Degenerative disc disease

退行性椎间盘病
  • 文章类型: Journal Article
    背景:本研究的目的是确定微创经椎间孔腰椎椎间融合术(MISTLIF)与经Wiltse入路改良开放TLIF治疗腰骶区退行性疾病的临床和放射学结果。术后48个月对结果进行评估。
    方法:回顾了2017年5月至2021年5月接受MISTLIF和改良开放TLIF的患者的放射学数据和医疗记录。监测以评估手术结果的参数是:临床状态,操作时间,失血,对患者的辐射剂量,出院日,镇痛消耗,聚变,和并发症发生率。对于功能评估,背痛视觉模拟评分(VAS-BP),腿部疼痛的VAS(VAS-LP),Oswestry残疾指数(ODI),患者满意度(PSR)和并发症发生率。
    结果:本研究包括57例患者,随机分为两组:30例采用MISTLIF技术进行手术,和27通过Wiltse方法使用改进的开放TLIF技术进行操作。两组48个月的随访率相似。患者在基线ODI方面没有显著差异,VAS-BP,或VAS-LP。围手术期,MISTLIF与明显减少失血相关(167.3±80.0vs.297.9±81.5ml,p=1.1E-05),稍长的程序(185.7±45.2vs.183.1±66.4分钟,p=0.76),较低的辐射剂量(MIS16.9±7.1vs.22.0±9.7mGyOPENp=0.012),住院时间较短(MIS5.9±1.8vs.7.7±1.6天开放)。最常见的并发症是神经根炎,在MIS和TLIF组中分别占33%和37%,分别。第二个最常见的并发症是固定材料错位,TLIF组占18.5%,MIS组占20%。MIS组达到的融合水平为92.6%,而TLIF组为92.3%。MIS中镇痛药的消耗量较低。患者满意度(PSR)为90%。
    结论:腰骶部退行性疾病患者MISTLIF后的临床和放射学结果通常是有利的。MISTLIF与围手术期失血减少有关,较低的辐射剂量和较早的放电,但是MISTLIF和改良开放TLIF在48个月的残疾方面没有差异,背痛,腿部疼痛,生活质量,或患者满意度或并发症发生率。尽管随着时间的推移差异逐渐减少,MISTLIF在围手术期和术后早期具有不可否认的优势。
    BACKGROUND: The aim of this study was to determine the clinical and radiological outcomes of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) compared to modified open TLIF via the Wiltse approach for treatment of degenerative diseases of the lumbosacral region. The results were evaluated over a post-operative period of 48 months.
    METHODS: Radiological data and medical records of patients who underwent MIS TLIF and modified open TLIF between May 2017 and May 2021 were reviewed. Parameters monitored to evaluate the surgical results were: clinical status, operation time, blood loss, radiation dose to patient, day of discharge, analgesic consumption, fusion, and complications rate. For functional assessment, the Visual Analogue Scale for back pain (VAS-BP), VAS for leg pain (VAS-LP), Oswestry Disability Index (ODI), Patient Satisfaction Rate (PSR), and the complication rate were used.
    RESULTS: This study included 57 patients randomly divided into two groups: 30 operated on using the MIS TLIF technique, and 27 operated on using the modified open TLIF technique via the Wiltse approach. 48-month follow-up rates were similar for the two cohorts. Patients did not differ significantly at baseline in terms of ODI, VAS-BP, or VAS-LP. Perioperatively, MIS TLIF was associated with significantly less blood loss (167.3 ± 80.0 vs. 297.9 ± 81.5 ml, p = 1.1E-05), slightly longer procedures (185.7 ± 45.2 vs. 183.1 ± 66.4 minutes, p = 0.76), a lower radiation dose (MIS 16.9 ± 7.1 vs. 22.0 ± 9.7 mGy OPEN p = 0.012), and shorter hospitalisations (MIS 5.9 ± 1.8 vs. 7.7 ± 1.6 days OPEN). The most common complication was radiculitis, which accounted for 33% and 37% in the MIS and the TLIF groups, respectively. The second most common complication was malposition of the fixation material, which accounted for 18.5% in the TLIF group and 20% in the MIS group. The level of fusion achieved was 92.6% in the MIS group versus 92.3% in the TLIF group. There was lower consumption of analgesics in MIS. Patient Satisfaction Rate (PSR) was 90%.
