脊柱外科杂志  2024, Vol.22 Issue(5): 295-301   PDF    
新型经椎间孔入路经皮内窥镜手术治疗伴基础疾病的腰椎退行性疾病
贾瑞平1, 马添乐2,3, 顾宇彤2,3, 连小峰4, 许国华5     
1. 新乡市中心医院(新乡医学院第四临床学院)东区骨科, 新乡 453000;
2. 复旦大学附属中山医院骨科, 上海 200032;
3. 沪西南脊柱外科中心, 上海 200032;
4. 上海市第六人民医院骨科, 上海 200233;
5. 海军军医大学长征医院骨科, 上海 200003
摘要: 目的 评估新型经椎间孔入路经皮内窥镜手术(PTES)治疗伴基础疾病的腰椎退行性疾病(LDD)的疗效、安全性及可行性。方法 回顾性分析2017年6月—2019年4月复旦大学附属中山医院采用新型PTES治疗并获得2年以上随访的196例单节段LDD患者临床资料,其中89例伴基础疾病(A组),107例不伴基础疾病(B组)。记录2组手术时间、切口长度、术中透视次数、术中出血量、住院时间及并发症发生情况。于术前,术后即刻,术后1、2、3、6、12个月及末次随访时采用疼痛视觉模拟量表(VAS)评分评估患者下肢疼痛程度;术前、末次随访时采用Oswestry功能障碍指数(ODI)评估腰椎功能情况;末次随访时采用改良MacNab标准评估疗效。结果 所有手术顺利完成。2组手术时间、切口长度、术中透视次数、术中出血量、住院时间差异均无统计学意义(P>0.05)。2组术后即刻下肢痛VAS评分较术前明显改善,且在术后1、2、3、6、12个月及末次随访时较术后即刻进一步改善,差异均有统计学意义(P < 0.05)。2组末次随访时ODI较术前明显改善,差异有统计学意义(P < 0.05)。组间术后各时间点VAS评分和ODI差异均无统计学意义(P>0.05)。根据改良MacNab标准,末次随访时2组疗效优良率差异无统计学意义(P>0.05)。2组并发症发生率差异无统计学意义(P>0.05)。2组均未发生伤口感染、永久性神经损伤、腹部器官损伤、大血管破裂等并发症。结论 新型PTES治疗伴基础疾病的LDD安全、有效、微创,值得临床推广。
关键词: 腰椎    椎间盘退行性变    椎管狭窄    内窥镜检查    外科手术,微创性    
New type percutaneous transforaminal endoscopic surgery for lumbar degenerative diseases with underlying diseases
Jia Ruiping1, Ma Tianle2,3, Gu Yutong2,3, Lian Xiaofeng4, Xu Guohua5     
1. Department of Orthopeaedics, East Ward of Xinxiang Central Hospital, Fourth Clinical Collage of Xinxiang Medical Collage, Xinxiang 453000, Henan, China;
2. Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai 200032, China;
3. Shanghai Southwest Spine Surgery Center, Shanghai 200032, China;
4. Department of Orthopaedics, Sixth People's Hospital, Shanghai 200233, China;
5. Department of Orthopaedics, Changzheng Hospital, Naval Medical University, Shanghai 200003, China
Abstract: Objective To evaluate the efficacy, safety and feasibility of the new type percutaneous transforaminal endoscopic surgery(PTES) for the treatment of lumbar degenerative diseases(LDD) with underlying diseases. Methods From June 2017 to April 2019, the data of 196 patients with single-segment LDD treated by the new type PTES and followed up for more than 2 years in Zhongshan Hospital Affiliated to Fudan University were retrospectively analyzed, including 89 patients with underlying diseases(group A) and 107 without underlying diseases(group B). Operation time, incision length, intraoperative fluoroscopy frequency, intraoperative blood loss, hospital stay and complications were recorded in the 2 groups. The intensity of lower limb pain was assessed by the visual analogue scale(VAS) score at pre-operation, immediate post-operation, postoperative 1, 2, 3, 6, 12 months and the final follow-up; and the Oswestry disability index(ODI) was used to assess the lumbar spine function at pre-operation and the final follow-up; and the clinical efficacy was evaluated by the modified MacNab criteria at the final follow-up. Results All the operations were successfully completed. There was no significant difference in operation time, incision length, intraoperative fluoroscopy frequency, intraoperative blood loss and hospital stay between the 2 groups(P>0.05). The VAS score of lower limb pain of the 2 groups was significantly improved at immediate post-operation, and further improvement was observed at postoperative 1, 2, 3, 6, 12 months and at the final follow-up, all with a statistical significance(P < 0.05). The ODI of the 2 groups was significantly improved at the final follow-up, and the difference was statistically significant(P < 0.05). There was no significant difference in VAS score and ODI between the 2 groups at each time point after surgery(P>0.05). According to the modified MacNab criteria, there was no significant difference in the excellent and good rate between the 2 groups at the final follow-up(P>0.05). There was no significant difference in the incidence of complications between the 2 groups(P>0.05). No complications such as wound infection, permanent nerve injury, abdominal organ injury or rupture of large blood vessels occurred in the 2 groups. Conclusion The new type PTES is safe, effective and minimally invasive in the treatment of LDD with underlying diseases, thus being worthy of clinical promotion.
Key words: Lumbar vertebrae    Intervertebral disc degeneration    Spinal stenosis    Endoscopy    Surgical procedures, minimally invasive    

