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目的:为研究国产重组人粒细胞巨噬细胞集落刺激因子(rh G M_ C S F, 商品名里亚尔) 防治实体瘤化疗所致白细胞( W B C) 和绝对中性粒细胞计数( A N C) 减少的临床效果及不良反应。方法:采用多中心随机分组、自身交叉对照方法,进行了临床 I I期试验。60 例肿瘤化疗病人随机均分 A B 组和 B A组。 A B 组第1 周期化疗加rh G M_ C S F 治疗( 治疗组) ,第2 周期单用化疗( 对照组) ; B A 组第1 周期单用化疗,第2 周期化疗加rh G M_ C S F 治疗。56 例可供临床疗效分析。结果:rh G M_ C S F 可减轻化疗所致 W B C 和 A N C 下降程度,缩短 W B C 和 A N C 降至正常值以下的持续时间,促进 W B C 和 A N C 减少的早日恢复,有助于化疗按期进行。主要不良反应有轻、中度发热,注射部位疼痛,骨、肌肉疼痛,乏力。少见的有皮疹、寒战、流涕、胸闷、心悸,一般可以耐受。结论:rh G M_ C S F 是有价值的化疗辅助药物。
OBJECTIVE: To study the effects of rhG M_CSF (product name: Rar) on the counts of white blood cells (W B C) and absolute neutrophils (A N C) to reduce the clinical effects and adverse reactions. Methods: A multicenter randomized, self-controlled crossover study was conducted to evaluate clinical phase I-phase I disease. Sixty patients with tumor chemotherapy were randomly divided into group A B and group B A. Group A was treated with rhG M-CSF at the first cycle and treated with rhG M-CSF at the second cycle (control group). Group B was treated with chemotherapy alone at the first cycle and chemotherapy with rhG M_C at the second cycle S F treatment. 56 cases for clinical efficacy analysis. RESULTS: rhG M_CSF reduced the decline of chemotherapy-induced W B C and A N C, shortened the duration of W B C and A N C reduction to below normal, and promoted the reduction of W B C and A N C Early recovery, to help chemotherapy on schedule. The main adverse reactions are mild to moderate fever, injection site pain, bone, muscle pain, fatigue. Rare rash, chills, runny nose, chest tightness, palpitations, generally tolerated. Conclusion: rh G M C F is a valuable adjunct to chemotherapy.