Preventive efficacies of china-made tropisetron hydrochloride and Navoban on chemotherapy-induced nausea and vomiting: a randomized controlled clinical trial

BACKGROUND OBJECTIVE: Navoban (import tropisetron hydrochloride) ca n effectively prevent chemotherapy-induced nausea and vomiting; however, it is t oo expensive to be used extensively in clinic. This study was designed to compar e the antiemetic efficacies and side effects of China-made tropisetron hydroc hloride with Navoban. METHODS: A multicenter and randomized controlled trial w as carried out. A total of 132 cancer patients were randomized into 2 groups and received 5 mg of China-made tropisetron hydrochloride (group A, 66 patients) or Navoban (group B, 66 patients) intravenously before cisplatin- or adriamycin-ba sed chemotherapy. The gastrointestinal reactions induced by chemotherapy and sid e effects of the antiemetics were recorded within 7 days after chemotherapy. RES ULTS: Acute nausea was prevented completely in 48.5% of the patients in group A and in 43.8% of group B; acute vomiting was prevented completely in 69.7% of the patients in group A and in 67.2% of group B. Delayed nausea was prevented compl etely in 25.8% of the patients in group A and in 28.1% of group B; delayed vomit ing was prevented completely in 47.0% of the patients in group A and in 51.6% of group B. No significant differences in complete control of nausea and vomiting showed between group A and group B (P 0.05). Both antiemetic regimens were wel l tolerated, and no difference in adverse events between the 2 groups was observ ed (P 0.05). CONCLUSION: China-made tropisetron hydrochloride is as effective as Navoban in the prevention of chemotherapy-induced nausea and vomiting, and on ly causes mild, infrequent side effects.