| Background and objectiveChemotherapy,as one of the main treatment methods for malignant tumors,is accompanied by varying degrees of adverse reactions while improving the survival outcome and quality of life of patients,among them,nausea and vomiting are the most common gastrointestinal side effects in chemotherapy patients.Chemotherapy-induced nausea and vomiting（CINV）refers to nausea and vomiting caused by chemotherapy drugs in the course of chemotherapy.Most patients have experienced CIN V to varying degrees in the process of chemotherapy.Severe nausea and vomiting will lead to water and electrolyte disturbance and nutritional imbalance in patients,which can reduce the quality of life and chemotherapy tolerance of patients.Even some patients give up chemotherapy due to mental fear,which directly affects the survival and prognosis of tumor patients.According to the emetogenic risk,chemotherapy drugs are divided into high,moderate,low and mild emetogenic chemotherapy drugs.Cisplatin is a highly emetogenic chemotherapy drug.In chemotherapy regimens containing high emetogenic chemotherapy drugs,the incidence of nausea and vomiting is as high as 90%without any preventive antiemetic treatment.According to the clinical practice guide for NCCN antiemetic（2018 edition）,the recommended drug regimen for CINV caused by highly emetogenic chemotherapy regimen is NK-1 receptor antagonist,olanzapine,5-HT3receptor antagonist and dexamethasone.At present,NK-1 receptor antagonist（NK-1RA）has been listed in the domestic market of China.However,due to the high price of this antiemetic drug in the market,many patients cannot afford it economically,which limits the widespread use of NK-1RA in clinical practice.This study by comparing the Olazapine with metoclopramide combined ondansetron and dexamethasone the clinical curative effect and security of prevention and treatment of nausea and vomiting associated with chemotherapy includingCisplatin,for providing a economic treatment scheme for clinical prevention of CINV caused by chemotherapy regimens including cisplatin,so as to improve chemotherapy tolerance and quality of life of malignant tumor patients treated with chemotherapy regimens including cisplatin.MethodsThis study was a prospective,randomized,controlled study.There were 66 patients with malignant tumors receiving chemotherapy regimens including cisplatin,a total of 152 cycles of chemotherapy（1 patient withdrew from the trial due to severe drowsiness reaction）.This study has successfully passed the ethical review of the medical ethics committee of hunan people’s hospital（scientific research ethics approval no.[2018]-01.1）.All patients entering the clinical trial had signed the informed consent.All patients were randomly divided into three groups according to the random number table method,namely,olanzapine group,metoclopramide group and Olanzapine combined with metoclopramide group.All patients were given ondansetron 8mg intravenous drip d1before and after chemotherapy,and dexamethasone 10mg intravenous drip d1+8mg oral qd d2-4 before chemotherapy.In addition,Olanzapine group was given olanzapine 10mg,d1-d4 once a day.Metoclopramide group was given 10 mg,d1-d4,three times a day.Olanzapine combined with metoclopramide group was administrated with olanzapine（10mg,d1-d4,once a day）and metoclopramide（10mg,d1-d4,three times a day）.The complete remission rate and effective rate of acute phase CINV and delayed phase CINV were compared among the three groups,and the incidence of explosive vomiting and the average score of nausea and vomiting symptoms were compared among the three groups,so as to evaluate the clinical efficacy and safety of three different schemes for the prevention and treatment ofnausea and vomiting associated with chemotherapy including cisplatin.Results1.There were 19 patients in the olanzapine group with 49 cycles of chemotherapy,25 patients in the metoclopramide group with 52 cycles of chemotherapy,and 21 patients in the olanzapine combined with metoclopramide group with 50 cycles of chemotherapy.The general clinical data of the three groups showed no statistical difference（P>0.05）,which were comparable.2.The mean score of nausea and vomiting in the olanzapine group（2.629±1.402）and the mean score of nausea and vomiting in the olanzapine combined with metoclopramide group（2.288±1.189）was lower than that in the metoclopramine group（4.362±2.049）,with statistically significant differences（P<0.001 and P<0.001,respectively）.There was no significant difference between the olanzapine group and the olanzapine combined with metoclopramide group（P=0.130）.3.There was no statistical difference in the complete response rate（83.67%78.85%74.00%,P=0.500）and effective rate（97.96%98.08%100%,P=0.770）of CINV in the acute phase（0-24h）among the three groups.The complete remission rate of CINV in the delayed phase（24-120h）in the olanzapine group was higher than that in the metoclopramide group（38.78%vs 5.77%,P<0.001）,and the effective rate of CINV in the delayed phase in the olanzapine group was higher than that in the metoclopramine group（97.96%vs 48.08%,P<0.001）with statistical differences.The complete response rate（32.00%）and the effective rate（98.00%）of the delayed phase（24-120h）CINV in the olanzapine combined with metoclopramide group were higher than those in the metoclopramide group（P=0.001,P<0.001,respectively）and the differences were statistically significant.There were no statistically significant differences in the complete response rate and effective rate of the delayed CINV between the olanzapine group and the olanzapine combined with metoclopramide group（P=0.481,P=1,respectively）.The total（0-120h）CINV complete response rate in the olanzapine group was higher than that in the metoclopramide group（34.69%vs 3.85%,P<0.001）,and the total CINV effective rate in the olanzapine group was higher than that in the metoclopramide group（97.96%vs 46.15%,P<0.001）with statistical differences.The total（0-120h）CINV complete response rate（30.00%）and effective rate（98.00%）of olanzapine combined with metoclopramide group were higher than that of metoclopramide group（P<0.001 and P<0.001,respectively）and the differences were statistically significant.There was no statistically significant difference in the total CINV complete response rate and effective rate between the olanzapine group and the olanzapine combined with metoclopramide group（P=0.618,P=1,respectively）.4.The incidence of explosive vomiting in olanzapine group（10.20%）and olanzapine combined with metoclopramide group（18.00%）was significantly lower than that in metoclopramine group（73.08%）（P<0.001 and P<0.001,respectively）,and the difference was statistically significant.There was no significant difference between olanzapine group and olanzapine combined with metoclopramide group（P=0.266）.5.The incidence of drowsiness in olanzapine group（87.76%）and olanzapine combined with metoclopramide group（92.00%）was higher than that in metoclopramine group（28.85%）（P<0.001 and P<0.001,respectively）and the difference was statistically significant.There was no statistically significant difference in the incidence of sleepiness between the olanzapine group and the olanzapine combined with metoclopramide group（P=0.525）.There was no statistically significant difference in the incidence of constipation,insomnia,fatigue and dizziness among the three groups（P>0.05）.Conclusions1.The efficacy of metoclopramide combined with dexamethasone and ondansetron for the prevention and treatment of acute phase CINV induced by cisplatin chemotherapy is similar to that of olanzapine combined with ondansetron and dexamethasone.2.Compared with the regimen of metoclopramide combined with ondansetron and dexamethasone,the regimen of olanzapine combined with dexamethasone and ondansetron has a better control effect on the delayed CINV caused by chemotherapy regimens including cisplatin.The adverse reactions of sleepiness were increased,but there was no significant increase in the adverse reactions of dizziness,fatigue,constipation,insomnia.3.Compared with the triple regimen of olanzapine combined with ondansetron and dexamethasone,the addition of metoclopramide cannot enhance the prevention and treatment effect of CINV caused by cisplatin-containing chemotherapy regimens.4.The antiemetic regimen of olanzapine combined with ondansetron and dexamethasone has obvious advantages in clinical efficacy,safety and economic feasibility,and is worthy of clinical promotion.. |
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