腰椎退行性疾病(LDD)包括腰椎椎间盘突出症(LDH)、腰椎椎管狭窄症(LSS)等,常见症状为神经受压导致下肢疼痛,是脊柱外科常见病和多发病。卧床休息或口服药物等非手术治疗效果不佳、症状严重影响生活质量的患者应考虑手术治疗。伴有基础疾病(高血压、糖尿病、重要器官功能障碍、心脏术后、肝或肾移植术后等)的LDD患者手术治疗的有效性和安全性是临床面临的主要挑战。传统开放手术有广泛剥离椎旁肌、破坏骨性结构、出血量大、手术时间长、患者术后恢复慢等缺点[1]。Yeung脊柱内窥镜系统(YESS)、经椎间孔脊柱内窥镜系统(TESSYS)等技术具有切口小、软组织和骨性结构破坏少、患者术后恢复快等优点[2-7]。基于传统经椎间孔入路内窥镜技术,本研究组设计出一种简便、易学的新型经椎间孔入路经皮内窥镜手术(PTES)[8-15],其操作方便、定位简单、穿刺容易、术中透视少、手术时间短,为治疗LDD提供了一种新的方法。本研究采用新型PTES治疗伴/不伴基础疾病的LDD患者,评估其安全性及可行性,现报告如下。

1 资料与方法 1.1 一般资料

纳入标准:①单侧下肢痛或双侧对称下肢痛,伴/不伴间歇性跛行;②经MRI和CT检查证实为单节段LDH或LSS,神经压迫与临床症状一致;③经过3个月规范非手术治疗效果不佳,甚至症状进一步加重,严重影响患者工作和生活质量;④基础疾病控制稳定,能够耐受局部麻醉;⑤精神状态稳定,具有理解和独立思考能力;⑥术后按计划随访时间 > 2年。排除标准:①存在凝血功能障碍等手术禁忌证;②合并心、肺等重要器官功能衰竭;③合并Ⅱ度及以上腰椎滑脱;④有精神类疾病,术中无法配合保持俯卧位;⑤术区局部组织或伤口存在感染。

按照上述标准,纳入2017年6月—2019年4月复旦大学附属中山医院日间病房收治(住院时间≤4 d)采用新型PTES治疗并随访 > 2年的196例单节段LDD患者。所有患者术前均完善X线、CT及MRI检查,明确责任节段,以及是否伴有钙化、腰椎不稳、脊柱侧凸或L5/S1高髂嵴(L4下终板不高于双侧髂嵴最高点连线)。其中89例伴基础疾病(A组,高血压22例、糖尿病24例、慢性支气管炎4例、肺气肿3例、冠心病5例、心律失常3例、心脏瓣膜术后2例、心脏支架植入术后4例、脑梗死3例、肝癌切除术后4例、肝移植术后3例、肾功能不全血液透析状态3例、肾移植术后3例、风湿病3例、干燥综合征1例、系统性红斑狼疮2例);107例不伴基础疾病(B组)。2组患者基线资料差异无统计学意义(P > 0.05,表 1),具有可比性。本回顾性队列研究符合《赫尔辛基宣言》,并获得复旦大学附属中山医院医学伦理委员会审核备案,所有资料使用均获得患者知情同意并签署知情同意书。肝/肾移植术后患者依据《伊斯坦布尔宣言》,所有器官供体患者均签署知情同意自愿捐赠书。

