[天然α干扰素“Sumiferon”简介]

[Introduction of natural interferon-alpha "Sumiferon"].

作者信息

Tsukagoshi S

出版信息

Gan To Kagaku Ryoho. 1987 Sep;14(9):2800-3.

PMID:3631977

Abstract

Natural interferon-alpha preparation "Sumiferon" was recently developed in Japan. This is a human lymphoblastoid interferon (HLBI) preparation. Like other interferon preparations, this preparation showed both direct and indirect antitumor effect and the toxicities were moderate. The phase I-II studies were carried out in 38 major institutions in Japan. In the phase I study in 5 patients with advanced breast cancer, the maximum tolerated dose (MTD) was found to be 12 X 10(6) units/day given for 1 month. In the phase II study, HLBI was given in at 3 approximately 6 X 10(6) units/day. Out of 391 cases, 280 were evaluable. Complete and partial responses (CR and PR) were observed in 40 (14.3%) out of 280 evaluable cases, including 11 (19.6%) out of 56 renal cell cancer, 14 (19.2%) out of 73 multiple myeloma, and 9 (17.3) out of 52 malignant lymphoma among others. Major side effects observed were: fever (69.8%), gastrointestinal disturbances (31.4%), leukopenia (30.7%), thrombocytopenia (27.8%), hepatotoxicities (23.6%) and general fatigue (22.1%). Sumiferon seemed to be one of useful antitumor drugs effective against renal cancer.

摘要

天然干扰素α制剂“Sumiferon”最近在日本研制成功。这是一种人淋巴母细胞干扰素（HLBI）制剂。与其他干扰素制剂一样，该制剂显示出直接和间接的抗肿瘤作用，且毒性适中。在日本的38家主要机构进行了I-II期研究。在针对5例晚期乳腺癌患者的I期研究中，发现最大耐受剂量（MTD）为12×10⁶单位/天，给药1个月。在II期研究中，HLBI的给药剂量约为3×6×10⁶单位/天。在391例病例中，280例可评估。在280例可评估病例中，有40例（14.3%）观察到完全缓解和部分缓解（CR和PR），其中包括56例肾细胞癌中的11例（19.6%）、73例多发性骨髓瘤中的14例（19.2%）以及52例恶性淋巴瘤中的9例（17.3%）等。观察到的主要副作用有：发热（69.8%）、胃肠道紊乱（31.4%）、白细胞减少（30.7%）、血小板减少（27.8%）、肝毒性（23.6%）和全身疲劳（22.1%）。Sumiferon似乎是一种对肾癌有效的有用抗肿瘤药物之一。