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在临床Ⅰ期研究中已证实GM-CSF以500μg和750μg/m~2·d分次SC,是支持环磷酸胺、Vp16和卡铂强烈化疗(DICEP)的最佳方案,能够缩短住院天数,降低因粒细胞减少发热而再入院的发生率。本研究应用GM-CSF与安慰剂双盲对照法评价GM-CSF 500μg/m~2·d SC。对支持DICEP化疗方案的疗效和安全性。 病人选择 两组晚期乳腺癌或非霍奇金淋巴瘤患者在年龄、性别和疾病类型上是匹配的;所有患者Hb>100g/L、ANC>1.5×10~9/L,Plt>100×10~9/L,Scr<140μmol/L,S_(BUN)<26μmol/L,肺弥散功能>预计值的60％,治疗前未接受过强烈化疗和造血生长因子。
In clinical phase I studies, GM-CSF has been shown to have fractional SCs of 500 μg and 750 μg/m~2·d, which is the best solution to support cyclic phosphoamine, Vp16 and carboplatin intensive chemotherapy (DICEP), and can shorten hospitalization days. Decrease the incidence of rehospitalization due to fever caused by neutropenia. In this study, GM-CSF and placebo were used to evaluate GM-CSF 500 μg/m~2·d SC. Supports DICEP chemotherapy regimen efficacy and safety. Patients selected between the two groups of patients with advanced breast or non-Hodgkin lymphoma were matched in age, gender and disease type; all patients Hb> 100g / L, ANC> 1.5 × 10 ~ 9 / L, Plt> 100 × 10 ~9/L, Scr <140 μmol/L, S_(BUN) <26 μmol/L, pulmonary diffusing capacity> 60% of predicted value, no strong chemotherapy and hematopoietic growth factors before treatment.