脊柱外科杂志  2024, Vol.22 Issue(4): 239-245   PDF    
内窥镜下腰椎椎间融合术与微创经椎间孔入路腰椎椎间融合术治疗退行性腰椎椎管狭窄症的疗效及安全性对比
张青山, 张亚宁, 常建军     
临汾市人民医院骨科, 临汾 041000
摘要: 目的 探讨脊柱内窥镜下腰椎椎间融合术(Endo-LIF)与微创经椎间孔入路腰椎椎间融合术(MIS-TLIF)治疗退行性腰椎椎管狭窄症(DLSS)的疗效与安全性。方法 回顾性分析2020年7月—2022年12月收治的114例DLSS患者临床资料,根据手术方式分为Endo-LIF组和MIS-TLIF组,采用倾向性评分进行1∶1匹配,剔除不匹配的患者,每组53例。记录并比较2组手术时间、术中出血量、术后引流量、术后下床时间、住院时间、融合情况及并发症发生情况。于术前和术后1 d、3 d检测肾上腺素E、皮质醇、C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)水平等创伤应激指标。于术前、术后7 d、术后3个月采用疼痛视觉模拟量表(VAS)评分评估腰痛及下肢痛程度,采用Oswestry功能障碍指数(ODI)和日本骨科学会(JOA)评分评估腰椎功能;在全脊柱X线片上测量椎间隙高度、腰椎前凸角、硬膜囊横截面积、椎间孔面积。结果 所有手术顺利完成,患者随访12个月。Endo-LIF组术中出血量、术后引流量少于MIS-TLIF组,手术时间、术后下床时间、住院时间短于MIS-TLIF组,差异均有统计学意义(P < 0.05)。2组术后1 d、3 d血清前列腺素E、皮质醇、CRP、TNF-α水平较术前升高,且Endo-LIF组术后1 d、3 d各创伤应激指标水平低于MIS-TLIF组,差异均有统计学意义(P < 0.05)。2组术后7 d、术后3个月的腰痛和下肢痛VAS评分、ODI、JOA评分较术前明显改善,且Endo-LIF组较MIS-TLIF组改善更明显,差异均有统计学意义(P < 0.05)。2组术后7 d、术后3个月椎间隙高度、腰椎前凸角、硬膜囊横截面积、椎间孔面积较术前改善,差异均有统计学意义(P < 0.05);组间差异均无统计学意义(P > 0.05)。Endo-LIF组并发症发生率低于MIS-TLIF组,差异有统计学意义(P < 0.05)。2组术后均100%融合。结论 与MIS-TLIF相比,Endo-LIF治疗DLSS能缩短手术时间,减少术中出血量和术后引流量,加速康复进程,减轻创伤应激及疼痛程度,促进腰椎功能恢复,且并发症发生率较低,具有明显优势,值得临床推广。
关键词: 腰椎    椎管狭窄    脊柱融合术    外科手术,微创性    
Comparison in efficacy and safety between endoscopic lumbar interbody fusion and minimally invasive transforaminal lumbar interbody fusion in treatment of degenerative lumbar spinal stenosis
Zhang Qingshan, Zhang Yaning, Chang Jianjun     
Department of Orthopaedics, Linfen People's Hospital, Linfen 041000, Shanxi, China
Abstract: Objective To evaluate the efficacy and safety of endoscopic lumbar interbody fusion(Endo-LIF) and minimally invasive transforaminal lumbar interbody fusion(MIS-TLIF) in the treatment of degenerative lumbar spinal stenosis(DLSS). Methods A total of 114 patients with DLSS from July 2020 to December 2022 were retrospectively analyzed and divided into Endo-LIF group and MIS-TLIF group according to surgical methods using propensity score for 1∶1 matching, excluding mismatched patients, with 53 patients in each group. The operation time, intraoperative blood loss, postoperative drainage volume, postoperative time getting out of bed, hospital stay, fusion and complications of the 2 groups were recorded and compared. The levels of epinephrine E, cortisol, C-reactive protein(CRP), tumor necrosis factor-α(TNF-α) were detected before and 1 d and 3 d after surgery. The visual analogue scale(VAS) score was used to evaluate the intensity of low back pain and leg pain before and 7 d, 3 months after surgery. The Oswestry disability index(ODI) and Japanese Orthopaedic Association(JOA) score were used to evaluate the lumbar function. The intervertebral height, lumbar lordosis angle, dural sac cross-sectional area and foramen area were measured on whole spine roentgenograph. Results All the operations were successfully completed and the patients were followed up for 12 months. The intraoperative blood loss and postoperative drainage volume in Endo-LIF group were lower than those in MIS-TLIF group, and the operation time, postoperative time getting out of bed and hospital stay were shorter than those in MIS-TLIF group, all with a statistical significance(P < 0.05). The levels of prostaglandin E, cortisol, CRP and TNF-α in the 2 groups at postoperative 1 and 3 d were higher than those before surgery, and the above traumatic stress indexes at postoperative 1 and 3 d in Endo-LIF group were lower than those in MIS-TLIF group, all with a statistical significance(P < 0.05). The VAS score of lower back pain and leg pain, ODI and JOA score in the 2 groups at postoperative 7 d and 3 months were significantly improved compared with those before surgery, and the improvements in Endo-LIF group were more obvious than those in MIS-TLIF group, all with a statistical significance(P < 0.05). The intervertebral height, lumbar lordosis angle, dural sac cross-sectional area and foraminal area in the 2 groups at postoperative 7 d and 3 months were improved compared with those before surgery, all with a statistical significance(P < 0.05). However, there was no statistical significance in the above indexes between the 2 groups(P > 0.05). The incidence of complications in Endo-LIF group was lower than that in MIS-TLIF group, and the difference was statistically significant(P < 0.05). Both groups achieved 100% fusion after surgery. Conclusion Compared with MIS-TLIF, Endo-LIF in the treatment of DLSS can shorten the operation time, reduce the amount of intraoperative blood loss and postoperative drainage volume, accelerate the rehabilitation process, reduce the intensity of traumatic stress and pain, promote the recovery of lumbar function, and with a lower incidence of complications, thus having obvious advantages and being worthy of clinical promotion.
Key words: Lumbar vertebrae    Spinal stenosis    Spine fusion    Surgical procedures, minimally invasive    

