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重组人粒细胞巨噬细胞集落刺激因子(rhGMCSF)是通过基因工程方法产生的药物,因其治疗白细胞减少的有效性和安全性而得以广泛使用。因进口药物价格昂贵,临床应用受到了限制。1995年12月至1996年1月对9例住院病人进行了国产rhGMCSF的Ⅰ期临床试验。每3例为一组,各组分别按2.5,5.0和7.5μg/(kg·d)皮下注射,每例用药7d,共注射63人次,观察到的6种不良反应(疲乏,骨痛,局部疼痛,肌肉酸痛,发热和心悸)均为Ⅰ~Ⅱ级。9例病人全部按计划完成试验,3个剂量组均有较好的耐受。同时,3个剂量组不同程度地显示了升高白细胞的作用
Recombinant human granulocyte macrophage colony-stimulating factor (rhGMCSF) is a genetically engineered drug that has been widely used because of its effectiveness and safety in treating leukopenia. Due to expensive imported drugs, clinical application has been limited. From December 1995 to January 1996, 9 inpatients were enrolled in the phase I clinical trial of rhGMCSF. Each group was divided into three groups. Each group was subcutaneously injected with 2.5, 5.0 and 7.5 μg / (kg · d) respectively. Each group received 63 doses for 7 days. Six adverse reactions (fatigue , Bone pain, local pain, muscle soreness, fever and heart palpitations) were grade Ⅰ ~ Ⅱ. All nine patients completed the trial according to plan, and the three dose groups were well tolerated. At the same time, the three dose groups showed different degrees of increase of white blood cells