预防性应用rhG-CSF的随机自身对照研究

A Randomized and Controlled Study of rhG-CSF on Prevention of Leucopenia induced by Chemotherapy

目的 :探讨预防性应用rhG CSF在肿瘤化疗中的临床意义。方法 :采用随机自身交叉对照的方法 ,将化疗患者分成AB和BA两组 ,A(周期 )组为预防组 ,在化疗结束 4 8小时后预防性应用rhG CSF 5 μg/kg ,皮下注射 ,连用 5～ 1 4天 ;B(周期 )组为对照组 ,在WBC总数≤ 4 0× 1 0 9/L时 ,应用rhG CSF ,剂量用法同A组。比较化疗第 2 1、2 8序日时的WBC总数的差异。结果 :预防组WBC(平均值 )在整个化疗期间均在正常值 (4 0× 1 0 9/L)以上 ,波动幅度相对较小 ;对照组则于化疗第1 4序日低于正常 ,持续低于正常的中位时间约 7天左右。但在 2 1、2 8序日两组的WBC总数并无统计学差异 (P >0 0 5 )。两种治疗方法对维持WBC的正常无显著性差异 (P >0 0 5 )。结论 :尚无足够的证据说明预防性应用rhG CSF可以作为化疗患者的常规使用 。

Objective:To investigate the preventive value of recombinant human granulocyte colony stimulating factor (rhG CSF) in cancer patients.Methods:98 patients with maliganacies confirmed by pathology or cytology were divided into AB or BA groups randomly. All cases were controlled to themselves. Patients were given a preventive cutaneous injection of rhG CSF after 48 hours of chemotherapy in A cycles. While given injection of rhG CSF only when the count of white bolld cell (WBC) was below 4 0 ×10 9/L in B cycles. The differences of WBC counts on 21st, 28th day were studied statistically.Results:The mean WBC counts are above the normal level of 4 0×10 9/L in A group, while below the normal level on 14th day in B group during the chemotherapy. The median duration of leucopenia is 7 days. There is no significant difference of the counts of WBC or the cases of normal WBC count on 21st, 28th day between A and B groups.Conclusion:There is no enough proof to recommend the preventive application of rhG CSF as a routine in chemotherapy patients.