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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 investigate the curative effect and toxic side effects of rh G-CSF produced by five units in a clinical trial. Methods Sixty patients were observed, randomly divided into groups, using their own cross method. Results All of rhG-CSF could significantly increase the levels of ANC and WBC, and the peak of the curve was bimodal, which could promote the recovery of WBC and ANC in chemotherapy patients and shorten the duration of WBC and ANC reduction. No obvious hemoglobin and platelet influences. The main adverse reactions are fever, local reactions, flu-like symptoms, bone muscle pain and rash. Five products in the efficacy and adverse reactions no significant difference. Conclusion Domestic rhG-CSF can promote the recovery of WBC and ANC in chemotherapy patients, shorten the duration of WBC and ANC reduction, and is safe and effective. It is an effective adjuvant in high-dose chemotherapy.