中国组织工程研究

中国组织工程研究 ›› 2018, Vol. 22 ›› Issue (23): 3698-3702.doi: 10.3969/j.issn.2095-4344.0295

• 骨与关节临床实践 clinical practice of the bone and joint • 上一篇    下一篇

俯卧位和侧卧位下经皮椎间孔镜摘除椎间盘治疗老年退行性腰椎间盘突出症：随机对照临床试验方案及预试验结果

许立臣，许卫兵，杨东方，张海滨   

  1. 大连医科大学附属大连市中心医院脊柱外科，辽宁省大连市  116033
  • 出版日期:2018-08-18 发布日期:2018-08-18
  • 通讯作者: 许立臣，大连医科大学附属大连市中心医院脊柱外科，辽宁省大连市 116033
  • 作者简介:许立臣，副主任医师。

Percutaneous transforaminal endoscopic discectomy for treatment of degenerative lumbar disc herniation in older adult patients: study protocol for a randomized controlled trial and preliminary results

Xu Li-chen, Xu Wei-bing, Yang Dong-fang, Zhang Hai-bin   

  1. Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, Dalian 116033, Liaoning Province, China
  • Online:2018-08-18 Published:2018-08-18
  • Contact: Xu Li-chen, Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, Dalian 116033, Liaoning Province, China
  • About author:Xu Li-chen, Associate chief physician, Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, Dalian 116033, Liaoning Province, China

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摘要：

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文题释义：
腰椎间盘突出症：其典型病状是可放射至足趾的下肢根性疼痛，可伴有单侧椎旁肌痉挛、腰部前屈受限、针刺觉减退、肌萎缩和反射改变。
经皮椎间孔镜椎间盘切除：是治疗腰椎间盘突出症的一项新的微创技术。与传统开放式椎间盘切除术相比，其拥有创伤小、出血少、术后康复快及疤痕小等优点。
 
摘要
背景：经皮椎间孔镜下椎间盘摘除术(percutaneous endoscopie lumbar discectomy，PELD)是治疗退行性腰椎间盘突出症的主要微创手术方式之一。目前，PELD术中患者体位选择方面仍有争议，大多数医生采用俯卧位，也有少部分医生倾向于选用侧卧位，但究竟何种体位的疗效及安全性更佳，目前相关研究较少。
目的：试验观察了俯卧位和侧卧位下经皮椎间孔镜下椎间盘摘除治疗老年退行性腰椎间盘突出症的疗效及安全性。
方法：试验将纳入来自大连医科大学附属大连市中心医院脊柱外科的老年退行性腰椎间盘突出症患者168例，随机分为2组，均采用PELD治疗，俯卧位组和侧卧位组术中体位分别为为俯卧位和侧卧位，每组84例。术后随访2，6，12个月。研究的主要结局指标为术后12个月采用Oswestry功能障碍指数评分评估患者腰椎疼痛症状改善情况；研究的次要结局指标为术前(基线期)、术后2，6个月的Oswestry 功能障碍指数评分变化；术前、术后2，6，12个月腰椎X射线形态，目测类比评分及腰椎JOA功能评分；术后2，6，12个月改良Macnab疗效优良率；术前、术中、术后1 h血氧分压及血二氧化碳分压；术中平均动脉压，Likert评分，升压药使用次数及剂量；术后12个月腰椎间盘突出症复发率及不良反应发生率。作者前期预试验观察了54例患者的情况，俯卧位组26例和侧卧位组28例患者术后2个月目测类比评分及Oswestry 功能障碍指数评分较同组术前均得到有效缓解(P < 0.05)。术中动脉血气分析可见两组间血氧分压及血二氧化碳分压对比差异均有显著性意义(P < 0.05)，两组患者术后2个月目测类比评分、Oswestry 功能障碍指数评分较同组术前均得到有效缓解(P < 0.05)。试验经大连医科大学附属大连市中心医院医学伦理委员会批准(审批单位：大连医科大学附属大连市中心医院，审批时间：2018年5月22日，审批号：2018-012-01)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者对试验方案和过程均知情同意，并签署知情同意书。试验设计时间为2017年12月，试验于2018年8月至开始进行患者招募及数据收集，2019年8月患者招募完成，2020年10月进行结果指标分析，2020年11月试验完成。文章结果将以科学会议报告，或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号：ChiCTR1800016399)，注册方案版本号1.0。
讨论：在预试验的基础上，扩大样本量希望明确俯卧位和侧卧位PELD在治疗老年退行性腰椎间盘突出症时近中期疗效及安全性的差异，探索一种适合老年患者手术的最佳体位。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程
ORCID: 0000-0002-4118-6783(许立臣)

