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使用含有生物材料的产品(皮肤替代品)和敷料时,应获得患者的知情同意。

Informed consent should be obtained from patients to use products (skin substitutes) and dressings containing biological material.

作者信息

Enoch S, Shaaban H, Dunn K W

机构信息

Department of Plastic Surgery, University Hospitals of South Manchester, UK.

出版信息

J Med Ethics. 2005 Jan;31(1):2-6. doi: 10.1136/jme.2003.005272.

Abstract

BACKGROUND

Biological products (tissue engineered skin, allograft and xenograft, and biological dressings) are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature.

AIMS

This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents.

METHODS

The religious groups that make up about 75% of the United Kingdom population were identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products (11 biological and 6 synthetic dressings) was sent to 100 healthcare professionals working in seven specialist units in the UK.

RESULTS

All religious leaders (100% response rate) replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals (73% response rate) surveyed knew the constituents of all the products correctly.

CONCLUSION

Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients.

摘要

背景

生物制品(组织工程皮肤、同种异体移植物和异种移植物以及生物敷料)广泛应用于烧伤、慢性伤口及其他急性损伤的治疗。然而,其使用引发的宗教和伦理问题,包括同意问题,在医学文献中从未得到探讨。

目的

本研究旨在确定宗教领袖对生物制品可接受性的看法,并评估医疗保健专业人员对其成分的知晓情况。

方法

确定了占英国人口约75%的宗教团体,并向其领袖发送了一份关于11种生物制品的问卷。另一份关于17种产品(11种生物制品和6种合成敷料)的问卷被发送给在英国七个专科单位工作的100名医疗保健专业人员。

结果

所有宗教领袖(回复率100%)均作了回复,有些是在咨询国际机构后回复的。其中,77%的人表示应告知患者生物制品的成分并获得同意。一些领袖对特定产品表示担忧,包括病毒和朊病毒疾病的传播、对动物的残忍行为以及源自新生儿的材料。接受调查的医疗保健专业人员中(回复率73%),没有人能正确知晓所有产品的成分。

结论

在生物制品使用中忽视宗教敏感性和同意问题可能会产生非常严重的后果,包括诉讼。医院和制造商应立即采取措施,让医疗保健专业人员了解这些产品的成分,以便他们能够获得患者的知情同意。

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本文引用的文献

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Prion diseases.朊病毒疾病
J Neurovirol. 2003 Apr;9(2):183-93. doi: 10.1080/13550280390194082.
2
Deaths from variant Creutzfeldt-Jakob disease in the UK.英国变异型克雅氏病死亡病例
Lancet. 2003 Mar 1;361(9359):751-2. doi: 10.1016/s0140-6736(03)12632-3.
4
Clinical evaluation of skin substitutes.皮肤替代物的临床评估。
Burns. 2001 Aug;27(5):545-51. doi: 10.1016/s0305-4179(01)00020-1.
7
Ethical issues in burn care.烧伤护理中的伦理问题。
Burns. 1999 Jun;25(4):307-15. doi: 10.1016/s0305-4179(98)00151-x.
8
Skin substitutes in burns.烧伤中的皮肤替代物。
Burns. 1999 Mar;25(2):97-103. doi: 10.1016/s0305-4179(98)00176-4.
10
Skin replacements.皮肤替代物
Clin Plast Surg. 1998 Jul;25(3):407-23.

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