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研究中的同情用药。

Compassionate use in research.

作者信息

Miracle Vickie A

机构信息

Bellarmine University School of Nursing, Louisville, Kentucky 40223, USA.

出版信息

Dimens Crit Care Nurs. 2009 Mar-Apr;28(2):85-8. doi: 10.1097/DCC.0b013e318195d6d5.

DOI:10.1097/DCC.0b013e318195d6d5
PMID:19225323
Abstract

Critical care nurses may be involved in clinical trials involving medications, devices, or treatments. Occasionally, there may be a patient who does not meet the inclusion criteria for the clinical trial and has a condition that is not responding to approval therapies. In these cases, compassionate use may be necessary. This article discusses the definition of compassionate use, when it is appropriate, how to gain approval, and the nurse's role in caring for these patients.

摘要

重症监护护士可能会参与涉及药物、设备或治疗的临床试验。偶尔,可能会有患者不符合临床试验的纳入标准,且其病情对已批准的治疗方法没有反应。在这些情况下,可能需要进行同情用药。本文讨论了同情用药的定义、适用时机、如何获得批准以及护士在护理这些患者中的作用。

相似文献

1
Compassionate use in research.研究中的同情用药。
Dimens Crit Care Nurs. 2009 Mar-Apr;28(2):85-8. doi: 10.1097/DCC.0b013e318195d6d5.
2
Clinical research and the development of new devices: considerations for nurses.临床研究与新设备的开发:护士需考虑的因素
Dimens Crit Care Nurs. 2007 May-Jun;26(3):117-20. doi: 10.1097/01.DCC.0000267805.49487.33.
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A study in futility: Abigail Alliance for Better Access to Developmental Drugs will not expand access to experimental drugs for the terminally ill.一项徒劳无功的研究:阿比盖尔改善晚期药物可及性联盟不会扩大绝症患者对实验性药物的可及性。
Seton Hall Law Rev. 2009;39(2):559-603.
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Ethical issues of recruitment and enrollment of critically ill and injured patients for research.重症伤病患者招募与纳入研究的伦理问题。
AACN Adv Crit Care. 2007 Oct-Dec;18(4):352-5. doi: 10.1097/01.AACN.0000298626.30406.e1.
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The option of compassionate use in metastatic melanoma - way out of a therapeutic dilemma?
J Dtsch Dermatol Ges. 2009 Aug;7(8):671-9. doi: 10.1111/j.1610-0387.2009.07028.x.
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Innovation to research: some transitional obstacles in critical care units.从创新到研究:重症监护病房中的一些过渡障碍。
Crit Care Med. 2003 Mar;31(3 Suppl):S172-7. doi: 10.1097/01.CCM.0000054898.32355.65.
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Can single-patient investigational new drug studies hurry slow trains to the fast track?单患者研究性新药研究能否让慢车加速驶入快车道?
Drug Discov Today. 2006 Mar;11(5-6):185-6. doi: 10.1016/S1359-6446(05)03707-4.
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Issues related to children participating in clinical research.与儿童参与临床研究相关的问题。
J Pediatr Nurs. 2007 Aug;22(4):310-8. doi: 10.1016/j.pedn.2007.02.004.
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Caring for the silent patient.照顾沉默寡言的患者。
Am J Crit Care. 2002 Sep;11(5):480-1.
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Charging for investigational drugs under an investigational new drug application. Final rule.根据研究性新药申请对研究性药物收费。最终规则。
Fed Regist. 2009 Aug 13;74(155):40871-900.

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