格宁预防肿瘤化疗所致白细胞减少的随机对比研究

Randomized Controlled Study of Gening (Domestic RecombinantHuman Granulocyte-Macrophage Colony Stimulating Factor, rhGM-CSF)on Leucopenia Induced by Combination Chemotherapy

摘要: 为观察格宁(国产基因重组人粒细胞/巨噬细胞集落刺激因子, rhGM/CSF) 的临床效果和不良反应, 于1996年3月～ 1997年3月组织临床协作组对格宁进行了多中心随机、自身交叉对照的临床研究, 现报告其结果。
- 化学疗法 /
- 白细胞减少症 /
- 粒细胞/巨噬细胞集落刺激因子 /
- 格宁
Abstract: Objective: To evaluate the efficacy and toxicity of domestic rhGM-CSF, Gening in prevention of leucopenia and neutropenia caused by cancer chemotherapy. Methods: A multicenter, randomized, match and cross-over clinical trial, 65 patients were divided into AB and BA groups and two-cycle treatment were given to each patient.In group AB, combination chemotherapy and Gening were given in the first cycle and combination chemotherapy alone was given in the second cycle, while vice versa in group BA. Results: Geningsignificantly increased the number of white blood cell and the absolute neutrophil count at the nadir, shorten the days with leucopenia and neutropenia of chemotherapy patients with the acceptable the adverse reactionseg. mild or moderate fever, injection site reaction, bone pain, myalgia, asthenia and skin rash. Conclusion: Gening is a valuable adjuvant in cancer chemotherapy.
- Chemotherapy /
- Leucopenia /
- rhGM-CSF /
- Gening

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