Objective: To further evaluate the clinical usefulness of ondensetron(OND, supplied by Qilu Pharmaceutical Company) with modified regime in the prevention of cisplatin (DDP)-induced nausea and vomiting.
Methods: A total of 773 patients were enrolled in a multicenter cooperative study. Of them, 330 patients were given i.v. OND 8 mg once or twice a day and 443 patients were given i.v. OND 8 mg plus dexamethasone(DXM) 10 mg once a day during the therapeutic period of DDP, followed by OND 4 mg orally twice a day for two days after DDP treatment.
Results: Effective control of acute nausea was achieved in 86.7% and 94.8% of the patients receiving OND alone and OND plus DXM, respectively(P < 0.001). The mean frequency of vomiting was 0.9 times in OND and 0.4 times in OND plus DXM(P < 0.01). Total control of delayed vomiting (day 2-5) was comparable in both groups. Complete inhibition of vomiting (CR rate) was more frequently observed in males than in females. Adverse effects were identical and well tolerated.
Conclusion: OND with modified regimen is effective in the control of DDP-induced vomiting. It is more effective when OND and DXM are given than OND given alone.