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利百多预防肿瘤化疗所致白细胞减少的随机对比Ⅱ期临床研究 被引量:8

A Randomized and Controlled Study of Libaiduo on Leucopenia Induced by Combination Chemotherapy on Cancer Patients
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摘要 目的: 为观察利百多( 国产基因重组人粒细胞/ 巨噬细胞集落刺激因子,rhGM- CSF) 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68 例肿瘤化疗患者随机分成AB 组和BA 组。AB 组第一周期化疗加利百多治疗( 治疗组) , 第二周期单用化疗( 对照组) ;BA 组则第一周期单用化疗,第二周期化疗加利百多治疗。60 例可供临床疗效分析。结果:利百多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 的早日恢复,有助于化疗按期进行。结论:利百多对化疗所致白细胞减少有明显预防作用。主要不良反应有轻中度发热,注射部位疼痛,乏力。少数有寒战、流涕和皮疹,一般可以耐受。 Objective: To evaluate the efficacy of Libaiduo (the domestic rhGM-CSF) in prevention of neutropenia caused by chemotherapy of cancer patients. Methods:A multicenter, randomized, match and cross-over clinical trial employing Libaiduo on leucopenia and neutropenia caused by combination chemotherapy on cancer patients was conducted. Sixty-eight enrolled patients were randomized into AB and BA group. Each patient received two cycles of chemotherapy. For patients in group AB, combination chemotherapy and Libaiduo were used in the first cycle and combination chemotherapy alone was used in the first cycle and combination chemotherapy plus Libaiduo were used in the second cycle. Eight patients were dropped off due to Libaiduo side effects. Sixty patients were evaluable for clinical efficacy. Results: The results showed that Libaiduo significantly increased the number of white blood cell (WBC) and the absolute neutrophil count (ANC) at the stage of nadir. Incidence of leucopenia and neutropenia was reduced and the days with WBC< 4.0×109/L or ANC< 2.0×109/L were shortened. Libaiduo also resulted in hastening recovery from leucopenia and neutropenia. Conclusion: The administration of Libaiduo ensures the implement of scheduled chemotherapy. The main side effects such as mild or moderate fever, osteomyalgia, asthenia and skin rash were generally tolerable.
出处 《中国肿瘤临床》 CAS CSCD 北大核心 1999年第11期843-846,共4页 Chinese Journal of Clinical Oncology
关键词 化学治疗 白细胞减少症 利百多 RHGM-CSF Chemotherapy Leukopenia rhGM-CSF Libaiduo
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