《中国康复理论与实践》

《中国康复理论与实践》

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脊髓损伤临床研究的纳入标准和伦理问题①

王玉明1，宫慧明1，武永刚2，马科1，李建军1   

  1. 1.中国康复研究中心北京博爱医院脊柱脊髓神经功能重建科，北京市100068；2.内蒙古巴彦淖尔市医院，内蒙古巴彦淖尔市015000。
  • 出版日期:2016-02-25 发布日期:2016-06-01

Criteria and Ethical Issues for Clinical Research of Spinal Cord Injury (review)

WANG Yu-ming1, GONG Hui-ming1, WU Yong-gang2, MA Ke1, LI Jian-jun1   

  1. 1. Department of Spinal and Neural Functional Reconstruction, Beijing Bo'ai Hospital, China Rehabilitation Research Center, Beijing 100068, China; 2. Bayannur Hospital, Bayannur, Inner Mongolia 015000, China
  • Published:2016-02-25 Online:2016-06-01

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摘要： 脊髓损伤的预后涉及多种因素，尚存在损伤机制、严重程度及个体差异大的特点，因此，规范的临床试验对于研究结果的可靠性具有至关重要的影响，故需要高度重视患者的入选、排除标准和相关伦理学问题，以及治疗标准化、知情同意等问题。本文分别叙述这些因素对脊髓损伤临床研究的影响。脊髓损伤临床研究应根据具体研究内容制定纳入及排除标准，并控制其一致性；知情同意对于临床研究是必要的，尤其是不确定效益和有风险的临床试验；还需规范化手术操作及标准化康复治疗。

关键词: 脊髓损伤, 临床试验, 入选标准, 伦理, 综述

Abstract: The outcome of spinal cord injury is related to many factors, such as mechanism and severity of injury, and differences of individual. The standard of clinical trial plays a very important role in the reliability of the research. especially the inclusion and exclusion criterias, ethical issues, treatment standardization, informed consent and other issues. The effect of these factors on the clinical trial of spinal cord injury was summarized in this article. The inclusion and exclusion criterias to control the consistency should be developed based on the specific research content. Informed consent for clinical trial is also necessary, especially to the clinical trials with uncertainly benefits and risks, as well as the standardization of the operation procedures and rehabilitation treatment.

Key words: spinal cord injury, clinical trial, inclusion criteria, ethics, review