退行性腰椎椎管狭窄症(DLSS)发生率居于椎管类疾病的第二位,仅次于腰椎椎间盘突出症,多见于50岁以上中老年人群,多数患者经非手术治疗无效,须手术治疗[1-2]。目前,微创经椎间孔入路腰椎椎间融合术(MIS-TLIF)是治疗DLSS的主要术式,具有操作难度低、椎体稳定性好等优点,临床认可度较高[3]。但大量临床实践证实,MIS-TLIF术中出血量较大,术后并发症发生风险较高[4-5]。随着脊柱内窥镜技术的不断发展,内窥镜下腰椎椎间融合术(Endo-LIF)逐渐应用于腰椎疾病的治疗,并受到临床广泛关注[6]。本研究对Endo-LIF与MIS-TLIF治疗DLSS疗效与安全性进行对比分析,旨在为临床选择更安全有效的术式提供理论依据,现报告如下。

1 资料与方法 1.1 一般资料

纳入标准:①经临床症状、体格检查及影像学检查确诊为单节段DLSS;②具备手术指征;③知晓病情并签订手术知情同意书。排除标准:①合并Ⅱ度及以上腰椎滑脱;②合并骨质疏松症;③合并脊柱侧凸(Cobb角 > 20°);④合并恶性肿瘤;⑤合并其他椎管类疾病;⑥无法耐受手术。回顾性分析2020年7月—2022年12月收治的114例DLSS患者临床资料,根据手术方式分为Endo-LIF组和MIS-TLIF组,采用倾向性评分匹配(卡钳值为0.2),对2组患者进行1∶1匹配,剔除不匹配的患者后,每组纳入患者53例(表 1)。