    CONCLUSIONS: Clinical and radiological outcomes after MIS TLIF in patients with degenerative disease of the lumbosacral region are generally favourable. MIS TLIF was associated with decreased blood loss perioperatively, a lower radiation dose and an earlier discharge, but there was no difference between MIS TLIF and modified open TLIF in 48-month outcomes in terms of disability, back pain, leg pain, quality of life, or patient satisfaction rate or complication rate. Although the differences taper off over time, MIS TLIF has undeniable advantages in the perioperative and early postoperative periods.
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  • 文章类型: Journal Article
    背景:鉴别椎间盘退行性疾病(DDD),弥漫性特发性骨骼肥大(DISH),和轴向脊柱关节炎(axSpA)代表了下腰痛(LBP)患者的诊断挑战。我们旨在评估转诊到三级大学风湿病中心的LBP患者的真实队列中炎症和退行性成像特征的分布。
    方法:在对因LBP转诊的患者进行的回顾性横断面分析中,人口统计,症状信息,和可用的成像收集。在存在以下通常与SpA相关的病变之一的情况下,脊柱中考虑了SpA样变化:糜烂,硬化症,平方,和常规X光片(CR)和骨髓水肿(BMO)上的合成植物,侵蚀,硬化症,和MRI上的脂肪病变(FL)。SIJCR根据纽约标准进行评级;在核磁共振成像上,SIJ通过象限评估BMO,侵蚀,FL,硬化症和强直,类似于柏林SIJMRI评分系统使用的方法。风湿病学家的最终诊断是金标准。数据以描述性方式呈现,按病人和象限,并在三个诊断组之间进行比较。
    结果:在136名转诊患者中,71有DDD,38盘,和27axSpA;中位年龄62岁[IQR55-73],63%的男性。在CR上,腰椎中的axSpA样变化明显更高(50%,vs.DDD23%,DISH22%),在胸廓的盘中(28%,vs.DDD8%,axSpA12%),和DDD在颈椎(67%vs.DISH0%,axSpA33%)。核磁共振成像,胸部DISH的BMO明显更高(37%,vs.DDD22%,axSpA5%),并均匀分布在腰椎中(35-42%)。在胸椎的DISH和axSpA(56%和52%)以及腰椎的DDD和axSpA(65%和74%,分别)。在三组中,退行性变化很常见。在49%(axSpA76%,DDD48%,DISH29%)。
    结论:在DDD之间发现了显着的重叠,DISH,和axSpA用于炎性和退行性成像特征。特别是,在DISH患者的四分之一中发现了SpA样脊柱CR特征,在三分之一的患者中发现了MRIBMO。
    BACKGROUND: Differentiating between degenerative disc disease (DDD), diffuse idiopathic skeletal hyperostosis (DISH), and axial spondyloarthritis (axSpA) represents a diagnostic challenge in patients with low back pain (LBP). We aimed to evaluate the distribution of inflammatory and degenerative imaging features in a real-life cohort of LBP patients referred to a tertiary university rheumatology center.
    METHODS: In a retrospective cross-sectional analysis of patients referred for LBP, demographics, symptom information, and available imaging were collected. SpA-like changes were considered in the spine in the presence of one of the following lesions typically related to SpA: erosions, sclerosis, squaring, and syndesmophytes on conventional radiographs (CR) and bone marrow oedema (BMO), erosions, sclerosis, and fat lesions (FL) on MRI. SIJ CR were graded per New York criteria; on MRIs, SIJs were evaluated by quadrant for BMO, erosions, FL, sclerosis and ankylosis, similar to the approach used by the Berlin SIJ MRI scoring system. The final diagnosis made by the rheumatologist was the gold standard. Data were presented descriptively, by patient and by quadrant, and compared among the three diagnosis groups.
