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克服输血检测中的药物干扰:聚焦达雷妥尤单抗

Overcoming Drug Interference in Transfusion Testing: A Spotlight on Daratumumab.

作者信息

Nedumcheril Marilyn T, DeSimone Robert A, Racine-Brzostek Sabrina E, Chaekal Ok Kyong, Vasovic Ljiljana V

机构信息

Department of Pathology and Laboratory Medicine, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA.

New York Blood Center Enterprises, New York, NY, USA.

出版信息

J Blood Med. 2021 May 25;12:327-336. doi: 10.2147/JBM.S213510. eCollection 2021.

DOI:10.2147/JBM.S213510
PMID:34079412
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8164699/
Abstract

Daratumumab, a monoclonal antibody therapeutic, is highly efficacious and widely used in all stages of multiple myeloma and amyloidosis and has promising activity in other hematologic disorders. Daratumumab interacts with red blood cells, interfering with pre-transfusion testing. This interference can lead to compromising transfusion safety, extensive blood bank work ups and delays in provision of compatible units. Several methods have been developed to negate daratumumab interference with indirect antiglobulin testing. They are based on i) standard blood bank techniques including dithiothreitol and enzymatic treatment of reagent cells, using reagent red blood cells negative for CD38, ii) blocking CD38 antigens on reagent or donor cells, iii) neutralization of anti-CD38 antibody in patient plasma prior to testing, and iv) extended antigen typing of patient red blood cells in conjunction with provision of phenotypically matched units for transfusion. Implementation of those methods by the blood bank should be a planned effort coordinated with the patient's clinical team. Timely involvement of blood bank and transfusion services and educational efforts by both blood banks and clinical providers can improve the overall daratumumab safety profile in regard to blood transfusion.

摘要

达雷妥尤单抗是一种单克隆抗体疗法,具有高效性,广泛应用于多发性骨髓瘤和淀粉样变性的各个阶段,并且在其他血液系统疾病中也具有良好的活性。达雷妥尤单抗与红细胞相互作用,干扰输血前检测。这种干扰可能会危及输血安全,导致血库进行大量检查,并延误提供相容的血液单位。已经开发出几种方法来消除达雷妥尤单抗对间接抗球蛋白试验的干扰。这些方法基于:i)标准血库技术,包括使用对CD38呈阴性的试剂红细胞进行二硫苏糖醇和酶处理试剂细胞;ii)封闭试剂或供体细胞上的CD38抗原;iii)在检测前中和患者血浆中的抗CD38抗体;iv)对患者红细胞进行扩展抗原分型,并提供表型匹配的血液单位进行输血。血库实施这些方法应该是与患者临床团队协调的有计划的工作。血库和输血服务部门的及时参与以及血库和临床提供者的教育工作可以改善达雷妥尤单抗在输血方面的整体安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8539/8164699/1fbd558b1e2f/JBM-12-327-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8539/8164699/f43174aacda2/JBM-12-327-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8539/8164699/1fbd558b1e2f/JBM-12-327-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8539/8164699/f43174aacda2/JBM-12-327-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8539/8164699/1fbd558b1e2f/JBM-12-327-g0002.jpg

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本文引用的文献

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Personalized immunoglobulin aptamers for detection of multiple myeloma minimal residual disease in serum.用于检测血清中多发性骨髓瘤微小残留病的个体化免疫球蛋白适体。
Commun Biol. 2020 Dec 17;3(1):781. doi: 10.1038/s42003-020-01515-x.
2
Daratumumab interference in flow cytometric anti-granulocyte antibody testing can be overcome using non-human blocking antibodies.达雷妥尤单抗对流式细胞术抗粒细胞抗体检测的干扰可以使用非人类阻断抗体来克服。
Vox Sang. 2021 Jan;116(1):116-122. doi: 10.1111/vox.12989. Epub 2020 Aug 14.
3
Daudi cell stroma: An alternative to dithiothreitol to resolve daratumumab interference in pretransfusion testing.
达妥木单抗干扰输血前检测时,使用达乌迪细胞基质替代二硫苏糖醇进行处理。
Transfusion. 2020 Sep;60(9):2090-2096. doi: 10.1111/trf.15932. Epub 2020 Jul 6.
4
Risk of RBC alloimmunization in multiple myeloma patients treated by Daratumumab.达雷妥尤单抗治疗多发性骨髓瘤患者的 RBC 同种免疫风险。
Vox Sang. 2020 Feb;115(2):207-212. doi: 10.1111/vox.12864. Epub 2019 Nov 14.
5
Will Daratumumab be the next game changer in early thymic precursor-acute lymphoblastic leukaemia?达雷妥尤单抗会成为早期胸腺祖细胞急性淋巴细胞白血病治疗的下一个变革者吗?
Br J Haematol. 2019 Oct;187(2):e33-e35. doi: 10.1111/bjh.16154. Epub 2019 Aug 26.
6
Manual polybrene method for pretransfusion test could overcome the interference of daratumumab therapy in myeloma.输血前检测的手工聚凝胺法可克服达雷妥尤单抗治疗对骨髓瘤的干扰。
Transfusion. 2019 Aug;59(8):2751-2752. doi: 10.1111/trf.15341.
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Daratumumab displays in vitro and in vivo anti-tumor activity in models of B-cell non-Hodgkin lymphoma and improves responses to standard chemo-immunotherapy regimens.达雷木单抗在 B 细胞非霍奇金淋巴瘤模型中表现出体外和体内的抗肿瘤活性,并改善了对标准化疗免疫治疗方案的反应。
Haematologica. 2020 Apr;105(4):1032-1041. doi: 10.3324/haematol.2018.211904. Epub 2019 Jul 11.
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Additional validation of Osaka method (0.01 mol/L dithiothreitol) for negating the daratumumab interference.大阪方法(0.01mol/L二硫苏糖醇)用于消除达雷妥尤单抗干扰的额外验证。
Transfusion. 2019 Jul;59(7):2479-2480. doi: 10.1111/trf.15305.
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Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma.达雷妥尤单抗用于复发/难治性套细胞淋巴瘤、弥漫性大B细胞淋巴瘤和滤泡性淋巴瘤的2期研究。
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A blockage monoclonal antibody protocol as an alternative strategy to avoid anti-CD38 interference in immunohematological testing.一种针对单克隆抗体的阻断方案,作为避免免疫血液学检测中抗 CD38 干扰的替代策略。
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