表 1 2组一般资料 Tab. 1 General data of 2 groups
1.2 手术方法及术后处理

Endo-LIF组患者全身麻醉后取俯卧位,常规消毒、铺巾,采用C形臂X线机(型号PLX7000B,南京普爱医疗设备股份有限公司)透视确认目标椎间隙,标记上下椎弓根中心点,于棘突旁做长度为2.0 ~ 3.0 cm的切口,将直径为2.0 mm的克氏针穿入椎间盘(过程中须经过下关节突外缘及上关节突尖部小关节),经透视确认位置满意后将FX6342208O型内窥镜系统显示器(Joimax公司,德国)插入,撑开管道,连接水冲系统,于小关节突关节上采用内窥镜外环锯开窗,采用咬骨钳扩大窗口,咬除部分下关节突外缘、上关节突尖部(图 1a)、突出椎间盘、对侧黄韧带(图 1b),充分暴露出口根、走行根,在确认解剖组织关系后于椎间隙推入套管,透视满意后将自体骨粒以外倾约30°的角度植入,置入异体骨无菌融合器,经皮置入椎弓根螺钉,于内窥镜下确认融合器及椎弓根螺钉位置满意后撤出内窥镜系统,加压固定,再次确认置入物位置满意后冲洗手术操作区、止血,放置引流管,缝合切口。

图 1 2组术中内窥镜下操作 Fig. 1 Intraoperative endoscopic procedures of 2 groups a:Endo-LIF组,咬除部分下关节突外缘和上关节突尖部  b:Endo-LIF组,切除突出髓核组织  c:MIS-TLIF组,钝性分离皮下组织与肌间隙,安装Quadrant通道系统  d:MIS-TLIF组,切除增生的关节突和黄韧带后减压状态 a: Endo-LIF group, biting off outer edge of lower articular process and apex of upper articular process  b: Endo-LIF group, excision of protruding nucleus pulposus tissue  c: MIS-TLIF group, blunt separation of subcutaneous tissue and muscle space, installation of Quadrant channel system  d: MIS-TLIF group, decompression status after excision of hypertrophic articular processes and ligamentum flavum

MIS-TLIF组患者全身麻醉后取俯卧位,常规消毒、铺巾,采用C形臂X线机(型号PLX7000B,南京普爱医疗设备股份有限公司)透视确认目标椎间隙,标记上下椎弓根中心点,于后正中线做一长度约3.0 cm纵向切口,选择多裂肌与最长肌间隙入路,钝性分离皮下组织与肌间隙(图 1c),充分暴露上下关节突关节,将套管和二级导棒置入,安装Quadrant通道系统,行椎间孔减压,凿除增生关节突、咬除黄韧带(图 1d),取出椎间盘髓核组织,刮除残留的软骨终板,置入填充有自体骨粒的椎间融合器,经皮置入椎弓根螺钉连接预弯的钛棒并加压固定,撤出操作装置,透视确认置入物位置满意后冲洗手术操作区、止血,放置引流管,缝合切口。

2组术后均给予抗生素预防感染,予以冷敷、甘露醇消肿等处理,根据引流量判断是否拔除引流管,术后3个月内患者佩戴支具保护腰椎。

1.3 观察指标

记录并比较2组手术时间、术中出血量、术后引流量、术后下床时间、住院时间及并发症发生情况。于术前和术后1 d、3 d检测创伤应激指标,包括肾上腺素E、皮质醇、C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)水平。于术前、术后7 d、术后3个月采用疼痛视觉模拟量表(VAS)评分[7]评估腰痛及下肢痛程度,采用Oswestry功能障碍指数(ODI)[8]和日本骨科学会(JOA)评分[9]评估腰椎功能。于术前、术后7 d、术后3个月在全脊柱X线片上测量椎间隙高度、腰椎前凸角、硬膜囊横截面积、椎间孔面积,每个指标测量3次取平均值。术后12个月X线片可见植骨椎间隙有连续骨小梁形成或手术节段活动度 < 4°判定为植骨融合。

1.4 统计学处理

采用SPSS 27.0软件对数据进行统计分析,符合正态分布的计量资料以x±s表示,组间比较采用独立样本t检验,组内各时间点数据比较采用配对样本t检验;计数资料以例数或百分比表示,采用χ2检验;以P < 0.05为差异有统计学意义。

