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首页> 外文期刊>Future oncology >Biosimilar medicines in oncology: Single-center experience with biosimilar G-CSF
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Biosimilar medicines in oncology: Single-center experience with biosimilar G-CSF

机译：肿瘤学中的生物仿制药：生物仿制药G-CSF的单中心经验

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Aims: A biosimilar medicine is one with proven similarity to a reference biological product for which the patent has expired and whose active ingredient is produced or derived from a living organism. Recombinant granulocyte colony-stimulating growth factors (G-CSF) are used for the prophylaxis of febrile neutropenia. Materials & methods: In this observational, single-center study, a total of 48 patients with solid tumors were treated with a new biosimilar G-CSF (Zarzio ?) for 4-14 days from the day following the end of chemotherapy. Results: Between October 2010 and July 2011, biosimilar G-CSF was administered as primary prophylaxis in 37 patients and as secondary prophylaxis in 11 patients in our clinic. The median length of G-CSF administration was 7 days (range: 1-12 days). Three cases of febrile neutropenia were reported: two in patients with prostate adenocarcinoma and one in a patient with pulmonary squamous cell carcinoma and multiple secondary skeletal lesions. These patients were treated with antibiotics and improved within 24 h without the need for hospitalization. Nonfebrile grade 4 neutropenia was observed in a further six patients. Conclusion: Our experience indicates that the use of biosimilar G-CSF is safe and effective at reducing neutropenic complications in patients with solid tumors and may be associated with cost savings.
机译：目的：生物仿制药是一种与参考生物产品具有相似性的药物，该专利已过期，并且其活性成分是从活生物体生产或衍生的。重组粒细胞集落刺激生长因子（G-CSF）用于预防发热性中性粒细胞减少症。材料与方法：在这项观察性，单中心研究中，从化疗结束后的第二天起，总共有48位实体瘤患者接受了新型生物仿制药G-CSF（Zarzio？）的治疗，时间为4-14天。结果：从2010年10月至2011年7月，我们在本诊所中对37例患者进行了生物仿制药G-CSF的一级预防，对11例患者进行了二级预防。 G-CSF给药的中位时间为7天（范围：1-12天）。报告了三例发热性中性粒细胞减少症：前列腺腺癌患者2例，肺鳞癌和多发继发性骨骼病变的患者1例。这些患者接受了抗生素治疗，并在24小时内得到了改善，无需住院。在另外六名患者中观察到非发热性4级中性粒细胞减少症。结论：我们的经验表明，使用生物仿制药G-CSF可以安全有效地减少实体瘤患者的中性粒细胞减少并发症，并可能节省成本。

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