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目的:考察3个剂量组临床应用华北吉姆欣(重组人粒细胞巨噬细胞集落刺激因子,rhGMCSF)的不良反应,评价其临床使用的安全性。方法:9例恶性肿瘤患者,化疗后按25,50,75μg/kg3个剂量组,皮下注射华北吉姆欣,每组3例病人,实际用药剂量150~600μg/d(相当于242~759μg/kg),qd,连用7d。结果:9例患者均按计划安全完成临床试验,主要不良反应为乏力、肌肉酸痛、骨痛、发热,但均可耐受,不同剂量组之间不良反应发生率和发生程度差异不显著。与相同病人另一化疗周期比较,化疗后加rhGMCSF对化疗后白细胞下降有促进恢复的作用。结论:华北吉姆欣临床使用安全,对化疗后白细胞下降有治疗作用。
Objective: To investigate the clinical application of three dose groups of North China Jim Yan (recombinant human granulocyte-macrophage colony stimulating factor, rhGM CSF) adverse reactions to evaluate the safety of its clinical use. Methods: Nine patients with malignant tumor were treated with 3, 5, 5, 7 and 5 μg / kg dose of 3 doses after chemotherapy, and 3 patients in each group were injected subcutaneously with the actual dose of 150 ~ 600 μg / d In 2 42 ~ 7 59μg / kg), qd, once every 7d. Results: All the 9 patients completed the clinical trial safely. The main adverse reactions were fatigue, muscle soreness, bone pain and fever, but all were tolerable. There was no significant difference in the incidence and occurrence of adverse reactions between different dosage groups. With the same patient another chemotherapy cycle, chemotherapy plus rhGM-CSF after chemotherapy to promote leukopenia recovery role. Conclusion: The clinical use of Jim Hsien in North China is safe and has a therapeutic effect on leukopenia after chemotherapy.