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高三尖杉酯碱/奥曲肽琥珀酸酯：通往食品和药物管理局批准的漫长曲折之路。

Homoharringtonine/omacetaxine mepesuccinate: the long and winding road to food and drug administration approval.

机构信息

The University of Texas M.D. Anderson Cancer Center, Department of Leukemia, Houston, TX.

出版信息

Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):530-3. doi: 10.1016/j.clml.2013.03.017. Epub 2013 Jun 20.

DOI:10.1016/j.clml.2013.03.017
PMID:23790799
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3775965/
Abstract

Homoharringtonine/omacetaxine is a unique agent with a long history of research development. It has been recently approved by the Food and Drug Administration for the treatment of chronic myeloid leukemia after failure of 2 or more tyrosine kinase inhibitors. Research with this agent has spanned over 40 years, with many instructive lessons to cancer research, which are summarized in this review.

摘要

高三尖杉酯碱/奥马环素是一种具有悠久研究开发历史的独特药物。最近，它已被美国食品和药物管理局批准用于治疗 2 种或以上酪氨酸激酶抑制剂治疗失败后的慢性髓性白血病。对该药物的研究已经跨越了 40 多年，为癌症研究提供了许多有益的经验教训，本综述对此进行了总结。

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Homoharringtonine/omacetaxine mepesuccinate: the long and winding road to food and drug administration approval.高三尖杉酯碱/奥曲肽琥珀酸酯：通往食品和药物管理局批准的漫长曲折之路。
Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):530-3. doi: 10.1016/j.clml.2013.03.017. Epub 2013 Jun 20.
2
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本文引用的文献

1
Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre, open-label, randomised, controlled phase 3 trial.基于高三尖杉酯碱的诱导方案治疗初发急性髓系白血病患者的多中心、开放标签、随机、对照 3 期临床试验。
Lancet Oncol. 2013 Jun;14(7):599-608. doi: 10.1016/S1470-2045(13)70152-9. Epub 2013 May 9.
2
Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation.T315I 突变的慢性期 CML 患者 TKI 治疗失败后皮下注射奥马曲星的 2 期研究。
Blood. 2012 Sep 27;120(13):2573-80. doi: 10.1182/blood-2012-03-415307. Epub 2012 Aug 15.
3
Homoharringtonine, omacetaxine mepesuccinate, and chronic myeloid leukemia circa 2009.高三尖杉酯碱、奥马环素甲磺酸盐和 2009 年前后的慢性髓性白血病。
Cancer. 2009 Dec 1;115(23):5382-93. doi: 10.1002/cncr.24601.
4
Effect of low-dose cytarabine, homoharringtonine and granulocyte colony-stimulating factor priming regimen on patients with advanced myelodysplastic syndrome or acute myeloid leukemia transformed from myelodysplastic syndrome.小剂量阿糖胞苷、高三尖杉酯碱联合粒细胞集落刺激因子预处理方案对骨髓增生异常综合征或骨髓增生异常综合征转化的急性髓系白血病患者的疗效。
Leuk Lymphoma. 2009 Sep;50(9):1461-7. doi: 10.1080/10428190903096719.
5
Intensive induction chemotherapy with regimen containing intermediate dose cytarabine in the treatment of de novo acute myeloid leukemia.含中剂量阿糖胞苷方案的强化诱导化疗治疗初治急性髓系白血病
Am J Hematol. 2009 Jul;84(7):422-7. doi: 10.1002/ajh.21441.
6
Inhibitory effects of omacetaxine on leukemic stem cells and BCR-ABL-induced chronic myeloid leukemia and acute lymphoblastic leukemia in mice.奥马西他辛对小鼠白血病干细胞以及BCR-ABL诱导的慢性髓性白血病和急性淋巴细胞白血病的抑制作用。
Leukemia. 2009 Aug;23(8):1446-54. doi: 10.1038/leu.2009.52. Epub 2009 Mar 26.
7
A phase II study of continuous infusion homoharringtonine and cytarabine in newly diagnosed patients with chronic myeloid leukemia: CALGB study 19804.一项关于持续输注高三尖杉酯碱和阿糖胞苷治疗新诊断慢性髓性白血病患者的II期研究：癌症和白血病B组研究19804
Cancer Chemother Pharmacol. 2009 Apr;63(5):859-64. doi: 10.1007/s00280-008-0805-8. Epub 2008 Aug 1.
8
Interferon-alpha or homoharringtonine as salvage treatment for chronic myeloid leukemia patients who acquire the T315I BCR-ABL mutation.干扰素-α或高三尖杉酯碱作为获得T315I BCR-ABL突变的慢性髓性白血病患者的挽救治疗。
Blood. 2007 Oct 1;110(7):2779-80. doi: 10.1182/blood-2007-06-094508.
9
BCR-ABL(T315I) transcript disappearance in an imatinib-resistant CML patient treated with homoharringtonine: a new therapeutic challenge?用高三尖杉酯碱治疗的伊马替尼耐药慢性粒细胞白血病患者中BCR-ABL（T315I）转录本消失：一个新的治疗挑战？
Leukemia. 2007 Oct;21(10):2204-6. doi: 10.1038/sj.leu.2404772. Epub 2007 May 31.
10
Phase I/II study of subcutaneous homoharringtonine in patients with chronic myeloid leukemia who have failed prior therapy.皮下注射高三尖杉酯碱用于既往治疗失败的慢性髓性白血病患者的I/II期研究。
Cancer. 2007 Jan 15;109(2):248-55. doi: 10.1002/cncr.22398.