表 1 2组患者基线资料 Tab. 1 Baseline data of 2 groups
1.2 手术方法及术后处理

所有手术由同一手术团队完成。患者在可透视骨科手术床上保持俯卧位,腹部下方放置弓形垫,使髋关节尽量屈曲。C形臂X线机正位透视确定责任椎间隙水平线,此定位线与后正中线的交点为椎间盘解剖中心的体表投影,穿刺进针点位于背部平面转侧面的拐点,将该进针点命名为“顾氏点”(图 1a)。患者局部麻醉成功后,瞄准手术节段水平定位线与后正中线交点的垂线,与水平面成角约45°(25° ~ 85°)插入18G穿刺针,穿刺成功后,侧位透视确认穿刺针尖位于目标椎间隙后1/3或椎间隙后缘附近,正位透视确认穿刺针尖到达下位椎体椎弓根外缘附近。逐级扩张软组织,沿直径为6.3 mm的导棒插入直径为8.8 mm的大号环锯保护套筒并将其斜面锚于关节突上,压低套筒减小倾斜角度,插入直径为7.5 mm的环锯,切除关节突腹侧骨质,扩大椎间孔(即下压式扩孔技术,图 1b)。出现落空感后,正位透视确认环锯顶端超过椎弓根内缘,侧位透视确认环锯顶端到达目标椎间隙后缘附近。沿导棒置入直径为7.5 mm的工作通道,内窥镜下切除肥厚的黄韧带及突出的髓核组织,显露同侧走行神经根,扩大侧隐窝;显露对侧走行神经根,扩大中央椎管,单侧入路双侧减压,术毕。

图 1 PTES穿刺技术和扩孔技术 Fig. 1 PTES puncture technique and press-down enlargement of foramen a:穿刺进针点(顾氏点)  b:下压式扩孔技术 a: Puncture insertion point(Gu's point)  b: Press-down enlargement of foramen

术后平躺至次日;术后3 d内以卧床为主,二便可下床;术后第4天开始下床行走锻炼;术后1周可恢复工作,腰围佩戴2周。术后继续基础疾病治疗,如控制血压、血糖和维持重要器官功能稳定,需要抗凝治疗的患者从术后第4天开始。

1.3 观察指标

记录2组手术时间、切口长度、术中透视次数、术中出血量、住院时间及并发症发生情况。于术前,术后即刻,术后1、2、3、6、12个月及末次随访时采用疼痛视觉模拟量表(VAS)评分[16]评估患者下肢疼痛程度;术前、末次随访时采用Oswestry功能障碍指数(ODI)[18]评估腰椎功能情况;末次随访时采用改良MacNab标准[17]评估疗效:优,症状完全消失,活动不受限;良,下肢有轻微疼痛,对工作生活无影响;可,功能改善,但有间歇性疼痛,对工作生活有一定影响;差,症状无改善,需要进一步手术治疗。

1.4 统计学处理

采用SPSS 25.0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,组内不同时间点比较采用配对样本t检验;计数资料以例数表示,组间比较采用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。2组手术时间、切口长度、术中透视次数、术中出血量、住院时间等差异均无统计学意义(P > 0.05,表 2)。2组术后各随访时间点下肢痛VAS评分较术前明显改善,术后1、2、3、6、12个月及末次随访时下肢痛VAS评分较术后即刻明显改善,差异均有统计学意义(P < 0.05,表 2)。2组末次随访时ODI较术前明显改善,差异有统计学意义(P < 0.05,表 2)。组间术后各时间点VAS评分和ODI差异均无统计学意义(P > 0.05,表 2)。根据改良MacNab标准,末次随访时2组疗效优良率差异无统计学意义(P > 0.05,表 2)。A组发生下肢反跳痛2例、神经根袖破裂2例,并发症发生率为4.6%;B组发生下肢反跳痛3例、神经根袖破裂3例,并发症发生率为5.6%;2组并发症发生率差异无统计学意义(P > 0.05)。2组均未发生伤口感染、永久性神经损伤、腹部器官损伤、大血管破裂等并发症。末次随访时,A组均未出现基础疾病加重或复发病例;B组1例于术后52个月时复发,再次采用PTES治疗。A组典型病例影像学资料见图 2

表 2 2组手术相关指标和疗效评估 Tab. 2 Surgery-related indexes and efficacy evaluation in 2 groups

