Smith R N
Glaxo Group Research Limited, Greenford, Middlesex, U.K.
Eur J Cancer Clin Oncol. 1989;25 Suppl 1:S47-50; discussion S51-4.
The safety of ondansetron has been reviewed based on experience in its use as an anti-emetic treatment in about 1,400 patients receiving cancer treatment and further experience in about 650 volunteers and patients with other medical conditions. Evidence from animal pharmacology and toxicology had indicated that ondansetron had a wide therapeutic index, no interaction with commonly co-prescribed drugs, and no dependence liability. No end-organ toxicity had been seen. Clinical experience showed that ondansetron is well tolerated; the principal side effects being constipation and headache, which in the context of cancer treatment were not troublesome. Increases in liver function tests were observed, undoubtedly due in many instances to the underlying cancer or metastases and to chemotherapy, and the incidence was similar on ondansetron and metoclopramide. No extrapyramidal side effects were reported.
在约1400名接受癌症治疗的患者中作为止吐治疗的使用经验，以及在约650名志愿者和患有其他疾病的患者中的进一步经验。动物药理学和毒理学证据表明，昂丹司琼具有广泛的治疗指数，与常用的联合处方药无相互作用，且无成瘾性。未观察到终末器官毒性。临床经验表明，昂丹司琼耐受性良好；主要副作用为便秘和头痛，在癌症治疗背景下并不麻烦。观察到肝功能检查结果升高，无疑在许多情况下是由于潜在的癌症或转移以及化疗所致，且昂丹司琼和甲氧氯普胺的发生率相似。未报告锥体外系副作用。
