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硫酸长春碱5天持续输注的I-II期试验。

Phase I-II trial of a 5-day continuous infusion of vinblastine sulfate.

作者信息

Zeffren J, Yagoda A, Kelsen D, Winn R

出版信息

Anticancer Res. 1984 Nov-Dec;4(6):411-3.

PMID:6517534
Abstract

Vinblastine sulfate was administered to 28 patients as a continuous infusion for five consecutive days in doses of 0.75 to 2.0 mg/m2. Pharmacokinetic studies in 4 patients showed that plasma levels increased rapidly after beginning the infusion with a steady state occurring in 10-48 hours at 2 ng/ml for 1.25 mg/m2, and 5-8 ng/ml for 2.0 mg/m2. The T 1/2 b after completion of the infusion was 19 hours. Dose-limiting toxicity was myelosuppression. A partial remission of four months duration was observed in a patient with adenocarcinoma of the gastroesophageal junction. One patient, who had been heavily pretreated, obtained partial remission while three patients with breast cancer had a minor response. There was no response in 10 patients with hypernephroma. The suggested starting dose is 2 mg/m2 for un-pretreated cases and 1.75 mg/m2 daily for 5 consecutive days monthly for prior treated cases.

摘要

对28例患者给予硫酸长春碱,以0.75至2.0mg/m²的剂量连续输注5天。对4例患者进行的药代动力学研究表明,输注开始后血浆水平迅速升高,对于1.25mg/m²的剂量,在10 - 48小时内达到2ng/ml的稳态,对于2.0mg/m²的剂量,达到5 - 8ng/ml的稳态。输注结束后的T 1/2 b为19小时。剂量限制性毒性为骨髓抑制。在一名胃食管交界腺癌患者中观察到持续四个月的部分缓解。一名接受过大量预处理的患者获得部分缓解,而三名乳腺癌患者有轻微反应。10例肾细胞癌患者无反应。对于未接受过治疗的病例,建议起始剂量为2mg/m²,对于先前接受过治疗的病例,建议每月连续5天每天1.75mg/m²。

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