图 2 A组典型病例影像学资料 Fig. 2 Imaging data of a typical case of group A 女,85岁,合并糖尿病、高血压,腰痛及右下肢痛2年,加重1个月,采用局部麻醉下PTES治疗  a ~ e:术前MRI和CT示L4/L5退行性变、椎间盘脱出、侧隐窝狭窄,伴有神经压迫  f:术中透视定位L4/L5水平线体表投影  g:穿刺进针点(顾氏点)位于背部平面转侧面拐角处  h、i:穿刺成功后,侧位透视示穿刺针尖位于椎管内、L4/L5椎间隙后缘附近,正位透视确认穿刺针尖到达椎弓根外缘附近  j、k:扩张软组织后行下压式扩孔,出现落空感后正位透视示环锯尖端超过椎弓根内缘,侧位透视示环锯尖端位于L4/L5椎间隙后缘附近  l、m:内窥镜下切除肥厚的黄韧带和脱出的椎间盘,扩大侧隐窝,显露神经根  n:手术切口约8 mm  o ~ r:术后2年过伸、过屈侧位X线片和CT未发现新的腰椎不稳(箭头,扩孔后的椎间关节) Female, 85 years old, complicated with diabetes, hypertension, low back pain and right lower extremity pain for 2 years, aggravated for 1 month, treated with PTES under local anesthesia  a-e: Preoperative MRIs and CTs show L4/L5 degeneration, disc herniation, lateral recess stenosis, accompanied by nerve compression  f: Intraoperative fluoroscopy positioning L4/L5 horizontal line body surface projection  g: Puncture point(Gu's point) is located at corner of lateral side of dorsal plane  h, i: Lateral fluoroscopy after successful puncture shows that puncture needle tip is located in spinal canal and near posterior margin of L4/L5 intervertebral space, and anterior fluoroscopy confirms that puncture needle tip reaches outer edge of pedicle  j, k: After soft tissue expansion, press-down enlargement of foramen is performed, and a sense of disillusionment occurred. Anterior fluoroscopy confirms that tip of ring saw exceeds inner edge of pedicle, and lateral fluoroscopy confirms that tip of ring saw is located near posterior edge of L4/L5 intervertebral space  l, m: Hypertrophied ligamenta flavum and prolapsed intervertebral disc are removed endoscopically, lateral recess is enlarged, and nerve root is exposed  n: Surgical incision is approximately 8 mm  o-r: Hyperextension and hyperflexion lateral roentgenographs and CTs at postoperative 2 years show no new lumbar instability(arrow, intervertebral joint after foramen enlargement)
3 讨论

对于伴基础疾病的LDD患者,传统开放手术风险较高,需要全身麻醉,手术创伤大、术中出血量多、患者术后恢复时间长[19]。随着微创脊柱外科不断发展,内窥镜技术已广泛应用于临床,其疗效与开放手术相近,且可在局部麻醉下完成,软组织损伤明显减小,出血量明显降低,几乎不破坏脊柱稳定性,无须内固定,并发症少,术后患者恢复快[20-22],被认为是伴有基础疾病的LDD患者最理想的手术治疗选择。本研究结果也显示,2组患者术中出血量均 < 15 mL,手术切口的长度均 < 10 mm。本研究所有患者均入住日间病房,平均住院3(2 ~ 4)d,有助于减少患者心理压力,降低院内感染发生率,节约医疗资源,符合快速康复外科(ERAS)理念[23-24],且未发生伤口感染、永久性神经损伤、腹部器官损伤、大血管破裂等并发症。

经皮内窥镜下腰椎椎间盘切除术(PELD)是一种广泛使用的内窥镜技术,但其定位复杂,穿刺要求高,操作步骤多,导致术中透视次数多、手术时间长,学习曲线陡峭[23]。顾宇彤团队[8]于2017年首次报道新型PTES,穿刺进针点位于背部平面转侧面的拐角处(顾氏点),其位置不受年龄、性别及体型的影响,无须测量和透视[9-15]。相比其他内窥镜技术的穿刺进针点,顾氏点位置更靠内,且有以下优势。①避免损伤出口神经根。出口根由椎间孔内上穿出,向下外侧走行,如果进针点位于外侧,扩张椎间孔时容易刺激出口根。②避免L5/S1高髂嵴阻挡。顾氏点位置的髂嵴高度低于外侧的髂嵴最高点,L5/S1节段穿刺、扩张椎间孔不受高髂嵴影响。③缩短肥胖患者手术路径。进针点越偏离中线,手术入路越长,再加上肥胖患者过多的皮下脂肪组织,使得内窥镜手术需要更长的工作通道,顾氏点穿刺可缩短肥胖患者手术穿刺路径。④避免损伤腹腔脏器和大血管。经顾氏点穿刺,即使穿刺角度较大,针尖也会被脊柱的骨性结构阻挡,从而阻止穿刺针深入到前方腹腔脏器和大血管。PTES的穿刺目标不是一个固定点,穿刺的角度、路线更加灵活,降低了穿刺难度。扩大椎间孔时,将保护套筒斜面锚于关节突上并压低以减小倾斜角度,切除更多关节突腹侧骨质,即使穿刺角度与水平面呈角85°,工作通道同样可以进入椎管,摘除中央甚至对侧的突出髓核,这就是下压式扩孔技术,该技术使定位简单、穿刺容易的目标得以实现。此外,PTES术中使用直径为7.5 mm的环锯一次性扩大椎间孔,而不是逐级扩大椎间孔,操作方便,加上定位简单、穿刺容易,显著减少了术中透视次数,缩短了手术时间。

