Objective: To evaluate the efficacy and safety of nausea oral, disintegrating buccal tablet (DBT) in the prevention of gastrointestinal reaction induced by anticancer drugs (cisplatin DDP 30 - 50 mg/m(2) or adramycin ADM >/= 40 mg/m(2)), as compared with those of kytril tablets.
Methods: A multicenter, open and randomized self-crossover control trial was carried out with all the eligible patients randomized into AB or BA group. Patients in AB group were given nausea 0.1 mg as buccal tablet one hour before chemotherapy in the first cycle and kytril tablet 2 mg in the second cycle, those in BA group were given these drugs in the reverse order.
Results: Seventy-three patients were allotted to this study, including 44 patients in DDP-arm and 29 in ADM-arm. Sixty-two patients were evaluable for response and 70 patients for safety. Nausea DBT was as effective as kytril tablet in the control of anorexia, nausea and vomiting during the first 24 hours after chemotherapy, with response rates of 74.2%, 77.4%, 83.9% in nausea DBT and 74.2%, 71.0%, 88.7% DBT in kytril tablets. A high efficacy in the control of vommitting induced by cisplatin was observed in both nausea DBT and kytril tablets. The complete control rates and overall control rates were 83.3%, 91.7% in nausea DBT and 86.1%, 97.2% in kytril tablets, respectively. The side effects of nausea DBT were head heaviness, dry mouth and somnolence, which were mild and comparable with kytril in their frequencies.
Conclusion: Nausea disintegrating buccal tablet is able to effectively prevent gastrointestinal reaction induced by anticancer drugs, with efficacy and side effects similar to kytril tablets. Nausea DB tablet, an intraoral disintegrator, is very convenient for patients who can not swallow tablets for various reasons.