托烷司琼预防化疗期间恶心和呕吐的多中心临床研究

[Tropisetron for the prevention of nausea and vomiting during chemotherapy: multicenter clinical study].

作者信息

Gutiérrez J, Bronfman L, Cao C, Vásquez A, Derio L, Rosas J, del Castillo C, Yáñez M, Fodor M, Gallardo J, Cerda B, Torres R, Orlandi L, Orlandi F, Kleinman S, Vogel C

机构信息

Hospital San Juan de Dios, Hospital Clínico de la Universidad de Chile, Santiago de Chile.

出版信息

Rev Med Chil. 1996 Aug;124(8):967-74.

PMID:9196997

Abstract

The antiemetic effect of tropisetron was studied in 97 cancer patients (67 men, 30 women) receiving cisplatin in doses of 75 mg/m2 or higher. On 279 chemotherapy cycles studied (max 6 per patient) 5 mg of tropisetron was administered once a day i.v on day 1 and p.o. on days 2 to 6. Efficacy preventing vomiting and nausea was measured in 24 hour period as: complete control O episodes, major control 1 to 2 episodes, minor control 3 to 4 episodes and no control 5 or more episodes. Satisfactory vomiting control (complete and major) was 69%, 63%, 82%, 88%, 96% and 96% in days 1 to 6 of cycle 1. Satisfactory nausea control (complete and major) for the same days was 70%, 66%, 72%, 85%, 92% and 97%. Similar data was obtained for the subsequent cycles. Complete vomiting control was obtained in 47%, 35%, 56%, 72%, 81% and 84% and for nausea in 42%, 39%, 48%, 64%, 81% and 87%. 19 patients presented adverse effects (19.6%). Only 2 headache episodes had a definite relation with the antiemetic drug. 12 patients discontinued the medication; 6 due to drug inefficacy, 2 to illness unrelated to the drug, 1 to lack of collaboration, and 3 due to other reasons. We conclude that tropisetron allows satisfactory control of acute and delayed vomiting in a high percentage of patients treated with high doses of cisplatin. The drug does not have significant secondary effects. Tropisetron administration in only one daily dose implies an evident advantage and a treatment cost reduction.

摘要

在97例接受剂量为75mg/m²或更高顺铂治疗的癌症患者（67名男性，30名女性）中研究了托烷司琼的止吐效果。在所研究的279个化疗周期（每位患者最多6个周期）中，在第1天静脉注射5mg托烷司琼，每天1次，并在第2至6天口服。在24小时内测量预防呕吐和恶心的疗效，分为：完全控制0次发作、主要控制1至2次发作、次要控制3至4次发作和未控制5次或更多次发作。在第1周期的第1至6天，满意的呕吐控制（完全和主要控制）率分别为69%、63%、82%、88%、96%和96%。在相同天数内，满意的恶心控制（完全和主要控制）率分别为70%、66%、72%、85%、92%和97%。后续周期获得了类似的数据。完全呕吐控制率分别为47%、35%、56%、72%、81%和84%，恶心完全控制率分别为42%、39%、48%、64%、81%和87%。19例患者出现不良反应（19.6%）。只有2例头痛发作与止吐药物有明确关系。12例患者停药；6例因药物无效，2例因与药物无关的疾病，1例因缺乏合作，3例因其他原因。我们得出结论，托烷司琼能使高剂量顺铂治疗的患者中很大比例的急性和迟发性呕吐得到满意控制。该药物没有明显的副作用。每天仅服用一次托烷司琼具有明显优势并降低了治疗成本。