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多发性硬化症患者的家庭纳武单抗输注:一项先导随机交叉试验。

Home infusions of natalizumab for people with multiple sclerosis: a pilot randomised crossover trial.

机构信息

Adelaide Nursing School, University of Adelaide, Adelaide, South Australia, Australia.

Post Op Care at Home (Pty Ltd), Adelaide, South Australia, Australia.

出版信息

Ann Clin Transl Neurol. 2021 Aug;8(8):1610-1621. doi: 10.1002/acn3.51410. Epub 2021 Jul 21.

DOI:10.1002/acn3.51410
PMID:34288591
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8351394/
Abstract

OBJECTIVE

The delivery of healthcare at home has expanded to intravenous infusions of monoclonal antibodies. A recently developed model of care for home infusions of natalizumab for people with relapsing-remitting multiple sclerosis was evaluated. This pilot study of home infusions of natalizumab and usual care (attendance in a hospital out-patients' clinic) compared safety, feasibility, patient satisfaction, effectiveness and costs.

METHODS

In this randomised AB/BA crossover trial, 37 adults were randomised to usual care (n = 19) or home infusions (n = 18). After three infusions, patients crossed over to the alternate treatment for another three infusions. Patient safety outcomes and adherence, satisfaction, quality of life, disability and costs were compared.

RESULTS

No adverse events were recorded from 207 infusions from 35 patients across both home and clinic infusions. There was no difference in adherence (p = 0.71) and infection rates (p = 0.84) between home and clinic settings. Satisfaction with "convenience" of home infusions was significantly greater (p = 0.008) but there were no differences in quality of life measures. Excluding pharmacy, costs were A$74 lower per infusion at home, including A$16 of patients" out-of-pocket costs.

INTERPRETATION

There were no differences in safety and effectiveness between clinic and home infusions of natalizumab. The home infusions were shown to be feasible, more convenient and less expensive than usual care. Larger scale studies are required to verify these preliminary findings, particularly around safety and management of hypersensitivity adverse events in the home setting and for equivalence of clinical outcomes.

摘要

目的

家庭医疗服务已经扩展到静脉输注单克隆抗体。评估了一种新开发的用于在家中输注那他珠单抗治疗复发缓解型多发性硬化症的护理模式。这项关于在家中输注那他珠单抗和常规护理(在医院门诊就诊)的试点研究比较了安全性、可行性、患者满意度、有效性和成本。

方法

在这项随机 AB/BA 交叉试验中,37 名成年人被随机分配到常规护理组(n=19)或家庭输注组(n=18)。在进行了三次输注后,患者交叉到另一种治疗方案,再进行三次输注。比较了患者安全性结局和依从性、满意度、生活质量、残疾和成本。

结果

在 35 名患者的 207 次输注中,无论是家庭输注还是门诊输注,均未记录到不良事件。家庭和门诊环境下的依从性(p=0.71)和感染率(p=0.84)没有差异。家庭输注的“便利性”满意度显著更高(p=0.008),但生活质量测量指标没有差异。不包括药房费用,家庭输注每次的费用比门诊输注低 74 澳元,包括患者自付费用 16 澳元。

解释

在家中输注和门诊输注那他珠单抗在安全性和有效性方面没有差异。家庭输注被证明是可行的、更方便且比常规护理更便宜。需要更大规模的研究来验证这些初步发现,特别是在家庭环境下安全性和过敏反应不良事件管理方面,以及临床结果的等效性方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/5cba35291c18/ACN3-8-1610-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/22959d4d530b/ACN3-8-1610-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/1f5b54da641f/ACN3-8-1610-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/5cba35291c18/ACN3-8-1610-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/22959d4d530b/ACN3-8-1610-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/1f5b54da641f/ACN3-8-1610-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/70d5/8351394/5cba35291c18/ACN3-8-1610-g001.jpg

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本文引用的文献

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World J Gastroenterol. 2020 Sep 28;26(36):5437-5449. doi: 10.3748/wjg.v26.i36.5437.
2
Personalized extended interval dosing of natalizumab in MS: A prospective multicenter trial.多发性硬化症中个性化延长纳武单抗给药间隔:一项前瞻性多中心试验。
Neurology. 2020 Aug 11;95(6):e745-e754. doi: 10.1212/WNL.0000000000009995. Epub 2020 Jul 20.
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AAPS Open. 2023;9(1):3. doi: 10.1186/s41120-022-00069-y. Epub 2023 Jan 23.
Developing a Model of Care for Home Infusions of Natalizumab for People With Multiple Sclerosis.
为多发性硬化症患者开发那他珠单抗家庭输注护理模式。
J Infus Nurs. 2019 Nov/Dec;42(6):289-296. doi: 10.1097/NAN.0000000000000343.
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Infection Risks Among Patients With Multiple Sclerosis Treated With Fingolimod, Natalizumab, Rituximab, and Injectable Therapies.多发性硬化症患者接受芬戈莫德、那他珠单抗、利妥昔单抗和注射治疗的感染风险。
JAMA Neurol. 2020 Feb 1;77(2):184-191. doi: 10.1001/jamaneurol.2019.3365.
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Systematic patient involvement for homebased outpatient administration of complex chemotherapy in acute leukemia and lymphoma.系统的患者参与,用于急性白血病和淋巴瘤的家庭门诊复杂化疗管理。
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