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培格非格司亭在化疗所致中性粒细胞减少症中的应用:中国的使用概况。

Mecapegfilgrastim in Chemotherapy-Induced Neutropenia: A Profile of Its Use in China.

机构信息

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Clin Drug Investig. 2019 Oct;39(10):1009-1018. doi: 10.1007/s40261-019-00836-y.

Abstract

Mecapegfilgrastim (HHPG-19K) is a long-acting pegylated recombinant human granulocyte-colony stimulating factor (rhG-CSF) that is administered subcutaneously as prophylaxis once per chemotherapy cycle as a weight-adjusted dose of 100 µg/kg or as a 6 mg fixed dose. It is approved in China to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy associated with a clinically significant incidence of febrile neutropenia. In phase III trials, once per cycle prophylaxis with mecapegfilgrastim was more effective than placebo in reducing the incidence of grade ≥ 3 neutropenia in cycle 1 in patients with advanced non-small cell lung cancer and was more effective than filgrastim at reducing the mean duration of grade ≥ 3 neutropenia in cycle 1 in patients with breast cancer. The tolerability and safety profiles of mecapegfilgrastim were similar to those of filgrastim, with no unexpected adverse events (AEs); most adverse reactions in cycle 1 were mild or moderate in severity. Thus, mecapegfilgrastim is an effective and generally well tolerated treatment option for patients with non-myeloid malignancies receiving myelosuppressive chemotherapy, and extends the options available for managing chemotherapy-induced neutropenia in China.

摘要

美倍格(HHPG-19K)是一种长效聚乙二醇化重组人粒细胞集落刺激因子(rhG-CSF),作为预防措施,每化疗周期皮下给药一次,根据体重调整剂量为 100μg/kg,或给予固定剂量 6mg。该药在中国获批用于降低非髓性恶性肿瘤患者接受骨髓抑制性抗癌治疗相关的感染发生率,表现为发热性中性粒细胞减少症,此类治疗具有发热性中性粒细胞减少症的临床显著发生率。在 III 期临床试验中,与安慰剂相比,每周期给予美倍格的预防性治疗在晚期非小细胞肺癌患者第 1 周期中更有效降低了≥3 级中性粒细胞减少症的发生率,在乳腺癌患者中也更有效降低了第 1 周期中≥3 级中性粒细胞减少症的平均持续时间。美倍格的耐受性和安全性特征与非格司亭相似,无意外不良事件(AE);第 1 周期的大多数不良反应严重程度为轻度或中度。因此,美倍格是接受骨髓抑制性化疗的非髓性恶性肿瘤患者的一种有效且通常耐受良好的治疗选择,在中国为管理化疗诱导性中性粒细胞减少症提供了更多选择。

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