中国新疆地区腰椎管狭窄患者腰椎黄韧带肥厚的危险因素分析:回顾性、单中心、病例分析

Risk factors for ligamentum flavum hypertrophy in lumbar spinal stenosis patients from the Xinjiang Uygur Autonomous Region, China: protocol for a retrospective, single-center study

背景:黄韧带肥厚是引起椎管狭窄的重要原因之一,目前多数学者认为在CT、MRI上测量黄韧带厚度>4 mm即可诊断为肥厚,但对于肥厚的原因及分布特点尚无研究。有研究显示,L2/3,L3/4,L4/5和L5/S1所有节段的黄韧带厚度均与年龄呈正相关,而是否与民族、性别及肥胖等因素有关则少有研究报道。目的:回顾性分析中国新疆地区腰椎管狭窄患者腰椎黄韧带肥厚的危险因素。方法:研究为回顾性、单中心、病例分析,在中国新疆医科大学第六附属医院完成。回顾性收集2012年5月至2016年5月在新疆医科大学第六附属医院就诊的腰椎管狭窄104例患者的腰椎CT影像学资料进行数据分析。试验的主要观察指标为CT测量的不同民族、性别、身高、年龄、体质量患者的腰椎黄韧带厚度变化。次要结局指标为CT测量的不同民族、性别、身高、年龄及体质量患者的腰椎形态;民族、性别、身高、年龄及体质量与患者黄韧带厚度的相关性;影响黄韧带肥厚相关因素的多元线性回归分析结果。试验在北美临床试验注册中心作回顾性注册(NCT03057353)。研究方案已取得新疆医科大学第六附属医院伦理委员会的批准,且符合世界医学会制订的《赫尔辛基宣言》。参与者本人对试验方案和过程均知情同意,并签署知情同意书。讨论:试验拟通过CT测量新疆地区腰椎管狭窄患者腰椎黄韧带厚度,观察不同民族、性别、身高、年龄及体质量的新疆地区腰椎管狭窄症患者黄韧带厚度的变化规律,并分析导致黄韧带肥厚的危险因素,为临床预防新疆地区黄韧带肥厚所致的腰椎管狭窄提供量化参考数据。

BACKGROUND： Ligamentum flavum hypertrophy is one important cause of spinal stenosis. Ligamentum flavum thickness of more than 4 mm measured on computed tomography （CT） and magnetic resonance imaging is considered hypertrophy, but causes of hypertrophy and distribution characteristics remain poorly understood. Previous studies showed that the ligamentum flavum thickness at the segments L2/3, L3/4, L4/5 and L5/S1 was positively correlated with age.It remains unclear whether ligamentum flavum thickness is associated with nationality, sex and obesity. OBJECTIVE： To retrospectively analyze the risk factors for ligamentum flavum hypertrophy in lumbar spinal stenosis patients from the Xinjiang Uygur Autonomous Region, China.METHODS： We conducted a retrospective, single-center, case analysis at the Sixth Affiliated Hospital, Xinjiang Medical University, China. We collected lumbar CT imaging data of 104 patients diagnosed with lumbar spinal stenosis in the Sixth Affiliated Hospital, Xinjiang Medical University from May 2012 to May 2016. The primary outcome was the ligamentum flavum thickness of patients with different nationalities, sexes, heights, ages, and weights. The secondary outcomes were the morphology of lumbar vertebrae in patients with different nationalities, sexes, heights, ages, and weights; the correlation of nationality, sex, height, age, and weight with ligamentum flavum thickness; results of multiple linear regression analysis of relevant factors for ligamentum flavum hypertrophy. This trial has been registered at clinical Trials.gov （indentifier： NCT03057353）. This protocol has been approved by the Medical Ethics Committee of Xinjiang Medical University and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment will be obtained from each participant.DISCUSSION： This study will determine the variations in the ligamentum flavum thickness of lumbar spinal stenosis patients of different nationalities, sexes, heights, ages, and weights in the Xinjiang Uygur Autonomous Region by measuring the ligamentum flavum thickness using CT, and analyzing risk factors for ligamentum flavum hypertrophy; the findings will provide quantitative reference data for preventing lumbar spinal stenosis induced by ligamentum flavum hypertrophy in the Xinjiang Uygur Autonomous Region.