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《奥妥珠单抗短程输注中国专家共识(2024年版)》

[Chinese expert consensus on short duration infusion of obinutuzumab (2024)].

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2024 Oct 14;45(10):897-901. doi: 10.3760/cma.j.cn121090-20240704-00250.

DOI:10.3760/cma.j.cn121090-20240704-00250
PMID:39622752
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11579752/
Abstract

Obinutuzumab has been widely used in patients with CD20 positve B-cell non-Hodgkin's lymphoma for more than 10 years since its launch, bringing significant clinical benefits. At present, studies at home and abroad have confirmed that the 90-minute short duration infusion of obinutuzumab is safe and feasible.In order to improve the convenience of patient infusion and the efficiency of medical institutions'infusion facilities, it is recommended for patients who do not experience grade ≥3 infusion-related adverse reactions in the first cycle of obinutuzumab infusion at the standard rate, a short duration infusion scheme should be used for subsequent treatment courses. This expert consensus is formulated to provide guidance for clinical practice.

摘要

奥妥珠单抗自上市以来已在CD20阳性B细胞非霍奇金淋巴瘤患者中广泛应用超过10年,带来了显著的临床获益。目前,国内外研究已证实奥妥珠单抗90分钟短程输注安全可行。为提高患者输注便利性及医疗机构输注设施使用效率,对于在首次以标准速率输注奥妥珠单抗时未发生≥3级输注相关不良反应的患者,建议后续疗程采用短程输注方案。制定本专家共识旨在为临床实践提供指导。

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1
[Chinese expert consensus on short duration infusion of obinutuzumab (2024)].《奥妥珠单抗短程输注中国专家共识(2024年版)》
Zhonghua Xue Ye Xue Za Zhi. 2024 Oct 14;45(10):897-901. doi: 10.3760/cma.j.cn121090-20240704-00250.
2
Safety, tolerability and pharmacokinetics of shorter duration of infusion of obinutuzumab in Japanese patients with B-cell non-Hodgkin lymphoma: final results of the phase II GATS study.在日本 B 细胞非霍奇金淋巴瘤患者中,奥滨尤妥珠单抗较短输注时间的安全性、耐受性和药代动力学:GATS 研究的最终结果。
Jpn J Clin Oncol. 2018 Aug 1;48(8):736-742. doi: 10.1093/jjco/hyy087.
3
Safety of a 90-min duration of intravenous infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma in a tertiary hospital in China: a prospective, open-label, exploratory clinical trial.在中国一家三级医院中,对患有 B 细胞非霍奇金淋巴瘤的患者进行静脉输注奥滨尤妥珠单抗 90 分钟的安全性:一项前瞻性、开放标签、探索性临床试验。
Braz J Med Biol Res. 2024 Feb 9;57:e13284. doi: 10.1590/1414-431X2023e13284. eCollection 2024.
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Randomized Phase II Trial Comparing Obinutuzumab (GA101) With Rituximab in Patients With Relapsed CD20+ Indolent B-Cell Non-Hodgkin Lymphoma: Final Analysis of the GAUSS Study.比较奥滨尤妥珠单抗(GA101)与利妥昔单抗治疗复发的CD20+惰性B细胞非霍奇金淋巴瘤患者的随机II期试验:GAUSS研究的最终分析
J Clin Oncol. 2015 Oct 20;33(30):3467-74. doi: 10.1200/JCO.2014.59.2139. Epub 2015 Aug 17.
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Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial.奥滨尤妥珠单抗联合苯达莫司汀对比苯达莫司汀单药治疗利妥昔单抗难治性惰性非霍奇金淋巴瘤(GADOLIN):一项随机、对照、开放标签、多中心、3 期临床试验。
Lancet Oncol. 2016 Aug;17(8):1081-1093. doi: 10.1016/S1470-2045(16)30097-3. Epub 2016 Jun 23.
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Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia.利妥昔单抗:用于非霍奇金淋巴瘤和慢性淋巴细胞白血病的综述
Drugs. 2003;63(8):803-43. doi: 10.2165/00003495-200363080-00005.
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Obinutuzumab (GA101) for the treatment of chronic lymphocytic leukemia and other B-cell non-hodgkin's lymphomas: a glycoengineered type II CD20 antibody.奥滨尤妥珠单抗(GA101)治疗慢性淋巴细胞白血病和其他 B 细胞非霍奇金淋巴瘤:一种糖基化工程化的 II 型 CD20 抗体。
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J Clin Oncol. 2018 Aug 1;36(22):2259-2266. doi: 10.1200/JCO.2017.76.3656. Epub 2018 Mar 27.
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Near-infrared fluorescence imaging of non-Hodgkin's lymphoma CD20 expression using Cy7-conjugated obinutuzumab.使用Cy7偶联的奥妥珠单抗对非霍奇金淋巴瘤CD20表达进行近红外荧光成像。
Mol Imaging Biol. 2014 Dec;16(6):877-87. doi: 10.1007/s11307-014-0742-3.

