Tropisetron (ICS 205-930) in pediatric oncology: first results in patients refractory to antiemetic metoclopramide-based treatments.

G Cefalo, L Rottoli, A Armiraglio, M G Pagan
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Abstract

Purpose: We evaluated the antiemetic efficacy of tropisetron, a 5-HT3 receptor antagonist, during its compassionate use in children with malignant disease who during previous chemotherapy cycles experienced emesis refractory to metoclopramide-based treatments.

Patients and methods: Tropisetron was given to 15 children (eight boys and seven girls 18 months to 18 years of age) with miscellaneous neoplasms. Generally 5 mg/day of tropisetron was administered i.v. the first day of cisplatin-based chemotherapy and i.v. or orally each subsequent day of chemotherapy. The dose of tropisetron was reduced to 2 mg/day in children < 2 years of age and weighing < 20 kg.

Results: Vomiting was well controlled (no more than two episodes per day) on 118 of the 184 days of treatment with tropisetron (64%). No clinically important variations were observed in blood pressure, heart rate, body temperature, or electrocardiographic findings attributable to tropisetron. Transient, mild to moderate side effects (headache, constipation, abdominal pain, diarrhea) occurred in five patients on 11 of the 184 days of tropisetron treatment (6%).

Conclusion: The results obtained during compassionate use of tropisetron confirm that it is a valid, safe, and manageable antiemetic for the treatment of pediatric patients.

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托哌司琼(ICS 205-930)在儿科肿瘤学中的应用:首次用于对止吐胃氯普胺治疗难治性患者。
目的:我们评估了托烷司琼(一种5-HT3受体拮抗剂)在既往化疗周期中出现呕吐难治的恶性疾病儿童中的止吐效果。患者和方法:对15例杂性肿瘤患儿(男8例,女7例,18个月~ 18岁)给予托哌司琼治疗。一般情况下,顺铂类化疗第一天静脉给药5mg /天,化疗后每一天静脉或口服。< 2岁和体重< 20kg的儿童托哌司琼的剂量降至2mg /天。结果:使用托司司琼治疗的184天中,有118天(64%)呕吐控制良好(每天不超过2次)。没有观察到临床上重要的血压、心率、体温或心电图变化可归因于托哌司琼。在曲司司琼184天的治疗中,有11天(6%)有5例患者出现了短暂的、轻至中度的副作用(头痛、便秘、腹痛、腹泻)。结论:体恤使用托哌司琼的结果证实,托哌司琼是一种有效、安全、可控的止吐药。
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