重组人粒细胞巨噬细胞集落刺激因子预防白细胞减少的II期临床试验  

Recombinant human granulocyte ma_crophage colony_stimulating factor on leucopenia patients phase II clinical trials

作　　者：周立强[1] 周思源[1] 冯奉仪[1] 

机构地区：[1]中国医学科学院肿瘤医院,北京100021

出　　处：《中国新药与临床杂志》1999年第4期195-198,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的：为研究国产重组人粒细胞巨噬细胞集落刺激因子（ｒｈ Ｇ Ｍ＿ Ｃ Ｓ Ｆ， 商品名里亚尔） 防治实体瘤化疗所致白细胞（ Ｗ Ｂ Ｃ） 和绝对中性粒细胞计数（ Ａ Ｎ Ｃ） 减少的临床效果及不良反应。方法：采用多中心随机分组、自身交叉对照方法，进行了临床 Ｉ Ｉ期试验。６０ 例肿瘤化疗病人随机均分 Ａ Ｂ 组和 Ｂ Ａ组。 Ａ Ｂ 组第１ 周期化疗加ｒｈ Ｇ Ｍ＿ Ｃ Ｓ Ｆ 治疗（ 治疗组） ，第２ 周期单用化疗（ 对照组） ； Ｂ Ａ 组第１ 周期单用化疗，第２ 周期化疗加ｒｈ Ｇ Ｍ＿ Ｃ Ｓ Ｆ 治疗。５６ 例可供临床疗效分析。结果：ｒｈ Ｇ Ｍ＿ Ｃ Ｓ Ｆ 可减轻化疗所致 Ｗ Ｂ Ｃ 和 Ａ Ｎ Ｃ 下降程度，缩短 Ｗ Ｂ Ｃ 和 Ａ Ｎ Ｃ 降至正常值以下的持续时间，促进 Ｗ Ｂ Ｃ 和 Ａ Ｎ Ｃ 减少的早日恢复，有助于化疗按期进行。主要不良反应有轻、中度发热，注射部位疼痛，骨、肌肉疼痛，乏力。少见的有皮疹、寒战、流涕、胸闷、心悸，一般可以耐受。结论：ｒｈ Ｇ Ｍ＿ Ｃ Ｓ Ｆ 是有价值的化疗辅助药物。AIM: To evaluate recombinant human granulocyte macrophage colony_stimulating factors (domestic rhGM_CSF) in prevention of neutropenia induced by cancer chemotherapy. METHODS: A multicenter, randomized, match and cross_over clinical trial of rhGM_CSF on leucopenia and neutropenia induced by combination chemotherapy on cancer patients was conducted. Sixty enrolled patients were randomized into AB and BA group. Each patients received two cycle treatment. In group AB, combination chemotherapy and rhGM_CSF were used in the first cycle and combination chemotherapy alone was used in the second cycle, while in group BA, combination chemotherapy alone was used in the first cycle and combination chemotherapy and rhGM_CSF were used in the second cycle. Four patients study were stopped for rhGM_CSF adverse reactions in 3 patients or disease progression in 1 patient, 56 patients were eligible for analysis of clinical efficacy. RESULTS: rhGM_CSF significantly increased the number of white blood cell (WBC) and absolute neutrophil count (ANC) at the nadir, decreased incidence of leucopenia and neutropenia and shorten the days with leucopenia and neutropenia induced by chemotherapy, rhGM_CSF also resulted in accelerating recovery of leucopenia and neutropenia on chemotherapy patients. The administration of rhGM_CSF ensures the cancer patients' chemotherapy in progress on schedule. The main adverse reactions with mild or moderate fever, injection side reaction, bone pain, myalgia, asthenia and skin rash were generally acceptable. CONCLUSION: The rhGM_CSF is a good adjuvant chemotherapy for cancer.

关 键 词：白细胞减少症 zhGM-CSF 预防 

分 类 号：R557.105[医药卫生—血液循环系统疾病]