比较托烷司琼单独使用及与地塞米松联合使用预防顺铂所致急性和迟发性呕吐的随机双盲研究。

Randomised double-blind study comparing tropisetron alone and in combination with dexamethasone in the prevention of acute and delayed cisplatin-induced emesis.

作者信息

Garcia-del-Muro X, Vadell C, Pérez Manga G, Bover I, Rifá J, Beltrán M, Barros M M, Germá J R, Fabregat X, Moreno V, Salvador A, Viladiu P

机构信息

Institut Català d'Oncologia, Hospital Duran i Reynals, Dept. of Medical Oncology, Barcelona, Spain.

出版信息

Eur J Cancer. 1998 Jan;34(1):193-5. doi: 10.1016/s0959-8049(97)00367-5.

DOI:10.1016/s0959-8049(97)00367-5

PMID:9624257

Abstract

In a randomised, double-blind and parallel-design multicentre study, 282 chemotherapy-naive cancer patients received tropisetron 5 mg intravenously (i.v.) before high-dose cisplatin on day 1, and oral tropisetron 5 mg daily on days 2-6, in combination with either placebo (n = 143) or dexamethasone (n = 135), given i.v. on day 1 and orally on days 2-6. Complete protection from acute vomiting/nausea was achieved in 76.3%/79.3% of patients receiving the combination and in 55.2%/61.5% of those receiving tropisetron alone. Complete protection on days 2-6 from delayed vomiting/nausea was obtained in 60%/60% and 39.2%/40.6%, respectively. Tropisetron in combination with dexamethasone is safe and more effective than tropisetron alone in the prevention of both acute and delayed cisplatin-induced emesis.

摘要

在一项随机、双盲、平行设计的多中心研究中，282例初治癌症患者在第1天接受高剂量顺铂治疗前静脉注射5毫克托烷司琼，在第2 - 6天每天口服5毫克托烷司琼，并分别联合安慰剂（n = 143）或地塞米松（n = 135），地塞米松在第1天静脉注射，在第2 - 6天口服。接受联合用药的患者中，76.3%/79.3%的患者完全预防了急性呕吐/恶心，而单独接受托烷司琼治疗的患者中这一比例为55.2%/61.5%。在第2 - 6天，联合用药组和单独使用托烷司琼组分别有60%/60%和39.2%/40.6%的患者完全预防了延迟性呕吐/恶心。托烷司琼联合地塞米松在预防顺铂引起的急性和延迟性呕吐方面比单独使用托烷司琼更安全、更有效。