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重组人γ干扰素与长春碱Ⅰ期试验期间的低钠血症及其他毒性作用。

Hyponatremia and other toxic effects during a phase I trial of recombinant human gamma interferon and vinblastine.

作者信息

Bennett C L, Vogelzang N J, Ratain M J, Reich S D

出版信息

Cancer Treat Rep. 1986 Sep;70(9):1081-4.

PMID:3091246
Abstract

Recombinant human gamma interferon (Biogen) and vinblastine were administered in a phase I study. Side effects included fever and chills, nausea and vomiting, acute symptomatic hyponatremia, reversible myelosuppression, hepatitis, transient hypotension, congestive heart failure, renal insufficiency, and nonselective proteinuria. In most patients, additional host factors contributed to these toxic effects. Side effects occurred despite dose reduction; therefore, protocol accrual was prematurely closed. No correlation between serum concentrations and toxicity was noted. Median serum vinblastine concentration was 1.04 ng/ml; median serum interferon concentration was 17.3 IU/ml.

摘要

在一项I期研究中使用了重组人γ干扰素(生物基因公司生产)和长春碱。副作用包括发热、寒战、恶心和呕吐、急性症状性低钠血症、可逆性骨髓抑制、肝炎、短暂性低血压、充血性心力衰竭、肾功能不全和非选择性蛋白尿。在大多数患者中,其他宿主因素也导致了这些毒性作用。尽管降低了剂量,但副作用仍有发生;因此,该试验方案的入组提前结束。未观察到血清浓度与毒性之间的相关性。长春碱血清浓度中位数为1.04 ng/ml;干扰素血清浓度中位数为17.3 IU/ml。

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