同意胰岛细胞异种移植需要什么？：来自 1 型糖尿病患者访谈研究的见解和文献综述。
What does it take to consent to islet cell xenotransplantation?: Insights from an interview study with type 1 diabetes patients and review of the literature.
机构信息
Institute of Ethics, History and Theory of Medicine, Ludwig-Maximilians-Universität München, Munich, Germany.
University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
出版信息
BMC Med Ethics. 2021 Apr 1;22(1):37. doi: 10.1186/s12910-021-00607-5.
BACKGROUND
The transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed consent process for xenotransplantation.
METHODS
We conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis.
RESULTS
In the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control/self-determination challenges. Regarding the informed consent form, several of the participants' questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations.
CONCLUSIONS
To become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic.
背景
猪胰岛细胞移植为治疗 1 型糖尿病（T1DM）患者提供了一种新的潜在治疗方法。与其他生物医学技术相比，异种移植在其作为移植物来源的动物参与以及传染病的可能传播方面具有优势。由于这些方面对于潜在的异种移植接受者尤其重要，因此评估他们对该技术的看法很重要，特别是在异种移植知情同意过程中应满足的要求方面。
方法
我们对 7 名 T1DM 患者进行了定性访谈，以评估他们在进行异种移植前的信息需求。在访谈之前，参与者收到了一份关于猪胰岛细胞移植临床试验的模型知情同意书。使用定性内容分析对访谈进行转录和分析。
结果
在访谈中，我们确定了 T1DM 患者考虑异种移植作为潜在治疗选择时至关重要的几个要求：与治疗相关的要求、专业护理和监督、成功的行为和态度管理、提高生活质量以及管理控制/自决挑战。关于知情同意书，一些参与者的问题仍然没有答案，需要更详细地解决。受访者强调了个人咨询的重要性。
结论
为了成为一种可持续的治疗选择，患者特别期望改善糖尿病控制并减轻与糖尿病相关的负担。当考虑进行猪胰岛细胞移植时，健康相关方面对糖尿病患者来说至关重要。使用猪作为器官获取来源并不被认为是有问题的。
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