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皮下给药与姑息治疗中的超说明书用药:范围综述。

Subcutaneous Drugs and Off-label Use in Hospice and Palliative Care: A Scoping Review.

机构信息

Clinical Pharmacology and Toxicology (U.W., C.M.M.), Inselspital Bern, Switzerland; Graduate School for Health Sciences (U.W.), University of Bern, Switzerland.

Institute of Primary Health Care BIHAM (F.D., C.M.M.), University of Bern, Switzerland.

出版信息

J Pain Symptom Manage. 2022 Nov;64(5):e250-e259. doi: 10.1016/j.jpainsymman.2022.07.006. Epub 2022 Jul 20.

DOI:10.1016/j.jpainsymman.2022.07.006
PMID:35870656
Abstract

BACKGROUND

Subcutaneous drug administration is an interesting approach for symptom control in hospice and palliative care. However, most drugs have no marketing authorization for subcutaneous administration and are therefore used off-label. In order to meet the requirements of a safe and effective drug therapy, especially in highly vulnerable patients, it is essential to investigate the scope of evidence of these common practices.

OBJECTIVES

The purpose of this scoping review was to provide an overview of available data on the tolerability and/or effectiveness of subcutaneously administered and off-label used drugs.

METHOD

We performed a scoping review according to the PRISMA extension to identify data available on the tolerability and/or effectiveness of 17 predefined drugs that are commonly administered subcutaneously in Swiss hospices and hospice-like institutions and that have no marketing authorization (off-label use).

RESULTS

The scoping review identified 57 studies with most data available on their tolerability (68% local, 54% systemic), clinical effects (82%), details on dosage (96%) and routes of application (100%). Information on pharmacokinetic properties was mostly missing and only available for fentanyl, levetiracetam, midazolam, and ondansetron. For seven drugs, less than five articles were identified and no studies on codeine or clonazepam were available.

CONCLUSION

This work provides an overview of current evidence on subcutaneous and off-label used drugs in hospice and palliative care. Although both are common practices, evidence on tolerability and effectiveness, particularly pharmacokinetic data, is limited and the identified information gaps need to be closed. This work establishes a basis for further research in this area.

摘要

背景

皮下给药是缓和医疗和姑息治疗中控制症状的一种有趣方法。然而,大多数药物都没有皮下给药的营销授权,因此是被超说明书使用的。为了满足安全有效的药物治疗的要求,尤其是在高度脆弱的患者中,调查这些常见做法的证据范围至关重要。

目的

本次范围综述的目的是提供关于皮下给药和超说明书使用的 17 种常见药物的耐受性和/或有效性的现有数据概述。

方法

我们根据 PRISMA 扩展进行了范围综述,以确定在瑞士收容所和类似收容所机构中常见的 17 种皮下给药且无营销授权(超说明书使用)的药物的耐受性和/或有效性的可用数据。

结果

本次范围综述确定了 57 项研究,其中大多数研究提供了关于其耐受性(68%局部,54%全身)、临床效果(82%)、剂量细节(96%)和应用途径(100%)的信息。关于药代动力学特性的信息大多缺失,只有芬太尼、左乙拉西坦、咪达唑仑和昂丹司琼有相关信息。有七种药物的研究少于五项,没有关于可待因或氯硝西泮的研究。

结论

这项工作提供了关于缓和医疗和姑息治疗中皮下给药和超说明书使用药物的当前证据概述。尽管两者都是常见做法,但关于耐受性和有效性的证据,特别是药代动力学数据,是有限的,需要填补已确定的信息空白。这项工作为该领域的进一步研究奠定了基础。

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