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影响异种移植临床试验态度的因素:焦点小组研究报告。

Factors influencing attitudes toward xenotransplantation clinical trials: A report of focus group studies.

机构信息

Medical Professionalism, Department of Family Medicine, Rowan University School of Osteopathic Medicine, Stratford, NJ, USA.

Department of Epidemiology and Surgery, The University of Alabama at Birmingham, Birmingham, AL, USA.

出版信息

Xenotransplantation. 2021 Jul;28(4):e12684. doi: 10.1111/xen.12684. Epub 2021 Mar 7.

Abstract

BACKGROUND

Clinical trials of xenotransplantation (XTx, ie, cross-species transplantation, specifically the transplantation of genetically engineered pig organs into human recipients) are due to start within a few years.

METHODS

Five focus groups were conducted in April-May 2019, among local religious leaders (N = 10), organ procurement staff/administrators (N = 5), patients and parents of patients who may need an organ transplant or are transplant recipients (N = 9), and local businesspersons in the community (N = 3). Groups were audio-recorded, transcribed, and analyzed with NVivo software to identify themes of participants' thoughts to XTx.

RESULTS

An overall Cohen's kappa statistic of 0.71 was established. In general, there was wide agreement among participants that XTx is an exciting and acceptable option to explore as an organ alternative. Concerns were expressed primarily regarding issues of animal ethics, stigma regarding how pigs are viewed in society, organ allocation logistics, quality of life after receiving a xenograft, and how XTx would be accepted by certain theological traditions.

CONCLUSION

Overall, various stakeholders accepted XTx as a clinical option. However, there were ethical, social, and physical concerns raised. Future studies exploring the development of education strategies that may help alleviate concerns related to XTx before it becomes a clinical alternative are needed among the general public, potential XTx candidates, and their family members.

摘要

背景

异种移植(XTx,即跨物种移植,特别是将经过基因工程改造的猪器官移植到人类受体)的临床试验将在未来几年内开始。

方法

2019 年 4 月至 5 月期间,我们进行了五组焦点小组讨论,参与者包括当地宗教领袖(N=10)、器官获取工作人员/管理人员(N=5)、可能需要器官移植或已接受器官移植的患者及其家长(N=9),以及当地社区的商人(N=3)。对小组讨论进行了录音、转录,并使用 NVivo 软件进行了分析,以确定参与者对 XTx 的想法的主题。

结果

总体 Cohen's kappa 统计量为 0.71。总体而言,参与者普遍认为 XTx 是一种令人兴奋且可接受的探索器官替代物的选择。主要关注的问题是动物伦理、猪在社会中的看法所带来的耻辱感、器官分配物流、接受异种移植物后的生活质量,以及某些神学传统如何接受 XTx。

结论

总体而言,各种利益相关者都接受 XTx 作为一种临床选择。然而,也提出了一些伦理、社会和实际问题。需要在公众、潜在的 XTx 候选人和他们的家属中开展研究,探索制定教育策略,以帮助减轻在 XTx 成为临床替代方案之前与 XTx 相关的担忧。

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