2 结果

所有手术顺利完成,患者随访12个月,Endo-LIF组失访2例,MIS-TLIF组失访1例。Endo-LIF组术中出血量、术后引流量少于MIS-TLIF组,手术时间、术后下床时间、住院时间短于MIS-TLIF组,差异均有统计学意义(P < 0.05,表 2)。2组术后1 d、3 d血清前列腺素E、皮质醇、CRP、TNF-α水平较术前升高,且Endo-LIF组术后1 d、3 d上述创伤应激指标水平低于MIS-TLIF组,差异均有统计学意义(P < 0.05,表 2)。2组术后7 d、术后3个月腰痛和下肢痛VAS评分、ODI、JOA评分较术前明显改善,且Endo-LIF组较MIS-TLIF组改善更明显,差异均有统计学意义(P < 0.05,表 2)。2组术后7 d、术后3个月椎间隙高度、腰椎前凸角、硬膜囊横截面积、椎间孔面积较术前改善,差异均有统计学意义(P < 0.05,表 2);组间差异均无统计学意义(P > 0.05,表 2)。Endo-LIF组发生术后腰背痛1例、硬膜囊撕裂1例,并发症发生率为3.77%;MIS-TLIF组发生术后腰背痛4例、硬膜囊撕裂2例、椎间隙感染1例,并发症发生率为15.09%;2组并发症发生率差异有统计学意义(P < 0.05)。2组术后12个月融合率均为100%。2组典型病例影像学资料见图 23

表 2 2组手术相关评价指标 Tab. 2 Surgery-related evaluation indexes in 2 groups

图 2 Endo-LIF组典型病例影像学资料 Fig. 2 Imaging data of a typical case in Endo-LIF group 女,58岁,腰痛5年,加重伴左下肢疼痛、麻木6个月  a:术前侧位X线片示腰椎退行性变,L4/L5椎间盘突出,L4椎体滑脱  b、c:术前矢状位MRI示L4/L5椎间盘突出,横断面MRI示L4,5椎管狭窄  d、e:术后3个月正侧位X线片示融合器位置良好 Female, 58 years old, low back pain for 5 years, aggravated with left lower limb pain and numbness for 6 months  a: Preoperative lateral roentgenograph shows lumbar degenerative changes, L4/L5 disc herniation, L4 spondylolisthesis  b, c: Preoperative sagittal MRI shows L4/L5 disc herniation, and cross-sectional MRI shows L4, 5 spinal stenosis  d, e: Anterior and lateral roentgenographs at postoperative 3 months show cage is in good position

图 3 MIS-TLIF组典型病例影像学资料 Fig. 3 Imaging data of a typical case in MIS-TLIF group 男,68岁,腰痛3年,加重伴双下肢麻木、乏力1年  a:术前腰椎侧位X线片腰椎退行性变,L4不稳,L4/L5椎间孔狭窄  b、c:术前矢状位MRI示L4/L5椎间盘突出,横断面MRI示L4/L5椎间盘膨出、黄韧带肥厚、椎管狭窄  d、e:术后3个月腰椎正侧位X线片示融合器位置良好 Male, 68 years old, low back pain for 3 years, aggravated with numbness and weakness of both lower limbs for 1 year  a: Preoperative lateral roentgenograph shows lumbar degenerative changes, L4 instability and L4/L5 stenosis of foramina  b, c: Preoperative sagittal MRI shows L4/L5 disc herniation, and cross-sectional MRI shows L4/L5 disc prolapse, hypertrophic ligamentum flandum and spinal canal stenosis  d, e: Anterior and lateral roentgenographs at postoperative 3 months show cage is in good position
3 讨论

