脊髓损伤临床研究的纳入标准和伦理问题

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

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。

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.