摘要
背景:胆囊收缩素作为一种内源性的神经保护因子,在神经系统中的作用越来越引起人们的重视。前期动物实验发现胆囊收缩素能有效促进周围神经损伤再生,在此基础上进一步进行临床试验,观察局部应用胆囊收缩素处理神经吻合口能否促进周围神经再生。方法/设计:前瞻性随机对照试验。招募腓总神经完全断裂患者100例,随机分为2组,均行神经缝合后局部明胶海绵浸润不同药物包绕吻合处,试验组药物为8 nmol/kg胆囊收缩素,对照组为生理盐水。治疗后6,12,24周随访,检测腓总神经传导速度和肌电图、神经纤维形态,末次随访评估临床疗效,并记录患者随访期间所有的不良事件,评估治疗的有效性和安全性。讨论:基于临床应用的思路,将胆囊收缩素作为神经生长因子合成诱导剂加以观察性研究,以期为寻找周围神经治疗药物提供一个新思路。伦理批准:试验方案已经莆田学院附属医院医学伦理委员会批准,批件文号:2014116。受试者对试验方案知情同意,接受治疗前签署"知情同意书"。
BACKGROUND： Cholecystokinin as an endogenous neuroprotective factor in the nervous system has garnered increasing attention. Findings from previous animal studies show that cholecystokinin can effectively promote the regeneration of the injured peripheral nerve. On this basis, further clinical trials will be performed to observe whether local application of cholecystokinin at nerve anastomosis can promote peripheral nerve regeneration.METHODS/DESIGN： As a prospective randomized controlled trial, this study will enroll 100 patients with complete rupture of the peroneal nerve, who will be randomly divided into two groups： after nerve suture and partial gelatin sponge infiltration at nerve anastomosis, the patients will be treated with 8 nmol/kg cholecystokinin（treatment group） or saline（control group）. At 6, 12, 24 weeks after treatment, common peroneal nerve conduction velocity and electromyography and nerve fiber morphology will be detected; the clinical efficacy at the last follow-up will be assessed; and all adverse events during the follow-up will be recorded to assess the therapeutic efficacy and safety. DISCUSSION： In this study, cholecystokinin as an inducing agent for nerve growth factor synthesis will be observed and studied, with a view to providing a new idea for seeking peripheral nerve therapy. ETHICAL APPROVAL： The study protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Putian University（approval No. 2014116）. Written informed consent will be obtained from patients before treatment.
出处
《中国组织工程研究》
CAS
北大核心
2016年第11期1623-1629,共7页
Chinese Journal of Tissue Engineering Research
基金
福建省莆田市科技局医学科技课题计划(2012S03(4))~~