DLSS的主要病理改变为椎间盘突出、小关节增生及黄韧带肥厚等,多数患者早期病情隐匿,易被忽略,随着病情进展,逐渐出现腰腿痛、间歇性跛行等症状,严重者会伴随退行性腰椎失稳、侧凸或后凸等情况,影响患者腰椎功能[10-11]。目前临床主张DLSS的治疗目的主要是解除神经压迫并彻底减压,以缓解腰腿疼痛、改善腰椎功能[12-13]。MIS-TLIF是治疗DLSS的常用术式,经椎间孔在Quadrant通道系统辅助下摘除髓核组织,置入填充有自体骨粒的融合器,以达到支撑、融合的效果,疗效良好[14]。Endo-LIF术中采用脊柱内窥镜系统,不仅能确保骨性减压范围,还能获得微创效果[15]。刘鋆宣等[16]的报道指出,Endo-LIF治疗DLSS的术后融合率与传统后路腰椎椎间融合术无显著差异,且早期腰痛改善更明显,腰椎功能恢复更快。本研究结果显示,与MIS-TLIF相比,Endo-LIF治疗DLSS能缩短手术时间,减少术中出血量和术后引流量,加速康复进程,与Kim等[17]的研究结果一致。分析原因为,MIS-TLIF术中无内窥镜系统的辅助,须采用C形臂X线机反复透视来确保手术操作的精准度,导致术中透视时间更长、次数更多,一定程度上延长了手术时间,且术中操作无法避免剥离椎旁肌,从而导致手术时间进一步延长、术后出血量明显增加,进而导致康复进程延缓[18]。Endo-LIF则在全可视脊柱内窥镜系统辅助下进行手术操作,可有效减少术中透视次数和辐射暴露,同时在经皮套筒的保护下切除上关节突尖部、下关节突外缘、突出的椎间盘及对侧黄韧带,在内窥镜下完成微创减压、植骨融合操作,能明显缩短手术时间[19];且术中将内窥镜与通道相结合,可在直视条件下进行减压融合操作,无须再撑开椎旁深层的肌肉组织,有利于减少术中出血量,减小手术创伤范围,缩短手术时间,加快康复进程[20]。在上述研究基础上,本研究还通过对比手术前后创伤应激指标的变化发现,2组术后1 d、3 d血清前列腺素E、皮质醇、CRP、TNF-α水平较术前升高,但Endo-LIF组升高水平低于MIS-TLIF组,证实Endo-LIF能显著减轻手术创伤应激程度。考虑原因:①MIS-TLIF术中为了满足透视需求须不同程度剥离椎旁肌,且手术操作不是在直视条件下进行,会加重手术创伤应激反应[21];②Endo-LIF通过内窥镜可视化操作,能做到精准减压和融合器置入,可有效保护神经根组织,减少软组织及骨骼损伤,减轻对邻近节段生物力学的干扰[22-23]。因此,Endo-LIF的手术创伤更轻,这也是Endo-LIF能加快DLSS患者术后康复进程的主要原因之一。

本研究结果还显示,Endo-LIF组术后7 d、术后3个月腰痛及下肢痛VAS评分、ODI及JOA评分较MIS-TLIF组均改善更明显,表明Endo-LIF治疗DLSS减轻腰腿疼痛更显著,更有利于腰椎功能恢复,这与Endo-LIF手术创伤小、术后恢复快、术中保护脊柱稳定性和神经根组织等原因有关。而2组患者在椎间隙高度、腰椎前凸角、硬膜囊横截面积、椎间孔面积等影像学数据改善方面无明显差异,2组术后12个月融合率均为100%,提示Endo-LIF与MIS-TLIF均具有确切的融合效果,能有效纠正病变节段结构改变[24-25]。既往研究[26-27]显示,Endo-LIF手术时间短、术中出血量少、创伤应激反应轻,术中能通过扩张通道经肌间隙直达手术操作位置,无须剥离术区肌肉,从而减少瘢痕组织形成,降低术后并发症风险。本研究结果亦提示,Endo-LIF组并发症发生率明显低于MIS-TLIF组。但须注意的是,Endo-LIF的适应证有限,无法应用于合并重度腰椎滑脱、多节段椎管狭窄及严重椎间隙塌陷的DLSS患者,加之其学习曲线较为陡峭,初期手术时间较长,存在术中减压不充分的风险[28]。因此,临床应严格把握Endo-LIF适应证,且术者须具备丰富的Endo-LIF手术经验,以确保手术效果与安全性。

本研究的局限性在于未进行远期随访,无法获取DLSS患者术后远期预后的相关数据,今后须延长随访时间做进一步探讨。综上,与MIS-TLIF相比,Endo-LIF治疗DLSS能缩短手术时间,减少术中出血量和术后引流量,加速康复进程,减轻创伤应激及疼痛程度,促进腰椎功能恢复,且并发症发生率较低,具有明显优势,值得临床推广。

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