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

Mian Xie, Hai Ying Wu, Ying Guo, Jun Ling Liu, Zhong-Zhen Guan, Ya Li Liu, Ping Hui Wang, Qiang Chen, Ping Huang, Jian Wei Yang

    Research output: Contribution to journalArticle

    Abstract

    BACKGROUND & OBJECTIVE: Navoban (import tropisetron hydrochloride) can effectively prevent chemotherapy-induced nausea and vomiting; however, it is too expensive to be used extensively in clinic. This study was designed to compare the antiemetic efficacies and side effects of China-made tropisetron hydrochloride with Navoban. METHODS: A multicenter and randomized controlled trial was 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-based chemotherapy. The gastrointestinal reactions induced by chemotherapy and side effects of the antiemetics were recorded within 7 days after chemotherapy. RESULTS: 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 completely in 25.8% of the patients in group A and in 28.1% of group B; delayed vomiting 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 well tolerated, and no difference in adverse events between the 2 groups was observed (P > 0.05). CONCLUSION: China-made tropisetron hydrochloride is as effective as Navoban in the prevention of chemotherapy-induced nausea and vomiting, and only causes mild, infrequent side effects.

    Original languageEnglish (US)
    Pages (from-to)998-1001
    Number of pages4
    JournalAi zheng = Aizheng = Chinese journal of cancer
    Volume24
    Issue number8
    StatePublished - Jan 1 2005

    ASJC Scopus subject areas

    • Oncology

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  • Cite this

    Xie, M., Wu, H. Y., Guo, Y., Liu, J. L., Guan, Z-Z., Liu, Y. L., Wang, P. H., Chen, Q., Huang, P., & Yang, J. W. (2005). Preventive efficacies of china-made tropisetron hydrochloride and Navoban on chemotherapy-induced nausea and vomiting: a randomized controlled clinical trial. Ai zheng = Aizheng = Chinese journal of cancer, 24(8), 998-1001.