Randomized Controlled Study On Efficacy And Safety Of Domestic Palonosetron Hydrochloride In Prevention Of Nausea And Vomiting Induced By Chemotherapy

Objective:To observe and assess the efficacy and safety of palonosetron hydrochloride injection made by Chongqing LaiMei Drug Limited Company for preventing nausea and vomiting caused by moderate or high emetic risk chemotherapy through comparing with tropisetron hydrochloride injection.Methods:This is a randomized,two-blinded,positive and own controlled clinical trial.Histological confirmed malignant patients who were willing and qualified to take part in this clinical test all received moderate or high emetic risk chemotherapy.Patients were assigned to group AB and BA randomly to receive a single dose of palonosetron 0.25mg made by Chongqing LaiMei Drug Limited Company(treatment drug) or tropisetron 5mg(control drug) 30min before initiation of moderate or high emetic risk chemotherapy.To observe the nausea and vomiting episodes and other antiemetic related adverse effects within 5 days after chemotherapy.Results:A total of 24 patients were enrolled and only 18 patients can be evaluated:9 in group AB and 9 in group BA.These 18 patients all used high emetic risk chemotherapy:7 receiving cisplatin and 11 receiving adriamycin or pharmorubicin.For palonosetron hydrochloride injection made by Chongqing LaiMei Drug Limited Company and tropisetron hydrochloride injection:the complete control rate of nausea in 24 hours after chemotherapy(acute nausea) was 11.1%and 0%respectively,the complete control rate of nausea between 25 to 120 hours after chemotherapy(delayed nausea) was 22.2%and 11.1% respectively,the efficacy control rates of nausea between 0 to 24 hours and between 25 to 120 hours after the treatment were both 55.6%and 44.4% respectively,the complete control rate of vomiting in 24 hours after the treatment(acute vomiting) was 33.3%and 16.7%respectively,the complete control rate of vomiting between 25 to 120 hours after the treatment(delayed vomiting) was 50.0%and 33.3%respectively,the efficacy control rate of vomiting in 24 hours after the chemotherapy was 66.7%and 50.0%respectively, there were all no significant differences between the two drugs(P＞0.05);The efficacy control rate of vomiting between 25 to 120 hours after chemotherapy was 88.3%and 50.0%respectively,there was significant difference between the two drugs(P=0.031),The side effects of the two drugs:5.56%experienced constipation(2 grade),2.78%headache(slight),2.78%dizziness(slight), 2.78%diarrhea(2 grade),no serious adverse event happened,there was no significant difference between the two drugs(P＞0.05)Conclusion:For high emetic risk chemotherapy:palonosetron hydrochloride injection made by Chongqing LaiMei Drug Limited Company is similar to tropisetron hydrochloride injection for preventing nausea and acute vomiting, but is superior to tropisetron hydrochloride injection for preventing delayed vomiting,and has few and mild side effects.