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患者对生物类似药的看法:欧洲克罗恩病和溃疡性结肠炎协会的调查。

Patient Perspectives on Biosimilars: A Survey by the European Federation of Crohn's and Ulcerative Colitis Associations.

机构信息

Inserm U954 and Department of Gastroenterology, Nancy University Hospital, Université de Lorraine, Allée du Morvan, 54 511 Vandœuvre-lès-Nancy, France

European Federation of Crohn's and Ulcerative Colitis Associations, Rue Des Chartreux, 33-35 Brussels B 1000 Belgium.

出版信息

J Crohns Colitis. 2017 Jan;11(1):128-133. doi: 10.1093/ecco-jcc/jjw138. Epub 2016 Jul 31.

Abstract

BACKGROUND AND AIM

The aim of this survey was to find out the patients' perspectives concerning biosimilars.

METHODS

An online survey consisting of 14 questions was made available between November 2014 and October 2015. Only respondents who had heard of biosimilars were asked to respond the final twelve questions.

RESULTS

A total of 1181 patients responded. Of these, 38% had heard of biosimilars. The respondents worried about biosimilars' safety profile [47.0%], efficacy [40.3%], and molecular basis [35.0%]. Only 25.2% of the respondents had no concerns about biosimilars. Just over half [55.9%] of the respondents thought that the lower cost of the biosimilars should not come before their safety and efficacy. Only 12.5% of respondents felt that extrapolation made sense. The survey showed that 39.9% felt that patients should be systematically informed, and 26.7% felt that patient associations should be informed and able to give their opinions. It also revealed that 20.9% of the respondents would be against the idea of interchangeability if the patient was not aware; 65.7% of the respondents would want to know whether they were receiving the reference drug or the biosimilar, and have all necessary information in writing before the drug was administered. Only 31.0% of the respondents would be fully confident about biosimilars, even if they were prescribed and explained by the treating physician.

CONCLUSIONS

Most patients were not familiar with biosimilars, and those who were had doubts and concerns about the biosimilars' safety and efficacy. The patients wished to be informed and involved in decision-making concerning biosimilars.

摘要

背景与目的

本调查旨在了解患者对生物类似药的看法。

方法

2014 年 11 月至 2015 年 10 月期间进行了一项在线调查,共包含 14 个问题。仅在患者听说过生物类似药的情况下,才会被要求回答最后 12 个问题。

结果

共有 1181 名患者做出了回应。其中,38%的患者听说过生物类似药。受访者担心生物类似药的安全性[47.0%]、疗效[40.3%]和分子基础[35.0%]。只有 25.2%的受访者对生物类似药没有顾虑。超过一半[55.9%]的受访者认为生物类似药的低成本不应优先于其安全性和疗效。只有 12.5%的受访者认为类推有意义。调查显示,39.9%的受访者认为应系统地告知患者,26.7%的受访者认为应告知患者协会并使其能够发表意见。调查还显示,如果患者不知情,39.9%的受访者会反对可互换性的想法;65.7%的受访者希望在给药前了解他们正在使用的是参照药物还是生物类似药,并获得所有必要的书面信息。只有 31.0%的受访者即使是在主治医生开出处方并解释后,也会对生物类似药完全有信心。

结论

大多数患者对生物类似药并不熟悉,而那些熟悉的患者对生物类似药的安全性和疗效存在疑虑和担忧。患者希望在使用生物类似药方面得到告知并参与决策。

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