本文引用的文献

1
Evaluation of safety outcomes with transitioning obinutuzumab from standard rate to short duration infusion in patients with chronic lymphocytic leukemia.评估慢性淋巴细胞白血病患者将奥妥珠单抗从标准输注速率转换为短疗程输注后的安全性结果。
Leuk Lymphoma. 2024 Aug;65(8):1198-1199. doi: 10.1080/10428194.2024.2341999. Epub 2024 Apr 22.
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Safety of a 90-min duration of intravenous infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma in a tertiary hospital in China: a prospective, open-label, exploratory clinical trial.在中国一家三级医院中,对患有 B 细胞非霍奇金淋巴瘤的患者进行静脉输注奥滨尤妥珠单抗 90 分钟的安全性:一项前瞻性、开放标签、探索性临床试验。
Braz J Med Biol Res. 2024 Feb 9;57:e13284. doi: 10.1590/1414-431X2023e13284. eCollection 2024.
3
Obinutuzumab Can Be Administered as a 90-minute Short Duration Infusion in Patients With Previously Untreated Follicular Lymphoma: GAZELLE End of Induction Analysis.在既往未经治疗的滤泡性淋巴瘤患者中,奥滨尤妥珠单抗可作为90分钟短疗程输注给药:GAZELLE诱导期结束分析
Hemasphere. 2023 Mar 30;7(4):e860. doi: 10.1097/HS9.0000000000000860. eCollection 2023 Apr.
4
T-Cell Lymphomas, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.T 细胞淋巴瘤,2.2022 年版,NCCN 肿瘤学临床实践指南。
J Natl Compr Canc Netw. 2022 Mar;20(3):285-308. doi: 10.6004/jnccn.2022.0015.
5
Obinutuzumab plus CHOP is effective and has a tolerable safety profile in previously untreated, advanced diffuse large B-cell lymphoma: the phase II GATHER study.奥滨尤妥珠单抗联合 CHOP 方案治疗未经治疗的晚期弥漫性大 B 细胞淋巴瘤:Ⅱ期 GATHER 研究。
Leuk Lymphoma. 2019 Apr;60(4):894-903. doi: 10.1080/10428194.2018.1515940. Epub 2018 Oct 2.
6
Safety, tolerability and pharmacokinetics of shorter duration of infusion of obinutuzumab in Japanese patients with B-cell non-Hodgkin lymphoma: final results of the phase II GATS study.在日本 B 细胞非霍奇金淋巴瘤患者中,奥滨尤妥珠单抗较短输注时间的安全性、耐受性和药代动力学:GATS 研究的最终结果。
Jpn J Clin Oncol. 2018 Aug 1;48(8):736-742. doi: 10.1093/jjco/hyy087.
7
Infusion reactions: diagnosis, assessment, and management.输液反应:诊断、评估与管理
Clin J Oncol Nurs. 2010 Apr;14(2):E10-21. doi: 10.1188/10.CJON.E10-E21.
8
Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: association with increased infusion-related side effects and rapid blood tumor clearance.利妥昔单抗治疗伴有循环血液肿瘤细胞的血液系统恶性肿瘤患者:与输注相关副作用增加及血液肿瘤快速清除相关
J Clin Oncol. 1999 Mar;17(3):791-5. doi: 10.1200/JCO.1999.17.3.791.