国产基因重组人粒细胞集落刺激因子Ⅱ期临床研究报告

Phase Ⅱ clinical trial of five domestic-made rhG-CSFs

目的 对五家单位生产的 rh G- CSF进行疗效及毒副作用的 期临床研究。方法 观察 6 0例病人 ,随机分组 ,采用自身交叉方法。结果 五个 rh G- CSF均可明显升高 ANC和 WBC,升高曲线呈双峰状态 ,可促进化疗病人 WBC和 ANC的恢复 ,缩短 WBC和 ANC减少的持续时间 ;对血红蛋白和血小板未见明显影响。主要不良反应有发热、局部反应、感冒样症状、骨肌肉疼痛和皮疹等。五个产品在疗效和不良反应方面无明显差别。结论 国产rh G- CSF可促进化疗病人 WBC和 ANC的恢复 ,缩短 WBC和 ANC减少的持续时间 ,使用安全有效 ,是一种高剂量化疗中有效的辅助药物。

Objective To evaluate the therapeutic effectiveness and the side effects of five rhG CSFs produced by different domestic companies.Methods Sixty patients were grouped randomly.Self cross control was made.Results All five rhG CSFs can elevate the ANC and the WBC.The elevation curves were double peak.They facilitated the patients' recovery from the chemotherapy,shortened the period of the decrease of the WBC and the ANC,and no effects were observed on haemoglobin and platelet in evidence.The major side effects were fever,local reaction,rheum like symptom,myalgia,eryption and so on.No differences were observed among these productions in effective and side effects.Conclusion All these five rhG CSFs made by domestic companies are helpful for the WBC and ANC's recovery of the patients treated by chemotherapy.They can shorten the period of low WBC and ANC safely and efficiency.