摘要
目的研究基因重组人粒细胞／巨噬细胞集落刺激因子（ｒｈＧＭ－ＣＳＦ，生白能）防治实体瘤化疗所致白细胞（ＷＢＣ）和中性粒细胞（ＡＮＣ）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，对５７例肿瘤化疗患者随机分成ＡＢ组和ＢＡ组。ＡＢ组第１周期化疗加生白能治疗（治疗组），第２周期单用化疗（对照组）；ＢＡ组第１周期单用化疗，第２周期化疗加生白能治疗。有５５例可做临床疗效分析。结果生白能可明显减轻化疗所致ＷＢＣ和ＡＮＣ下降程度，缩短ＷＢＣ和ＡＮＣ降至正常值以下的持续时间，促进ＷＢＣ和ＡＮＣ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，骨骼肌肉疼痛，乏力和皮疹，一般可以耐受。结论生白能是一种有价值的化疗辅助药物。
Objective To evaluate leucomax (rhGM CSF) in prevention and treatment of leucopenia and neutropenia induced by chemotherapy in cancer patients. Methods A multicenter, randomized, matched and cross over clinical trial of the effect of leucomax on leucopenia and neutropenia induced by combination chemotherapy in cancer patients was conducted. Fifty seven enrolled patients were randomized into AB group and BA group. Each patient received two cycles of treatment. In group AB, combination chemotherapy and leucomax were used in the first cycle and combination chemotherapy alone was used in the second cycle, while vice versa in group BA. In 2 patients, the study was stopped due to leucomax adverse reactions. Fifty five patients were eligible for analysis of clinical efficacy. Results Leucomax significantly increased the number of total white blood cell count and absolute neutrophil count at the nadir, decreased the incidence of leucopenia and neutropenia and shortened the time period of leucopenia and neutropenia induced by chemotherapy. Leucomax also resulted in quicker recovery of leucopenia and neutropenia. Leucomax ensured the scheduled chemotherapy. The main adverse reactions with mild to moderate fever, pain at the injection site, bone pain, myalgia, asthenia and skin rash were generally tolerable. Conclusion Leucomax is a valuable adjunct in cancer chemotherapy.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
1998年第6期451-453,共3页
Chinese Journal of Oncology
关键词
肿瘤
药物疗法
白细胞减少
治疗
RHGM-CSF
Neoplasms/drug therapy
Leucopenia/therapy
Neutropenia/therapy Granulocyte ma crophage colony stimulating factor
Leucomax
