中国组织工程研究

中国组织工程研究 ›› 2018, Vol. 22 ›› Issue (19): 3000-3004.doi: 10.3969/j.issn.2095-4344.0304

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不同治疗方法减轻老年退行性骨质疏松性胸腰椎体压缩性骨折腰背部疼痛的差异：2年随访的非随机，对照临床试验方案及预试验结果

王 凯，李春亮，朱海勇，王 裕，张志进   

  1. 青海省人民医院，青海省西宁市 810007
  • 出版日期:2018-07-08 发布日期:2018-07-08
  • 通讯作者: 李春亮，硕士，副主任医师。青海省人民医院，青海省西宁市 810007
  • 作者简介:王凯，男，1964年生，副主任医师。

Three methods for reducing back pain in older adult patients with age-related osteoporotic vertebral compression fractures of the thoracolumbar spine: protocol for a 2-year follow-up non-randomized controlled trial and preliminary results

Wang Kai, Li Chun-liang, Zhu Hai-yong, Wang Yu, Zhang Zhi-jin   

  1. Qinghai Provincial People’s Hospital, Xining 810007, Qinghai Province, China
  • Online:2018-07-08 Published:2018-07-08
  • Contact: Li Chun-liang, Master, Associate chief physician, Qinghai Provincial People’s Hospital, Xining 810007, Qinghai Province, China
  • About author:Wang Kai, Associate chief physician, Qinghai Provincial People’s Hospital, Xining 810007, Qinghai Province, China

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骨质疏松性胸腰椎体压缩性骨折特点：患者会出现腰背部剧烈疼痛，活动严重受限，甚者不能下床、生活不能自理，使患者生活质量受到严重影响。
经皮球囊扩张椎体后凸成形：即通过椎弓根扩张椎体后向椎体内注入骨水泥的方法，以达到增强椎体强度和稳定性、防止塌陷、缓解腰背疼痛，甚至部分恢复椎体高度和生理曲度的目的的手术方法。
 
摘要
背景：骨质疏松性腰椎压缩性骨折患者主要临床表现为腰背部疼痛。经皮球囊扩张后凸成形术(percutaneouskyphoplasty，PKP)和经皮椎体成形术(percutaneous vertebroplasty，PVP)治疗是骨科治疗的首选方式。课题组以往的研究结果显示，PKP和PVP可有效缓解骨质疏松性胸腰椎体压缩性骨折术后6个月腰背部疼痛，但更长期随访的止痛效果尚未进行观察。
目的：作者设计了前瞻性，非随机，对照临床试验方案，旨在系统观察3种治疗方法：PKP，PVP及非手术疗法对老年退行性骨质疏松性胸腰椎体压缩性骨折患者腰背部疼痛的中长期止痛效果差异，并全面分析腰背部疼痛的危险因素。
方法：拟纳入青海省人民医院老年退行性骨质疏松性胸腰椎体压缩性骨折患者900例，按治疗方式的不同分为3组，PKP组和 PVP组分别接受PKP和 PVP治疗，非手术治疗组接受康复训练和中药治疗，每组300例，术后随访1周及1，3，6，12，24个月。研究的主要观察指标为术后24个月腰背部疼痛发生率。研究的次要观察指标为术后1周及术后1，3，6，12个月腰背部疼痛发生率；术前、术后1周及术后1，3，6，12，24个月的目测类比评分，Oswestry功能障碍指数评分，日本骨科学会(JOA)腰痛评分，胸腰部椎体X射线形态；术后1周及术后1，3，6，12，24个月不良反应发生率。在方案设计前，作者以预试验方案得到了621例患者的结果，显示PKP或PVP术后6个月患者的目测类比评分和Oswestry功能障碍指数较治疗前均显著降低(P < 0.05)，腰背部疼痛发生率为15%，腰背部疼痛的危险因素为术后发生骨水泥渗漏及骨水泥渗漏的方向、体积、范围和不良反应(P < 0.05)。试验经青海省人民医院医学伦理委员会批准(审批单位：青海省人民医院，审批时间：2017年4月，审批号：RM006G)。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3月，试验于2018年9月开始招募患者及数据收集，2019年9月完成对象招募，2021年10月进行结果指标分析，2021年11月完成试验。文章结果将以科学会议报道，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：ChiCTR1800016493)，注册方案版本号1.0。
讨论：试验希望明确，PKP，PVP及非手术治疗3种方法哪种对老年退行性骨质疏松性胸腰椎体压缩性骨折患者腰背部疼痛的缓解效果最佳。

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: 0000-0001-6041-7295(李春亮)

关键词: 骨质疏松, 胸腰椎体压缩性骨折, 腰背部疼痛, 老年人, 经皮球囊扩张后凸成形术, 经皮椎体成形术

Abstract:

BACKGROUND: Osteoporotic vertebral compression fracture of the thoracolumbar spine is clinically manifested as back pain. Percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) are the preferred treatment methods of this disorder. Our previous results showed that PKP and PVP can effectively reduce the back pain in patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine at 6 months post-surgery. Little is documented about longer follow-up for back pain relief after PKP and PVP.

OBJECTIVE: A prospective, non-randomized, controlled trial was design to investigate the long-term and medium-term back pain relief of PKP, PVP and non-surgical treatment in older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine, and analyze the risk factors of back pain.
METHODS: This study will include 900 older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine scheduled to receive treatment in Qinghai Provincial People’s Hospital and assign them to receive PKP, PVP or non-surgical (rehabilitation training and traditional Chinese medicine) treatments (n=300 per treatment method). These included patients were followed up at 1 week, 1, 3, 6, 12, and 24 months. The primary outcome measure of this study is incidence of back pain at 24 months post-surgery. The secondary outcome measures are incidence of back pain at 1 week, 1, 3, 6 and 12 months post-surgery; Visual Analogue Score, Oswestry Disability Index, Japanese Orthopedic Association score, and X-ray morphology of the thoracolumbar spine at baseline (prior to surgery) and at 1 week, 1, 3, 6, 12 and 24 months post-surgery; incidence of adverse events at 1 week, 1, 3, 6, 12 and 24 months post-surgery.Results of 621 older adult patients with osteoporotic vertebral compression fracture of the thoracolumbar spine included in a pilot study revealed that at 6 months post PKP or PVP, Visual Analogue Score and Oswestry Disability Index were significantly decreased compared with prior to surgery, and the incidence of back pain was only 15%. In addition, the risk factors of back pain are bone cement leakage (direction, volume and scope) and adverse reactions (P < 0.05). This study was approved by Medical Ethics Committee of Qinghai Provincial People’s Hospital, China in April 2017 (approval No. RM006G). 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 March 2017. Patient recruitment and data collection will begin in September 2018 and end in September 2019. Data analysis will begin in October 2021 and end in November 2021.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: ChiCTR1800016493). Protocol version (1.0).
DISCUSSION: Findings from this study hope to help identify PKP, PVP or non-surgical treatment has the best back pain relief in older adult patients with age-related osteoporotic vertebral compression fracture of the thoracolumbar spine.

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, Osteoporosis, Lumbar Vertebrae

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