一项针对恶性胸腔积液患者的胸膜内注射重组人干扰素α（rHuIFNα2b）的I期试验。
A phase I trial of intrapleural recombinant human interferon alpha (rHuIFN alpha 2b) in patients with malignant pleural effusions.
作者信息
Bhatia A, Rice T W, McLain D, Herzog P, Budd G T, Murthy S, Kirby T J, Bukowski R M
机构信息
Department of Hematology and Medical Oncology, Cleveland Clinic Foundation, Ohio 44195.
出版信息
J Cancer Res Clin Oncol. 1994;120(3):169-72. doi: 10.1007/BF01202197.
The use of intrapleural sclerosing agents to control reaccumulation of pleural fluid in patients with malignant effusions has been widely investigated. A phase I trial of intrapleural recombinant human interferon alpha (rHuIFN alpha 2b) was initiated to determine the toxicity and maximal tolerated dose in this group of patients. rHuIFN alpha 2b was instilled as a single dose following chest tube (15/16) or percutaneous (1/16) drainage of cytologically proven malignant effusions. Doses of rHuIFN alpha 2b were escalated from 25 x 10(6) to 200 x 10(6) U/m2 in cohorts of three to four patients. Toxicity was mild to moderate, and included chills, fever and chest pain, and resembled that produced by systemic administration of rHuIFN alpha 2b. Dose-limiting toxicity occurred at 200 x 10(6) U/m2 and consisted of hepatic enzyme elevations and renal failure. Partial control of the effusions was noted in two patients, with two additional patients having stable disease. Phase II trials of rHuIFN alpha 2b should utilize up to 150 x 10(6) U/m2 for intrapleural instillation.
胸膜内硬化剂用于控制恶性胸腔积液患者胸腔积液再积聚的情况已得到广泛研究。开展了一项胸膜内重组人干扰素α（rHuIFNα2b）的I期试验，以确定该组患者的毒性和最大耐受剂量。在经细胞学证实的恶性胸腔积液通过胸腔闭式引流管（15/16）或经皮穿刺（1/16）引流后，将rHuIFNα2b作为单剂量注入。rHuIFNα2b的剂量在三到四名患者的队列中从25×10⁶U/m²逐步递增至200×10⁶U/m²。毒性为轻度至中度，包括寒战、发热和胸痛，与全身给予rHuIFNα2b所产生的毒性相似。剂量限制性毒性出现在200×10⁶U/m²时，表现为肝酶升高和肾衰竭。两名患者的胸腔积液得到部分控制，另有两名患者病情稳定。rHuIFNα2b的II期试验胸膜内注入剂量应采用高达150×10⁶U/m²。
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