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Thursday 01 April 2004

[Tropisetron in attenuation of nausea and vomiting in patients undergoing high-dose chemo-radiotherapy supported by autologous peripheral blood stem cell transplantation]

By: He XH, Shi YK, Yang JL, Zhang CG, Liu P, Zhou AP, Zhou SY, Ai B.

Ai Zheng 2004 Apr;23(4):456-60

BACKGROUND & OBJECTIVE: High-dose conditioning regimens of chemo-radiotherapy with or without total body irradiation (TBI) frequently induces nausea and vomiting in patients who are supported with stem cell transplantation. 5-Hydroxytrypamine(3) (5-HT(3)) receptor antagonists, when used alone, are unsatisfactory in the attenuation of emesis; Furthermore, consensus about their optimal dose, optimal dosing frequency and the combined use with other anti-emetic drugs are still controversial. The main objective of this trial was to observe the anti-emetic effectiveness and side effects of tropisetron plus dexamethasone and diphenhydramine (Group A) and tropisetron alone (Group B) on the patients undergoing high-dose treatment for peripheral blood stem cell (PBSC) mobilization and transplantation. METHODS: From December 1998 to September 2002, 68 patients undergoing autologous peripheral blood stem cell transplantation were allotted into this study. All the eligible patients were divided into group A or B non-randomly to compare the efficacy of the two regimens in the prevention of nausea and vomiting induced by high-dose treatment. Regimens:40 patients in group A were given tropisetron 5 mg,iv,every 12 h plus dexamethasone 5-10 mg, iv, daily, and diphenhydramine, 20 mg, im, daily. Twenty-eight patients in group B were received tropisetron alone,5 mg,iv,every 12h. RESULTS: For nausea during the acute phase, complete response rates of group A and B were 55% and 46.4%, with an overall response rates of 97.5% and 85.7%,of which the difference was insignificant (P >0.05). For vomiting during the acute phase, complete response rates of group A and B were 77.5% and 78.6%, with an overall response rates of 90% and 92.9%, of which the difference was insignificant (P >0.05). For delayed phase, both the complete response and overall response rates were higher in group A, with the difference significant (P< 0.05). The side effects of both regimens were mild. Common side effects including abdomen discomfort,headache,heavy head and constipation did not necessitate the discontinuity of high-dose treatment. CONCLUSION: The combination of tropisetron with dexamethasone and diphenhydramine is more effective than tropisetron alone in the control of nausea and vomiting induced by high-dose chemotherapy with or without TBI, which is especially more effective in the delayed phase of nausea and vomiting. The side effects of the combination regimen were mild. Based on these findings, we stress the importance of large randomized trials in the future.

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