【摘要】 目的探讨聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)对同期放化疗所致Ⅲ度粒细胞缺乏患者挽救性治疗的疗效及不良反应,为其在临床中合理应用提供依据。方法对105例同期放化疗所致Ⅲ度粒细胞缺乏的恶性肿瘤患者进行分析,试验组包括:PEG-50组38例、PEG-100组26例、PEG-R组21例,给药方式依次为PEGrhG-CSF 50μg/kg单次皮下注射,100μg/kg单次皮下注射,PEG-rhG-CSF 50μg/kg单次皮下注射+rhG-CSF5μg·kg-1·d-1皮下注射,外周血中性粒细胞绝对计数(ANC)≥2.0×109/L后停用rhG-CSF;对照组为R组20例,即rhG-CSF 5μg·kg-1·d-1皮下注射,ANC≥2.0×109/L后停用。对上述4组患者的时间—中性粒细胞增殖率、时间—ANC值、粒细胞缺乏所致不良症状的缓解时间、药物不良反应发生率进行统计学分析。结果试验组中性粒细胞增殖率和中性粒细胞绝对值均较对照组显著增高(P<0.05),各试验亚组的临床效应发挥均始于用药12~24 h,于24 h左右达到改善粒细胞缺乏的治疗目的,P-50组与P+R组的时间-中性粒细胞增殖率和时间-ANC值无明显差异(P>0.05);试验组与对照组缓解因粒细胞缺乏所致临床症状所需的时间无明显差异(P>0.05)。结论 PEG-rhG-CSF对于同期放化疗所致Ⅲ度粒细胞缺乏患者的挽救性治疗推荐剂量为单次50μg/kg皮下注射,其效应发挥时间始于12~24 h之后,如果在此期间ANC值无明显提高,无需加用rhG-CSF。更多还原

【Abstract】 Objective To investigate the therapeutic effect and adverse reaction of salvage therapy of pegylated recombinant human granulocyte colony stimulating factor( PEG-rhG-CSF) on degree Ⅲ neutropenia induced by radiotherapy and chemotherapy in synchronism in order to provide basis for reasonable application of PEG-rhG-CSF in clinic. Methods The data about 105 patients with degree Ⅲ neutropenia caused by radiotherapy and chemotherapy in synchronism were analyzed. The experimental groups included group PEG50( n = 38),group PEG100( n = 26),group PEG + R( n = 21).The patients in the three groups were given respectively with a single injection of PEG-rhG-CSF 50μg /kg,a single injection of PEG-rhG-CSF 100μg /kg,a single injection of PEG-rhG-CSF 50μg /kg plus multiple injections of rhG-CSF 5μg·kg-1·d-1,until the absolute neutrophil count( ANC) ≥2. 0 × 109/L. The 20 patients in control group received multiple injections of rhG-CSF 5μg·kg-1·d-1,untill ANC ≥2.0 ×109/L. The time-neutrophil proliferation rate,time-ANC,the time of symptom relief,the incidence of drug adverse reaction were statistically analyzed. Results The time-neutrophil proliferation rate,time-ANC in experimental group were significantly increased,as compared with those in control group( P<0. 05). The starting time of clinical effect in experimental groups began during 12 ~ 24 hours,and the symptoms of neutropenia were improved about 24 hours. There were no significant differences in the time-neutrophil proliferation rate and time-ANC between the PEG50 group and PEG + R group( P>0. 05). There was no significant difference in the time of symptom relief between experimental group and control group( P>0. 05). Conclusion The recommended dose of PEG-rhG-CSF in salvage treatment of degree Ⅲ neutropenia is single subcutaneous injection of 50μg /kg,its clinical effects start after 12 ~ 24 hours,and it need not to reinforce rhG-CSF if ANC has no obvious enhancement during this period.更多还原