G-CSF/GM-CSF序贯给药与G-CSF单药防治化疗后骨髓抑制的对比研究

Randomized Comparative Study of Sequential G /GM-CSF or G-CSF alo ne in the Treatment of Chemotherapy-Induced Myelosuppression

目的:对比研究低剂量G-CSF/GM-CSF序贯给药与G-CSF单药预防化疗所致白细胞减少、血小板降低的临床效果及不良反应。方法:采用随机单盲研究方法,将50例肿瘤化疗患者随机分成A组和B组。A组于化疗后第7～9日皮下注射G-CSF,10～12日皮下注射GM-CSF(均为2.5μg/kg);B组化疗后第7～12日皮下注射G-CSF(2.5μg/kg)。结果:G/GM-CSF序贯给药和G-CSF单药均可明显减轻化疗所致WBC和ANC的下降程度,降低化疗延迟率及延迟时间,提高化疗完成率。G/GM-CSF序贯给药还可以提高化疗后的单核细胞和血小板的数量,减少血小板成分输血。主要不良反应如发热,注射部位疼痛,骨骼肌肉疼痛等两组相似,且可以耐受。结论:序贯联合应用低剂量G-CSF和GM-CSF可有效防治白细胞、血小板的降低,减少成分输血的次数,提高化疗完成率,是防治化疗所致骨髓抑制有效的方法。

Objective:To evaluate the clinical effects and side-effects of sequential G/GM-CSF or G-CSF alone in treatment of chemotherapy-induced leucopenia and thrombocytopenia.Methods:A randomized single blind clinical trial was conducted.Fifty enrolled patients were randomized into A and B groups.The A group,from the7-9th day after the chemotherepy,G-CSF,2.5μg/kg /day s.c.and10-12th day,GM-CSF,2.5μg/kg /day s.c.and the B group,from the7-9th day of the cycle,G-CSF,2.5μg/kg /day s.c.were performed.Results:Both se quential administration of G/GM-CSF or G-CSF alone increased the number of total WBC count and ab-solute neutrophil count,and decreased the incidence of delayed chemotherapy and shortened the time of delay.CSF ensured the scheduled chemotherapy.Sequential administration of G/GM-CSF raised the number of mononuclear cells and shortened the time of thrombocy topenia and de-creased the number of plt transfusions.The main side-effects of fever,pain at the in jection site,bone pain,myoalgia were similar in both groups and tolerable.Conclusion:Low dose combi -natied sequential administration of G/GM-CSF is a valuable adjunct therapy for chemothera py-induced myelosuppression.