A Clinical Research Of The Efficacy And Safety Of Palonosetron In Preventing Chemotherapy-Induced Nausea And Vomiting

ObjectiveTo evaluate the efficacy and safety of Palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV),and give evidence to the clinical application.MethodsA randomized, double-blind double-dummy and self-crossover controlled design was taken. According to the requirement of research-center, 32 qualified cases were chose, including 16 cases in highly emetogenic chemotherapy group (No.49~No.64) and 16 cases in moderately emetogenic chemotherapy group (No.101~No.116). In every two sequential periods of chemotherapy, each patient would be gave Palonosetron (0.25mg: 5ml) by intravenous injection or Granisetron (3mg: 50ml) by intravenous drip 30 minutes before using chemotherapy drugs to prevent the happening of gastrointestinal reactions. Then, the occurrence of inappetence, nausea, vomiting and other gastrointestinal reactions would be observed, as well as the safety indexes, such as vital signs, blood and urine routine, liver and renal function, electrocardiogram, reverse events.Results1 case fell out for each group and actually 30 cases were finished in the end. In highly emetogenic chemotherapy group, Palonosetron's efficacy to nausea was better than Granisetron in 18~24hr of the 1st chemotherapeutic day, and vomiting in 6~12hr and 18~24hr of the 1st chemotherapeutic day (P<0.05). Moreover, efficacy to vomiting of the 2nd chemotherapeutic day is 100% for Palonosetron rather than 86.67% for Granisetron. In moderately emetogenic chemotherapy group, Palonosetron's efficacy to nausea was better than Granisetron in 6~12hr , 12~18hr and 18~24hr of the 1st chemotherapeutic day. The safety indexes between Palonosetron and Granisetron were similar (P>0.05) and made no clinical significance, although some individual differences in the laboratory results. The adverse events during the research were mainly dizzy, dry mouth, asthenia and made no differences between these two drugs (P>0.05). No serious adverse event occurred during the research.ConclusionsPalonosetron plays an efficacious role in preventing chemotherapy-induced nausea and vomiting and has a good safety as well.