rhG-CSF预防化疗后粒细胞减少的Ⅱ期临床试验  

Phase ⅡClinical Trials on rhG-CSF in Prevention of Leukopenia after Chemotherapy

作　　者：陈玲[1] 张沂平[1] 徐农[2] 李铁[1] 施勋[1] 

机构地区：[1]浙江省肿瘤医院,浙江杭州310022 [2]浙江大学医学院附属第一医院,浙江杭州310009

出　　处：《肿瘤学杂志》2002年第1期22-23,共2页Journal of Chinese Oncology

摘　　要：[目的]评价InstitutoSidusS.A.生物公司生产的若美斯(rhG CSF)对防治化疗后粒细胞减少症的作用及不良反应。[方法]采用随机分组的方法 ,将34例患者分为AB组和BA组。AB组第一周期(A周期)化疗48h后加用G CSF ,第二周期为空白对照周期(B周期) ,仅单独使用化疗 ;BA组与上相反。rhG CSF在化疗药物末次给药后48h起 ,5μg/kg,皮下注射 ,每日1次。同时观察患者血中白细胞(WBC)值及中性粒细胞(ANC)值变化。[结果]运用rhG CSF支持后的研究组和对照组相比 ,化疗后WBC值<1×109/L,2×109/L,3×109/L ,4×109/L的持续平均天数明显减少(P<0.05,P<0.01)。ANC值<0.5×109/L,1.0×109/L,1.5×109/L ,2.0×109/L的持续平均天数也明显减少(P<0.05,P<0.01) ,并能减少感染和运用其他抗生素的几率 ,用药后白细胞值及中性粒细胞值在d2 出现第1个高峰、d8 出现第2个高峰。rhG CSF对血小板无明显影响。不良反应表现为 :30%的病人出现轻中度的骨骼肌疼痛 ,6%出现轻度乏力 ,6%出现轻度局部注射痛 ,一般不需特殊处理 ,易于耐受。[结论]rhG CSF可以促进化疗病人WBC和ANC的恢复 ,安全性好 ,可作为化疗提高剂量的辅助用药。To evaluate the efficacy and adverse effects of Ruo Mei Si(rhG CSF)in chemotherapy induced leukopenia and neutropenia.Thirty four patients were randomly divided into AB and BA groups.AB group was treated with chemotherapy plus rhG CSF and chemotherapy alone in the 1st and 2nd cycles respectively.The treatment of BA groups was just contrary to AB group.rhG CSF at a dosage of 5μg/kg,qd was subcutaneously injected 48h after the last administration of chemotherapeutic agents.The value of WBC count and ANC count were assayed accordingly.rhG CSF significantly reduced the severity and the duration of leukopenia and neutrophilic granulocytopenia,the incidence of infection,and the chance of antibiotic administration.ANC increased rapidly with the first peak after d2 of rhG CSF injection.The second peak occurred at the d8.rhG CSF had no effects on platelet.rhG CSF caused some side effects including slight bone pain(30%),fatigue(6%),and local pain of the injection site(6%).These symptoms were toleable.[Conclusion]rhG CSF plays an important role in accelerating the recovery of leukopenia and neutsophilic granunlocytopenia induced by chemotherapy.It is also safe to patients.We suggest that rhG CSF is a favorably adjuvant drug in the high dose intensive chemotherapy.

关 键 词：重组人粒细胞集落刺激因子 药物疗法 中性粒细胞 疗效 临床试验 若美斯 粒细胞减少症 不良反应 

分 类 号：R73－36[医药卫生—肿瘤] R730.53[医药卫生—临床医学]