LDD患者伴/不伴基础疾病,其疾病特征都是类似的。伴/不伴节段不稳的单节段LDD患者只有单节段神经压迫症状,表现为单侧或双侧对称的下肢痛,偶有间歇性跛行;当发生LDH、侧隐窝狭窄或椎间孔狭窄时,表现为单侧下肢疼痛;中央椎管狭窄时,由于同一节段双侧走行根受压,出现双下肢对称性疼痛。PTES采用下压式扩孔技术,内窥镜下切除肥厚的黄韧带和突出的髓核,扩大侧隐窝,减压同侧走行根,使用可弯曲射频刀头及带角度的髓核钳切除中央及对侧后纵韧带、纤维环及髓核组织,显露对侧走行根,完成中央椎管的扩大,通过一个小切口实现双侧神经根减压。本研究结果显示,2组术后下肢痛VAS评分和ODI较术前显著改善,且末次随访时2组疗效优良率差异无统计学意义。

虽然部分患者术中扩大椎间孔时关节突受累,但术后影像学资料并未显示新发腰椎不稳。B组有1例患者于术后52个月时复发,再次采用PTES治疗,而A组没有患者复发。低复发率与术后腰部保养密切相关,须反复提醒患者做到“四不”:不弯腰、不提重物、不长时间保持同一姿势、咳嗽或打喷嚏时不要将力量集中于腰部[8-9, 14]。摘除破裂、突出的髓核后,椎间盘的剩余部分相对完整,可维持稳定,但术后不注重腰部保养会导致剩余髓核破裂,产生的碎片终会突出并再次压迫神经。

基础疾病对手术疗效和安全性的影响主要是通过术后与基础疾病相关的并发症发生率的上升而体现。为了确保伴有基础疾病的LDD患者内窥镜手术的疗效及安全,本研究提出以下建议。①术前控制好基础疾病,应通过检查评估基础疾病的严重程度,针对不同的基础疾病做好充分术前准备。高血压患者收缩压控制在90 ~ 180 mmHg(1 mmHg=0.133 kPa),舒张压控制在60 ~ 110 mmHg[25-26];糖尿病患者空腹血糖控制在6 ~ 10 mmol/L[27-28];口服抗血小板药物,如阿司匹林、氯吡格雷和双嘧达莫,术前至少停用7 d[29-30];评估伴心、脑血管疾病患者的术中可能风险,必要时请相关科室专家进行术前评估。②局部麻醉时,内窥镜术中静脉辅助使用右美托咪定等镇静镇痛药物来提高患者的手术顺应性[31-33],按照监测麻醉管理(MAC)标准[28]镇静深度达到Ⅲ级,需要时可唤醒;术中须使用心电监护,及时发现问题、解决问题。③术后继续规范治疗基础疾病。上述围手术期的综合措施可显著降低手术创伤对患者重要脏器功能的影响,使患者术后与基础疾病相关的并发症发生风险显著下降。本研究结果亦证实,A组所有患者术后6个月内未发现基础疾病加重,未发生与基础疾病相关的并发症。

本研究的不足:①为单中心研究;②未进行PTES与其他脊柱内窥镜技术的比较。未来将开展多中心研究及前瞻性对照研究,比较PTES与YESS、PELD、后路单通道内窥镜、单侧双通道内窥镜(UBE)等技术的差异。综上所述,PTES治疗伴基础疾病的LDD安全、有效、微创,值得临床推广。

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