    RESULTS: Among 136 referred patients, 71 had DDD, 38 DISH, and 27 axSpA; median age 62 years [IQR55-73], 63% males. On CR, SpA-like changes were significantly higher in axSpA in the lumbar (50%, vs. DDD 23%, DISH 22%), in DISH in the thoracic (28%, vs. DDD 8%, axSpA 12%), and in DDD in the cervical spine (67% vs. DISH 0%, axSpA 33%). On MRI, BMO was significantly higher in DISH in the thoracic (37%, vs. DDD 22%, axSpA 5%) and equally distributed in the lumbar spine (35-42%). FL were significantly more frequently identified in DISH and axSpA in the thoracic (56% and 52%) and DDD and axSpA in the lumbar spine (65% and 74%, respectively). Degenerative changes were frequent in the three groups. Sacroiliitis (NY criteria) was identified in 49% (axSpA 76%, DDD 48%, DISH 29%).
    CONCLUSIONS: A significant overlap was found among DDD, DISH, and axSpA for inflammatory and degenerative imaging features. Particularly, SpA-like spine CR features were found in one-fourth of patients with DISH, and MRI BMO was found in one-third of those patients.
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  • 文章类型: Journal Article
    退变性椎间盘疾病(DDD)伴随着椎间盘(IVD)的结构变化。纤维环(AF)的细胞外基质降解与IVD的变性有关。胶原蛋白是IVD的重要组成部分。胶原杂交肽(CHP)是一种与降解胶原结合的工程蛋白质,我们用它来量化房颤中的胶原损伤。该方法用于比较从没有DDD的供体获得的AF样品与从针对症状性DDD进行手术的患者获得的AF样品。
    将新鲜的AF组织包埋在最佳切割温度化合物中,并以8μm的厚度冷冻切片。在切片上进行苏木精和伊红染色用于一般组织形态学评估。连续切片用Cy3缀合的CHP染色,并且在每个CHP染色的切片上对三个感兴趣区域(ROI)的Cy3阳性染色的平均荧光强度和面积分数进行平均。
    与非DDD样品相比,在DDD样品中检测到CHP的平均荧光强度(p=0.0004)和阳性染色面积百分比(p=0.00008)的增加。对于非DDD(R=0.98,p=5E-8)和DDD(R=0.79,p=0.0012)样品,平均荧光强度与阳性染色面积百分比之间均观察到显着相关性。非DDD和DDD组的性别和腰椎间盘水平亚组之间没有显着差异。只有组织病理学(非DDD与DDD)影响测量参数。组织病理学之间没有三向相互作用,性别,观察腰椎间盘水平。
    这些研究结果表明,与非DDD样品相比,DDD样品中AF胶原降解更大,如CHP染色增加所证明。两个测量参数之间的强正相关表明,当胶原蛋白降解发生时,它被这种技术检测到,并在整个组织中广泛存在。这项研究为DDD期间发生的与AF中胶原蛋白降解相关的结构改变提供了新的见解。
    UNASSIGNED: Degenerative disc disease (DDD) is accompanied by structural changes in the intervertebral discs (IVD). Extra-cellular matrix degradation of the annulus fibrosus (AF) has been linked with degeneration of the IVD. Collagen is a vital component of the IVD. Collagen hybridizing peptide (CHP) is an engineered protein that binds to degraded collagen, which we used to quantify collagen damage in AF. This method was used to compare AF samples obtained from donors with no DDD to AF samples from patients undergoing surgery for symptomatic DDD.
    UNASSIGNED: Fresh AF tissue was embedded in an optimal cutting temperature compound and cryosectioned at a thickness of 8 μm. Hematoxylin and Eosin staining was performed on sections for general histomorphological assessment. Serial sections were stained with Cy3-conjugated CHP and the mean fluorescence intensity and areal fraction of Cy3-positive staining were averaged for three regions of interest (ROI) on each CHP-stained section.
