BACKGROUND:Cisplatin has remarkable anti-tumor effects against various malignancies. Of its severe adverse reactions, nausea and vomiting are considered to be dose-limiting factors in cisplatin therapy. The anti-emetic properties of 5-HT₃ receptor antiagonists, such as ramosetron, can reduce nausea/vomiting. In order to evaluate the clinical efficacy of ramosetron injection against nausea and vomiting in treatment of cisplatin, a randomized control study was performed to compare the efficacy of anti-nausea and vomiting between ramosetron and ondansetron. METHODS: A randomized parallel control trial was carried out. One hundred patients were randomized divided into 2 groups: ramosetron group (n=50) and ondansetron group (n=50). Ramosetron was given intravenously 30 minutes before chemotherapy in a dose of 0.3mg. Ondansetron was given intravenously 15 minutes before chemotherapy and after chemotherapy in a dose of 8mg . RESULTS: The effective rate of nausea by ramosetron was 82%, 72% and 84% for the first three days. The effective rate of nausea by ondansetron in a 3-day period was 84%, 70% and 76% for the first three days. Ramosetron and ondansetron were equally effective in the control of nausea induced by cisplatin. The control rate of vomiting by ramosetron was 88%, 86% and 90% for the first three days. The control rate of vomiting by ondansetron was 80%, 76% and 86% for the first three days. Ramosetron was more effective than ondansetron in controlling vomiting, but without statistical difference between the two groups. The side effects of ramosetron and ondansetron were similar. CONCLUSIONS:Ramosetron can effectively prevent the nausea and vomiting induced by cisplatin chemotherapy. The efficacy of ramosetron in controlling nausea and vomiting is better than that of ondansetron.
RCT Entities:
BACKGROUND:Cisplatin has remarkable anti-tumor effects against various malignancies. Of its severe adverse reactions, nausea and vomiting are considered to be dose-limiting factors in cisplatin therapy. The anti-emetic properties of 5-HT₃ receptor antiagonists, such as ramosetron, can reduce nausea/vomiting. In order to evaluate the clinical efficacy of ramosetron injection against nausea and vomiting in treatment of cisplatin, a randomized control study was performed to compare the efficacy of anti-nausea and vomiting between ramosetron and ondansetron. METHODS: A randomized parallel control trial was carried out. One hundred patients were randomized divided into 2 groups: ramosetron group (n=50) and ondansetron group (n=50). Ramosetron was given intravenously 30 minutes before chemotherapy in a dose of 0.3mg. Ondansetron was given intravenously 15 minutes before chemotherapy and after chemotherapy in a dose of 8mg . RESULTS: The effective rate of nausea by ramosetron was 82%, 72% and 84% for the first three days. The effective rate of nausea by ondansetron in a 3-day period was 84%, 70% and 76% for the first three days. Ramosetron and ondansetron were equally effective in the control of nausea induced by cisplatin. The control rate of vomiting by ramosetron was 88%, 86% and 90% for the first three days. The control rate of vomiting by ondansetron was 80%, 76% and 86% for the first three days. Ramosetron was more effective than ondansetron in controlling vomiting, but without statistical difference between the two groups. The side effects of ramosetron and ondansetron were similar. CONCLUSIONS:Ramosetron can effectively prevent the nausea and vomiting induced by cisplatin chemotherapy. The efficacy of ramosetron in controlling nausea and vomiting is better than that of ondansetron.