粒生素与惠尔血(rhG-CSF)对血液肿瘤患者化疗后粒细胞减少症的疗效比较

Therapeutic Effects on Chemotherapy-Induced Granulocytopenia in Hematologic Malignacies,a Comparison Between Lishengsu and Filgrastim

本研究采用多中心开放对照方法 ,观察了国产重组人粒细胞生长因子 (粒生素 )对血液系统恶性肿瘤化疗后引起的粒细胞减少症的治疗效果及不良反应 ,并与进口同类产品 (惠尔血 )进行比较 ,结果显示粒生素组和惠尔血组的总有效率相似 ,分别为 98.8%和 10 0 % ,且治疗后两组间外周血WBC ,ANC计数的变化曲线相似 ,均在用药后第 12天达到高峰 ,ANC计数恢复至正常所需的时间分别为 7天和 8天 ,无明显差异 ,表明在促进化疗后粒细胞减少症的恢复上 ,粒生素的疗效完全可以达到与惠尔血相同的水平。

A multi center,open controlled study was performed to observe the effects of Lishengsu, a rhG CSF preparation manufactured by Beijing Shuanglu Biopharmaceutical Co., Ltd. on chemotherapy induced granulocytopenia in patients with hematological malignancies. The results showed the total response rates were similar between Lishengsu and Filgrastim treated groups(98.8% vs 100%), recovery of peripheral ANC and WBC was also similar between the two groups,with the peaks appeared both at the 12th day after rhG CSF treatment. No differences were observed in the duration for ANC to recover to normal level between Lishengsu and Filgrastim treated groups(7 and 8 days respectively). Our results indicated Lishengsu is as effective as Filgrastim in accelerating the recovery of chemotherapy induced granulocytopenia.