新型粒细胞集落刺激因子——pegfilgrastim-jmdb
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摘要
Pegfilgrastim-jmdb是培非格司亭的第1种生物仿制药。2018年6月4日,美国食品药品监督管理局批准Mylan公司研发的pegfilgrastim-jmdb (商品名:Fulphila)上市。Pegfilgrastim-jmdb与靶细胞膜受体结合,产生粒细胞集落刺激因子,刺激粒细胞造血,用来降低非骨髓瘤患者骨髓抑制治疗中发热性中性粒细胞减少症的发生率。本文就pegfilgrastim-jmdb的作用机制、药动学、药物相互作用、临床试验及安全性等信息做一综述,以期为临床用药提供参考。
Pegfilgrastim-jmdb is the first approved biogenerics drug of pegfilgrastim, US Food and Drug Administration approves the listing of Mylan company Fulphila on June 4, 2018. Pegfilgrastim-jmdb binds to target cell membrane receptor to produce granulocyte colony stimulating factor to stimulate granulocyte hematopoiesis, which is used to reduce the incidence of febrile neutropenia in the treatment of myelosuppressive in non-myeloid cancer patients. This paper reviews the mechanism of action, pharmacokinetics, drug interactions, clinical trials and safety of pegfilgrastim-jmdb for clinical treatment.
Pegfilgrastim-jmdb is the first approved biogenerics drug of pegfilgrastim, US Food and Drug Administration approves the listing of Mylan company Fulphila on June 4, 2018. Pegfilgrastim-jmdb binds to target cell membrane receptor to produce granulocyte colony stimulating factor to stimulate granulocyte hematopoiesis, which is used to reduce the incidence of febrile neutropenia in the treatment of myelosuppressive in non-myeloid cancer patients. This paper reviews the mechanism of action, pharmacokinetics, drug interactions, clinical trials and safety of pegfilgrastim-jmdb for clinical treatment.
引文
[1]张国华,刘士霞,罗执芬.双铂联合方案治疗中晚期食管癌的临床观察[J].临床肿瘤学杂志,2003,8(2):50-51.
[2]张国楠.化疗药物引起的骨髓抑制[C]//中华妇产科杂志编辑部.第三届全国妇科恶性肿瘤化疗问题学术研讨会论文集.昆明:中华妇产科杂志编辑部,2011:93-98.
[3]何玉红.中性粒细胞减少症治疗新药pegfilgrastim[J].世界临床药物,2003,24(8):509.
[4]夏训明.美国FDA批准1种新的生物仿制药Fulphila(pegfilgrastim-jmdb)[J].广东药科大学学报,2018,34(3):364.
[5]李静,陶维良,魏世东,等.重组人粒细胞集落刺激因子(rhGCSF)的安全性与临床评价[J].中国医院用药评价与分析,2008,8(7):484-486.
[6] Nose J M,刘国元,管慧红.淋巴瘤化疗后使用Pegfilgrastim及每日使用非格司亭的比较:一项随机、多中心、开放性Ⅱ期试验研究[J].国外医学:内科学分册,2004,31(1):42-43.
[7] Holmes F A,Jones S E.O'Shaughnessy J,et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in, chemotherapy-induced neutropenia:a multicenter, dose-finding study in women with breast cancer[J]. Ann Oncol,2002,13(6):903-909.
[8] Australian Prescriber. Pegfilgrastim(pegylated filgrastim)[J].Aust Prescr,2002,25(6):147-151.
[9] Holmes F A, O'Shaughnessy J A,Vukelja S,et al. Blinded, randomized,multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stageⅡor stageⅢ/Ⅳbreast cancer[J]. J Clin Oncol,2002,20(3):727-731.
[10] Green M D,Koelbl H,Baselga J,et al. A randomized doubleblind multicenter phaseⅢstudy of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy[J]. Ann Oncol, 2003, 14(1):29-35.