    UNASSIGNED: Increases in mean fluorescence intensity (p = 0.0004) and percentage of positively stained area (p = 0.00008) with CHP were detected in DDD samples compared to the non-DDD samples. Significant correlations were observed between mean fluorescence intensity and percentage of positively stained area for both non-DDD (R = 0.98, p = 5E-8) and DDD (R = 0.79, p = 0.0012) samples. No significant differences were detected between sex and the lumbar disc level subgroups of the non-DDD and DDD groups. Only tissue pathology (non-DDD versus DDD) influenced the measured parameters. No three-way interactions between tissue pathology, sex, and lumbar disc level were observed.
    UNASSIGNED: These findings suggest that AF collagen degradation is greater in DDD samples compared to non-DDD samples, as evidenced by the increased CHP staining. Strong positive correlations between the two measured parameters suggest that when collagen degradation occurs, it is detected by this technique and is widespread throughout the tissue. This study provides new insights into the structural alterations associated with collagen degradation in the AF that occur during DDD.
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  • 文章类型: Journal Article
    背景:外侧腰椎椎间融合术(LLIF)与后路螺钉融合术对于患有退行性脊柱疾病的患者是一种安全有效的治疗方法。虽然LLIF已被证明可以恢复光盘高度,解压缩神经成分,纠正矢状不平衡,改善疼痛评分,该方法需要重新定位患者进行后路椎弓根固定,这需要两个单独的手术。外科技术的发展,导航,并且机器人技术允许在患者处于俯卧位的情况下对LLIF进行单位置方法。这项研究的目的是进行系统评价和荟萃分析,比较俯卧单位置(PSP)LLIF方法与双位置LLIF方法。我们假设PSPLLIF将减少手术时间,并发症发生率,与双位置LLIF程序相比,失血量。
    方法:根据2020年系统评价和荟萃分析指南的首选报告项目进行系统评价。使用关键术语搜索PubMed和Embase数据库:(横向和[体间或“体间”]和腰椎和融合)和(俯卧或单)。根据选择标准,由2位作者(MR和RB)提取和审查结果。从选定的研究中提取患者的人口统计数据,随着外科手术,患者报告,和射线照相结果。使用非标准化平均差或对数比值比进行荟萃分析,置信水平为95%。
    结果:15项研究纳入系统评价,5项研究比较了PSPLLIF与双位置LLIF的荟萃分析。与双位置入路相比,PSPLLIF减少了手术时间和住院时间。尽管估计的失血量没有显着减少。此外,PSPLLIF比双位置LLIF更有效地改善腰椎前凸。节段前凸或骨盆倾斜没有差异。术中并发症无差异,术后并发症,或重新操作。
    结论:PSPLLIF可缩短手术时间和住院时间,与双体位入路相比,并发症或再手术没有相对增加。此外,PSPLLIF相对于双位置LLIF可改善腰椎前凸,这可能会改善功能结局并降低发生相邻节段疾病的风险。
    结论:PSPLLIF的相关手术和术后益处可能会改善脊柱融合术患者的长期预后。
    方法:
    BACKGROUND: Lateral lumbar interbody fusion (LLIF) with posterior screw fusion is a safe and effective treatment for patients suffering from degenerative spine disorders. While LLIF has been shown to restore disc height, decompress neural components, correct sagittal imbalances, and improve pain scores, the approach requires repositioning patients for posterior pedicle fixation, which requires 2 separate surgeries. The evolution of surgical techniques, navigation, and robotics has allowed for a single position approach to LLIF with the patient in the prone position. The purpose of this study was to perform a systematic review and meta-analysis comparing the prone single position (PSP) LLIF approach to the dual position LLIF approach. We hypothesized that PSP LLIF will have a reduced operative time, complication rate, and blood loss compared with the dual position LLIF procedure.
    METHODS: A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. PubMed and Embase databases were searched with key terms: (lateral AND [interbody OR \"inter body\"] AND lumbar AND fusion) AND (prone OR single). Results were extracted and reviewed by 2 authors (MR and RB) per selection criteria. Patient demographics were extracted from the selected studies, along with surgical, patient-reported, and radiographic outcomes. A meta-analysis was performed using an unstandardized mean difference or log odds ratio with a confidence level of 95%.
