Análisis del uso de fármacos fuera de indicación autorizada en hematología y oncología

IF 0.2 Q4 ONCOLOGY

Revista Colombiana de Cancerologia Pub Date : 2020-03-09 DOI:10.35509/01239015.32

María Antonia Meroño Saura, M. D. Perez, Francisco Ayala de la Peña, Taida María Rodríguez Martínez, Celia Fernández Zamora, J. L. Villar

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引用次数: 0

Abstract

Background and objective: the use of off-label drugs is the use of medications in conditions other than those included in its prescribing information. The objective of this paper is to analyze the off-label drugs applications and their results, performed by the Oncology and Hematology services in a second level hospital. Materials and methods: A retrospective observational study of all requests for "off label" drugs received by the Pharmacy Service was carried out. The drugs were classified according to economic impact, a classification according to the type of drug and the reason for the request and according to the degree of evidence. The demographic, diagnostic and treatment data of the patients were analyzed for each request. A follow-up of adverse effects, median progression-free survival and median overall survival is presented. Results: 85 treatment requests were approved. Most of the treatments were high impact, mainly aimed at rare pathologies and last treatment options. 22% of the requests had a high degree of evidence. Progression free survival (PFS) and overall survival (OS) were 6.6 (95% CI 5.2-8) and 9.7 months (95% CI 8.2-11.2). 18.7% of patients had grade 3-4 toxicity when receiving treatment. Conclusions: Despite the heterogeneity of the pathologies, and the low evidence, the results obtained in SLP and SG, together with the low toxicity, force us to continue advancing in the evaluation of this type of treatments.

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血液学和肿瘤学中使用非授权适应症药物的分析

背景和目的:说明书外药物的使用是指在处方信息以外的条件下使用药物。本文的目的是分析超说明书药物的应用和他们的结果，执行肿瘤和血液服务在二级医院。材料和方法:对药学服务收到的所有“超说明书”药品申请进行回顾性观察研究。药品按经济影响进行分类，按药品种类和请求理由进行分类，按证据程度进行分类。针对每项要求分析患者的人口学、诊断和治疗数据。对不良反应、中位无进展生存期和中位总生存期进行随访。结果:85例治疗请求获得批准。大多数治疗方法疗效高，主要针对罕见病变和最后治疗方案。22%的请求具有高度证据。无进展生存期(PFS)和总生存期(OS)分别为6.6个月(95% CI 5.2-8)和9.7个月(95% CI 8.2-11.2)。18.7%的患者在接受治疗时毒性为3-4级。结论:尽管病理异质性和证据不足，但SLP和SG所获得的结果，以及低毒性，迫使我们继续推进对这类治疗的评估。

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来源期刊

Revista Colombiana de Cancerologia ONCOLOGY-

自引率

50.00%

发文量

期刊介绍： The Revista Colombiana de Cancerología is an official publication of the Instituto Nacional de Colombia (INC). The Revista is published quarterly with the aim of broadening and disseminating knowledge in the field of oncology. The Revista publishes articles on: molecular carcinogenic mechanisms and treatment responses; cancer epidemiology; clinical features and treatment of neoplastic disease and public health campaigns to control cancer. Manuscripts which contain original material shall be accepted for possible publication. Neither the article nor any part of its contents (including statistical or graphic content) may have been published or submitted for publication in any media other than the Revista Colombiana de Cancerología. No acceptance shall be made of preliminary reports (abstracts or posters) presented at scientific meetings, neither of press releases on programmed meetings. All manuscript copies shall be placed at the disposition of the Journal Editorial Board. Under exceptional circumstances, secondary publications in Spanish or other languages may be submitted, provided they comply with certain conditions which justify said submission.