Nasea ~ injection in the prophylaxis of gastrointestinal reaction induced by chemotherapeutic agents

2000 
OBJECTIVE: To evaluate the efficacy and side effects of nasea injection for the prophylaxis of gastrointestinal reactions induced by chemotherapeutic agents, and compare them with those of kytril. METHODS: A multicenter, open, randomized self-crossover control trial was carried out. All the eligible patients were randomized into AB or BA group. The patients in AB group were treated by nasea in the first cycle and kytril in the second cycle, those in BA group were treated with the drugs in the reverse order. RESULTS: In patients enrolled in this study, 98 patients were evaluable for response, including 61 patients in DDP-arm and 37 in ADM-arm. Nasea was as effective as kytril in the control of anorexia, nausea and vomiting in the 0-6 hour period after chemotherapy. Nasea was significantly superior to kytril in the complete control of anorexia (38.8% vs 25.5%, P < 0.05) in the 0-24 hour period. The overall control rate of nausea by nasea in the 0-12, 0-18, and 0-24 hour period was 73.6%, 71.4%, 67.3%, respectively, which was significantly higher than that by kytril (65.3%, 61.2%, 48%). Nevertheless, in the control of vomiting in the 0-24 hour period, no statistical difference between the two drugs was observed. Nasea and kytril were equally effective in the control of anorexia, nausea and vomiting induced by DDP and ADM. The side effects of nasea were head heaviness, headache, dry mouth and constipation, etc. All of these were mild and comparable with kytril in their frequencies. CONCLUSION: Nasea can effectively prevent the gastrointestinal reaction induced by chemotherapeutic agents. The side effects of nasea are similar to those of kytril but its effect to alleviate gastrointestinal reactions is of longer duration.
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