关键词: 退行性腰椎间盘突出症, 俯卧位, 侧卧位, 经皮椎间孔镜下椎间盘摘除, 老年, Oswestry功能障碍指数, 疼痛, 不良反应, 组织工程

Abstract:

 BACKGROUND: Percutaneous transforaminal endoscopic discectomy (PTED) is a major minimally invasive surgical method for the treatment of degenerative lumbar disc herniation. The choice of posture for patients undergoing PTED is controversial. Surgeons tend to perform PTED with the patient in the prone position rather than in the lateral position. Little is documented on which posture has higher efficacy and safety.

OBJECTIVE: To investigate the efficacy and safety of the prone position versus lateral position for older adult patients undergoing PTED for the treatment of degenerative lumbar disc herniation.
METHODS: This study will include 168 older adult patients with degenerative lumbar intervertebral disc herniation who receive treatment in the Department of Spine Surgery, Dalian Municipal Central Hospital Affiliated to Dalian Medical University, China. These patients will be randomized to undergo PTED in either the prone or lateral position (n= 84 patients in each surgical position). After surgery, all patients will be followed up for 2, 6, and 12 months. The primary outcome is the Oswestry Disability Index at 12 months postoperatively. This index is used to evaluate the improvement in low back pain. The secondary outcomes are the Oswestry Disability Index preoperatively (at baseline) and at 2 and 6 months postoperatively; X-ray morphology of the lumbar spine, visual analog scale score, and Japanese Orthopaedic Association (JOA) score preoperatively and at 2, 6, and 12 months postoperatively; modified MacNab grade at 2, 6, and 12 months postoperatively; partial pressures of oxygen and carbon dioxide preoperatively, intraoperatively, and 1 hour postoperatively; mean arterial pressure, Likert score, and times and doses of vasopressor used intraoperatively; and the incidence of recurrent lumbar intervertebral disc herniation and incidence of adverse reactions 12 months postoperatively. The results of 54 patients included in a pilot study of PTED showed that regardless of use of the prone position (n=26) or lateral position (n=28), the visual analog scale score and Oswestry Disability Index at 2 months postoperatively were significantly lower than those before surgery (P < 0.05). Intraoperative arterial blood gas analysis revealed that the partial pressures of oxygen and carbon dioxide were significantly different between patients in the prone and lateral positions (P < 0.05). This study was approved by Medical Ethics Committee of Dalian Municipal Central Hospital Affiliated to Dalian Medical University, China in May 22, 2018 (approval No. 2018-012-01). This study protocol will be performed in strict accordance with the Declaration of Helsinki. Written informed consent will be obtained from the participants. The study protocol was designed in December 2017. Patient recruitment will begin in August 2018 and end in August 2019. Data analysis will begin in October 2020 and end in November 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016399). Protocol version (1.0).
DISCUSSION: Based on the pilot study, future studies involving larger sample sizes are needed to investigate the short- and medium-term efficacy and safety of the prone versus lateral position for patients undergoing PTED for degenerative lumbar intervertebral disc herniation and to identify a better surgical posture suitable for older adult patients. 

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Lumbar Vertebrae, Intervertebral Disk

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