[11] Vogel C L, Wojtukiewicz M Z,Carroll R R,et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer:a multicenter,double-blind,placebocontrolled phaseⅢstudy[J]. J Clin Oncol, 2005,23(6):1178-1184.
[12] Spunt S L,Hfrost I. PhaseⅡ, randomized, open-label study of pegfilgrastim-supported VDC/IE chemotherapy in pediatric sarcoma patients[J]. J Clin Oncol,2010,28(8):1329-1336.
[13] FDA. FULPHILA(pegfilgrastim-jmdb)tablets, for subcutaneous injection use[EB/0L].[2018-12-01]. https://www. accessdata. fda. gov/drugsatfda_docs/label/2018/761075s0001bl. pdf.
[14] Zagouri F, Maniou I. Supportive care during pregnancy[M]//Azim H A Jr. Managing cancer during pregnancy. Switzerland:Springer International Publishing,2016.
[15] Borinstein S C, Pollard J, Winter L,et al. Pegfilgrastim for prevention of chemotherapy-associated neutropenia in pediatric patients with solid tumors[J]. Pediatric Blood Cancer, 2010,53(3):375-378.
[2]张国楠.化疗药物引起的骨髓抑制[C]//中华妇产科杂志编辑部.第三届全国妇科恶性肿瘤化疗问题学术研讨会论文集.昆明:中华妇产科杂志编辑部,2011:93-98.
[3]何玉红.中性粒细胞减少症治疗新药pegfilgrastim[J].世界临床药物,2003,24(8):509.
[4]夏训明.美国FDA批准1种新的生物仿制药Fulphila(pegfilgrastim-jmdb)[J].广东药科大学学报,2018,34(3):364.
[5]李静,陶维良,魏世东,等.重组人粒细胞集落刺激因子(rhGCSF)的安全性与临床评价[J].中国医院用药评价与分析,2008,8(7):484-486.
[6] Nose J M,刘国元,管慧红.淋巴瘤化疗后使用Pegfilgrastim及每日使用非格司亭的比较:一项随机、多中心、开放性Ⅱ期试验研究[J].国外医学:内科学分册,2004,31(1):42-43.
[7] Holmes F A,Jones S E.O'Shaughnessy J,et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in, chemotherapy-induced neutropenia:a multicenter, dose-finding study in women with breast cancer[J]. Ann Oncol,2002,13(6):903-909.
[8] Australian Prescriber. Pegfilgrastim(pegylated filgrastim)[J].Aust Prescr,2002,25(6):147-151.
[9] Holmes F A, O'Shaughnessy J A,Vukelja S,et al. Blinded, randomized,multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stageⅡor stageⅢ/Ⅳbreast cancer[J]. J Clin Oncol,2002,20(3):727-731.
[10] Green M D,Koelbl H,Baselga J,et al. A randomized doubleblind multicenter phaseⅢstudy of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy[J]. Ann Oncol, 2003, 14(1):29-35.
[11] Vogel C L, Wojtukiewicz M Z,Carroll R R,et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer:a multicenter,double-blind,placebocontrolled phaseⅢstudy[J]. J Clin Oncol, 2005,23(6):1178-1184.
[12] Spunt S L,Hfrost I. PhaseⅡ, randomized, open-label study of pegfilgrastim-supported VDC/IE chemotherapy in pediatric sarcoma patients[J]. J Clin Oncol,2010,28(8):1329-1336.
[13] FDA. FULPHILA(pegfilgrastim-jmdb)tablets, for subcutaneous injection use[EB/0L].[2018-12-01]. https://www. accessdata. fda. gov/drugsatfda_docs/label/2018/761075s0001bl. pdf.
[14] Zagouri F, Maniou I. Supportive care during pregnancy[M]//Azim H A Jr. Managing cancer during pregnancy. Switzerland:Springer International Publishing,2016.
[15] Borinstein S C, Pollard J, Winter L,et al. Pegfilgrastim for prevention of chemotherapy-associated neutropenia in pediatric patients with solid tumors[J]. Pediatric Blood Cancer, 2010,53(3):375-378.