Effects of recombinant human interleukin-6 in cancer patients: a phase I-II study.
Effects of recombinant human interleukin-6 in cancer patients: a phase I-II study.
复制标题
重组人白细胞介素 6 对癌症患者的影响：一项 I-II 期研究。
作者：
M. M. V. Gameren;P. Willemse;N. Mulder;P. Limburg;H. Groen;E. Vellenga;E. D. Vries
为了确定重组人白细胞介素 6 (rhIL-6) 的毒性特征并研究其对造血、生化参数和其他细胞因子的影响，在一项 I-II 期研究中，对 20 名乳腺癌或非小细胞肺癌患者施用了 rhIL-6。 RhIL-6 剂量为 0.5、1.0、2.5、5.0、10 和 20 微克/公斤/天，每个剂量水平至少有 3 名患者。 RhIL-6 通过连续静脉输注 24 小时给药，然后皮下 (SC) 给药 6 天，部分在门诊进行。 RhIL-6 相关副作用包括发烧、头痛、肌痛和局部红斑。从 2.5 微克/公斤/天开始，这些副作用因恶心、肝酶可逆性增加和贫血而加剧。流感样症状在高达 10 微克 rhIL-6/kg/d 和对乙酰氨基酚的情况下是可以控制的。 rhIL-6 增加血小板计数，平均血小板体积减少，中性粒细胞、单核细胞和淋巴细胞增加导致白细胞增加，T 细胞和自然杀伤细胞在 1.0 和 2.5 微克 rhIL-6/kg/d 时增加。可逆性贫血的特征是血清铁减少，铁蛋白和促红细胞生成素增加，但无网织红细胞增多。 RhIL-6 降低了总胆固醇水平，并且观察到 C 反应蛋白和血清淀粉样蛋白 A 血浆水平与剂量相关。血清 IL-6 水平升高，尤其是在 10 和 20 微克/公斤/天时，而 IL-1 β 和肿瘤坏死因子 α 水平没有变化。在这种情况下，RhIL-6 的副作用是可控的，门诊皮下注射剂量高达 10 微克/公斤/天，并且对白细胞生成和血小板生成具有良好的刺激作用。
To define the toxicity profile of recombinant human interleukin-6 (rhIL-6) and to study its effect on hematopoiesis, biochemical parameters and other cytokines, rhIL-6 was administered in a phase I-II study to 20 patients with breast carcinoma or nonsmall cell lung cancer. RhIL-6 doses were 0.5, 1.0, 2.5, 5.0, 10, and 20 micrograms/kg/d, with at least three patients per dose level. RhIL-6 was administered 24 hours by continuous intravenous infusion followed by subcutaneous (SC) administration for 6 days, partly on an outpatient basis. RhIL-6-related side effects were fever, headache, myalgia, and local erythema. Starting at 2.5 micrograms/kg/d, these side effects were compounded by nausea, reversible increase in liver enzymes, and anemia. Flu-like symptoms were controllable up to and including 10 micrograms rhIL-6/kg/d with acetaminophen. RhIL-6 increased platelet counts with a decrease in mean platelet volume and increased leukocytes caused by neutrophil, monocyte, and lymphocyte increase, with an increase in T cells and natural killer cells at 1.0 and 2.5 micrograms rhIL-6/kg/d. The reversible anemia was characterized by a decrease in serum iron, and an increase in ferritin and erythropoietin without reticulocytosis. RhIL-6 reduced total cholesterol levels and a dose-related increase of C-reactive protein and serum amyloid A plasma levels was observed. Serum IL-6 levels were increased, especially at 10 and 20 micrograms/kg/d, whereas no change in IL-1 beta and tumor necrosis factor alpha levels was observed. RhIL-6 can be administered with controllable side effects in this setting, up to and including a SC dose of 10 micrograms/kg/d on an outpatient basis, and has a promising stimulating effect on leukopoiesis and thrombopoiesis.
影响因子：
20.3
作者：
R. Means;Sanford E. Krantz
通讯作者：
R. Means;Sanford E. Krantz
DOI：
10.1200/jco.1992.10.7.1141
发表时间：
1992-07
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
J. Smith;W. Urba;B D Curti;L J Elwood;R. Steis;J. E. Janik;W. Sharfman;L L Miller-L;R G Fenton;K C Conlon
通讯作者：
J. Smith;W. Urba;B D Curti;L J Elwood;R. Steis;J. E. Janik;W. Sharfman;L L Miller-L;R G Fenton;K C Conlon