腰椎Active-L人工椎间盘置换术与腰椎融合术的临床比较研究

背景：腰椎融合术一直被广大学者认为是治疗腰椎间盘退行性病变的“金标准”，但文献报道腰椎融合术加速相邻节段退变的发生，为保留脊柱功能单位的生理和运动特性，提出人工椎间盘置换术。目的：比较前路Active．L型人工椎间盘假体置换术和后路腰椎融合术治疗单节段腰椎间盘退行性病变患者的疗效和安全性。方法：2009年1月至2010年4月62例因腰椎间盘退行性病变的手术患者，根据手术方式分为试验组和对照组。试验组行腰椎人工椎间盘置换术患者20例，男10例，女10例；年龄36-58岁，平均47．7岁；术前诊断：腰椎间盘突出症16例，腰椎间盘源性下腰痛4例，腰椎间盘后路开窗术后复发1例；手术节段：13-42例，L4-513例，L5-S15例。对照组行腰椎融合术患者42例，男22例，女20例；年龄40-60岁，平均48．5岁；术前诊断：腰椎间盘突出症32例，腰椎间盘源性下腰痛7例，腰椎间盘后路开窗术后复发3例；手术节段：13-44例，L4-526例，15-S112例。随访观察指标包括：（1）临床疗效评定：术后疼痛及功能改善率的评定；手术成功率的评定。（2）影像学评定：腰椎前凸角和手术节段的椎问活动度独立因素t检验进行对比评价。结果：全部获得随访，试验组随访时间为12-27个月，平均19．3个月；对照组随访时间为12-27个月，平均19．8个月。两组患者在治疗下腰痛方面均取得明显疗效。在改善ODI功能评分、VAS疼痛评分、SF-36、椎间隙活动度上，试验组优于对照组，两组间比较有显著性差异（P〈0．05）；在恢复腰椎前凸序列上，两组间无显著性差异（P〉0．05）；两组均未出现严重并发症。结论：人工椎间盘置换术和融合术均取得良好的临床效果，但人工椎间盘置换术在掌握严格的手术适应证和禁忌证的条件下，相比腰椎融合术具有更好的临床疗效并保留病变节段的活动度。因此，在合适的手术适应证下，人工间盘置换术是一种更优且可以替代腰椎融合术的有效治疗方法。

Clinical outcomes of total lumbar disc replacement with Active-L versus lumbar fusion

Background:Lumbar fusion has been recognised as the "gold standard" to treat degenerative disc disease,but some literatures have reported that lumbar fusion can accelerate the adjacent segment degeneration.For retaining physiological and motion characteristics of the spinal functional unit,artificial intervertebral disc replacement has been proposed.Objective:The purpose of the present study is to compare the efficacy and safety between lumbar disc replacement with Active-L artificial disc and posterior lumbar interbody fusion for single-level degenerative disease.Methods:From January 2009 to April 2010,62 patients with degenerative diseases of lumbar dics were treated by total lumbar disc replacement with the Active-L artificial disc(investigational group) or lumbar fusion(control group).In the investigational group,there were 10 males and 10 females with a mean age of 47.7 years(range 36-58).Of them,16 patients were diagnosed as lumbar intervertebral disc protrusion,4 patients had low back pain and one had posterior operation history;2 patients were treated at L3-4,13 at L4-5 and 5 at L5-S1.In the control group,there were 22 males and 20 females with a mean age of 48.5 years(range 40-60).Of them,32 patients were diagnosed as lumbar intervertebral disc protrusion,7 had low back pain and 3 had posterior operation history;4 patients were treated at L3-4,26 at L4-5 and 12 at L5-S1.Visual analog scale(VAS) and Oswestry disability index(ODI) were used to assess back pain and functional improvement.X-ray was used to measure the angle of lumbar lordosis and range of motion.Results:Overall clinical success was achieved in all patients.The average follow-up duration was 19.3 months(range 12-27) in investigational group and 19.8 months(range 12-27) in control group.Patients in the investigational group had statistically lower pain and ODI scores(P<0.05),compared with the control group.No severe complication occurred in the two groups.Conclusions:With the control of indication and contraindication,lumbar total disc replacement with Active-L artificial disc is more effective than posterior lumbar interbody fusion for the lumbar degenerative diseases.