed phases in 25 patients of the experimental group were 88%,96% and 92% respectively.There was no obvious difference in the complete response rates of vomiting between the control group and the experimental group in the total observation period,the acute period and the delayed period(P > 0.05).3.In the control group,the difference in anxiety(SAS)score before and after chemotherapy was statistically significant,while there was no significant difference in depression(SDS)score before and after chemotherapy.SAS and SDS scores of patients in experimental group before and after chemotherapy had significant differences.In the control group,the anxiety(SAS)scores of patients with nausea were not significantly different from those of patients without nausea,and the SDS score of patients with nausea was significantly different from that of patients without nausea.Further analysis of the correlation showed a significant correlation(P < 0.05)between SDS score and nausea,with a positive correlation.There was no significant correlation between vomiting and SAS or SDS scores in the control group.In the experimental group,SAS and SDS scores had no correlation with nausea and vomiting.4.In the analysis of adverse reactions,it was found that only five of the 50 patients in this study were combined with type 2 diabetes,and all five patients were in the control group.We observed that the blood glucose levels of all five patients were increased to different degrees during the current chemotherapy cycle.5.A total of 19 patients were at risk for sleep disorders,including 7 patients in the control group and 12 patients in the experimental group.At the end of the study,the sleep quality of patients at risk of sleep disorders in the control group was not significantly improved,while that of patients at risk of sleep disorders in the experimental group was improved 100%.The sleep quality scores before and after chemotherapy were statistically significant(P<0.05),and no significant adverse reactions were observed during the observation period.Conclusion1.The three-drug regimens of “olanzapine + palonosetron + fosaprepitant” can effectively prevent CINV caused by hyperemetic chemotherapy,which is equivalent to the effect of traditional three-drug regimens containing dexamethasone for preventing CINV.2.Olanzapine improves anxiety,depression and sleep quality in patients with malignant Tumor.