    RESULTS: Fifteen studies were included in the systematic review and 5 studies compared PSP LLIF to dual position LLIF for meta-analysis. PSP LLIF had a reduced operative time and length of stay compared with the dual position approach, although there was no significant reduction in estimated blood loss. Additionally, PSP LLIF improved lumbar lordosis more effectively than dual position LLIF. There was no difference in segmental lordosis or pelvic tilt. There was no difference in intraoperative complications, postoperative complications, or reoperations.
    CONCLUSIONS: PSP LLIF reduces operative time and length of stay, with no relative increase in complications or reoperations compared with the dual position approach. Additionally, PSP LLIF improves lumbar lordosis relative to dual position LLIF, which may improve functional outcomes and reduce the risk of developing adjacent segment disease.
    CONCLUSIONS: The associated operative and postoperative benefits of PSP LLIF may improve long-term outcomes of patients undergoing spinal fusion.
    METHODS:
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  • 文章类型: Journal Article
    目标:慢性下腰痛(CLBP),影响了高达58%的人口,常源于椎间盘退变。尽管磁共振成像(MRI)通常用于诊断,由于频繁的无症状发现,在确定疼痛来源方面出现了挑战.单光子发射断层扫描(SPECT)与计算机断层扫描(CT)集成提供了一种有前途的方法,增强敏感性和特异性。
    方法:在这项回顾性研究中,从2016年到2022年,我们对符合特定标准的193例患者进行了SPECT/CT成像.我们将SPECT/CT结果与腰椎MRI结果相关联,利用Pfirrmann和Rajasekaran分类进行椎间盘退变和终板损伤评估。Logistic回归分析校正了年龄和性别评估的关联。
    结果:在评估的965个脊柱水平中,SPECT/CT阳性与较高的Pfirrmann等级和Rajasekaran终板分类密切相关。值得注意的是,MRI上的Modic变化与SPECT/CT阳性无关。在Modic变化呈阳性的老年患者中观察到显着的关联,Pfirrmann成绩,和Rajasekaran分类。
    结论:这项综合研究,同类中最大的,在SPECT/CT阳性与晚期腰椎退行性改变之间建立了重要联系。较高的Pfirrmann等级和增加的Rajasekaran终板损伤表明与SPECT/CT阳性具有实质性相关性。值得注意的是,Modic变化没有表现出这种关联。我们的发现强调了SPECT/CT在确定退行性脊柱疾病中疼痛发生器的潜力,为未来的干预提供有价值的见解。
    OBJECTIVE: Chronic low back pain (CLBP), affecting up to 58% of the population, often stems from intervertebral disc degeneration. Although magnetic resonance imaging (MRI) is commonly used for diagnostics, challenges arise in pinpointing pain sources due to frequent asymptomatic findings. Single-photon emission tomography (SPECT) integrated with computed tomography (CT) offers a promising approach, enhancing sensitivity and specificity.
    METHODS: In this retrospective study, spanning 2016 to 2022, SPECT/CT imaging was performed on 193 patients meeting specific criteria. We correlated SPECT/CT findings with lumbar MRI results, utilizing Pfirrmann and Rajasekaran classifications for disc degeneration and endplate damage assessment. Logistic regression analysis adjusted for age and sex evaluated associations.
    RESULTS: Of 965 spinal levels assessed, SPECT/CT positivity strongly correlated with higher Pfirrmann grades and Rajasekaran endplate classifications. Notably, Modic changes on MRI displayed a non-significant relationship with SPECT/CT positivity. Significant associations were observed in older patients with positive Modic changes, Pfirrmann grades, and Rajasekaran classifications.
    CONCLUSIONS: This comprehensive study, the largest of its kind, establishes a significant link between SPECT/CT positivity and advanced lumbar degenerative changes. Higher Pfirrmann grades and increased Rajasekaran endplate damage demonstrated substantial correlations with SPECT/CT positivity. Notably, Modic changes did not exhibit such association. Our findings underscore the potential of SPECT/CT in identifying pain generators in degenerative spinal conditions, offering valuable insights for future interventions.
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  • 文章类型: Journal Article
    Modic变化(MC)是椎骨的骨髓病变,可以通过靠近退变椎间盘的磁共振成像(MRI)检测到。由它们在T1和T2加权图像上的外观定义,有三种可互换类型:MC1、MC2和MC3。MRI诊断的观察者间变异性很高,因此,补充MRI以促进诊断和随访的诊断血清生物标志物将具有重要价值.
    我们使用了一种高度敏感和可重复的蛋白质组学方法:DIA/SWATH-MS在1966年北芬兰出生队列的一个子集中寻找血清生物标志物。分别,我们用一种名为V-Plex的基于ELISA的方法测定了一组与炎症和血管生成有关的因子,以确认之前发表的一些潜在的生物标志物.
    我们发现DIA/SWATH-MS检测到的蛋白质的血清浓度与MC的存在没有关联,与MC病变的大小也无相关性。我们没有发现用V-Plex测量的因素与MC的存在或其大小之间的任何关联。
    总之,我们的研究表明,在血清中不易发现一种稳健且普遍可用的促进MC诊断的生物标志物.
    UNASSIGNED: Modic changes (MC) are bone marrow lesions of vertebral bones, which can be detected with magnetic resonance imaging (MRI) adjacent to degenerated intervertebral discs. Defined by their appearance on T1 and T2 weighted images, there are three interconvertible types: MC1, MC2, and MC3. The inter-observer variability of the MRI diagnosis is high, therefore a diagnostic serum biomarker complementing the MRI to facilitate diagnosis and follow-up would be of great value.
    UNASSIGNED: We used a highly sensitive and reproducible proteomics approach: DIA/SWATH-MS to find serum biomarkers in a subset of the Northern Finland Birth Cohort 1966. Separately, we measured a panel of factors involved in inflammation and angiogenesis to confirm some potential biomarkers published before with an ELISA-based method called V-Plex.
    UNASSIGNED: We found neither an association between the serum concentrations of the proteins detected with DIA/SWATH-MS with the presence of MC, nor a correlation with the size of the MC lesions. We did not find any association between the factors measured with the V-Plex and the presence of MC or their size.
    UNASSIGNED: Altogether, our study suggests that a robust and generally usable biomarker to facilitate the diagnosis of MC cannot readily be found in serum.
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  • 文章类型: Journal Article
    一起,下背部和颈部疼痛是全球获得性残疾的主要原因之一,在过去25年中经历了显著增加。与人口老龄化和慢性病的增加并行,预计这一趋势只会加剧全球负担。在颈部疼痛的背景下,这种症状通常是颈椎间盘退行性疾病(DDD)的表现。传统上,与DDD相关的多级颈部疼痛对物理和药物治疗均具有顽固性,可以通过称为颈椎全切术的方法进行治疗。目前,颈椎全切术有很多味道;然而,首要目标是通过采用现代前路手术切除产生疼痛的椎间盘.在这次审查中,我们将简要详述DDD背后的病理生理机制,概述前路手术的发展,并讨论所述病理学的治疗选择的现状。此外,这篇综述还将增加目前围绕更新适应症的文献,外科技术,和患者的结果与颈椎全切术有关。最后,我们的讨论结束时,通过引入“跳过椎体切除术”和可分散的网状笼,突出了颈椎椎体切除术的未来方向。
    Together, lower back and neck pain are among the leading causes of acquired disability worldwide and have experienced a marked increase over the past 25 years. Paralleled with the increasing aging population and the rise in chronic disease, this trend is only predicted to contribute to the growing global burden. In the context of cervical neck pain, this symptom is most often a manifestation of cervical degenerative disc disease (DDD). Traditionally, multilevel neck pain related to DDD that is recalcitrant to both physical and medical therapy can be treated with a procedure known as cervical corpectomy. Presently, there are many flavors of cervical corpectomy; however, the overarching goal is the removal of the pain-generating disc via the employment of the modern anterior approach. In this review, we will briefly detail the pathophysiological mechanism behind DDD, overview the development of the anterior approach, and discuss the current state of treatment options for said pathology. Furthermore, this review will also add to the current body of literature surrounding updated indications, surgical techniques, and patient outcomes related to cervical corpectomy. Finally, our discussion ends with highlighting the future direction of cervical corpectomy through the introduction of the \"skip corpectomy\" and distractable mesh cages.
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  • 文章类型: Journal Article
    京尼平聚合物是自形成的拉伸载荷低聚物,来源于栀子果实,与胶原蛋白上的胺共价键合。1998年首次设想了用于降解脊柱椎间盘的京尼平低聚物的非离散原位形成网的潜在治疗机械益处。二十多年来,许多研究已经证明了这种注射剂的直接机械效应,环状聚合物网状物包括对慢性或复发性椎间盘源性下腰痛的临床结局的早期证明。这篇文献综述集中在研究尸体动物和人类椎间盘的机械效应的文章,生化作用机制研究,文章描述了机械退化在椎间盘退行性疾病发病机理中的作用,最初的临床结果和描述当前椎间盘源性下腰痛治疗算法的文章。根据这些结果,讨论了与这种新型可注射聚合物基治疗策略的功能相一致的临床适应症.旨在针对生物受限组织中的机械缺陷的新型基于纳米级材料的解决方案的这篇综述可能会为脊柱疾病和类似的具有挑战性的肌肉骨骼疾病的其他创新提供有用的例子。
    Genipin polymers are self-forming tensile-load-carrying oligomers, derived from the gardenia fruit, that covalently bond to amines on collagen. The potential therapeutic mechanical benefits of a non-discrete in situ forming mesh of genipin oligomers for degraded spinal discs were first conceived in 1998. Over more than two decades, numerous studies have demonstrated the immediate mechanical effects of this injectable, intra-annular polymeric mesh including an early demonstration of an effect on clinical outcomes for chronic or recurrent discogenic low back pain. This literature review focused on articles investigating mechanical effects in cadaveric animal and human spinal discs, biochemical mechanism of action studies, articles describing the role of mechanical degradation in the pathogenesis of degenerative disc disease, initial clinical outcomes and articles describing current discogenic low back pain treatment algorithms. On the basis of these results, clinical indications that align with the capabilities of this novel injectable polymer-based treatment strategy are discussed. It is intended that this review of a novel nano-scale material-based solution for mechanical deficiencies in biologically limited tissues may provide a helpful example for other innovations in spinal diseases and similarly challenging musculoskeletal disorders.
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  • 文章类型: Journal Article
    背景:来自椎间盘组织的祖细胞在临床前研究中表现出免疫调节和再生特性。我们报告了美国食品和药物管理局批准的这些细胞用于治疗症状性椎间盘退行性疾病的临床试验的安全性和有效性结果。
    方法:60例有症状的单级腰椎间盘退变性疾病患者(平均年龄37.9岁,60%的男性)被纳入随机分组,双盲,13个临床地点的安慰剂对照I期/II期研究。他们被随机接受低剂量细胞的单次椎间盘内注射(N=20),高剂量细胞(N=20),单独车辆(N=10),或安慰剂(N=10)。主要终点是在52周时平均视觉模拟评分(VAS)疼痛改善>30%。对椎间盘体积进行放射学评估。不良事件(AE),不管它们是否与治疗有关,被报道。在基线和治疗后4、12、26、52、78和104周评估患者。
    结果:在第52周,高剂量组的平均VAS百分比从基线降低(-62.8%,P=0.0005),达到腰背痛改善>30%的终点;平均变化也显著大于20点下降的最小临床重要差异(-42.8,P=0.001).这种临床改善在第104周保持。车辆组的VAS下降幅度较小(-52.8%,P=0.044),而低剂量组和安慰剂组没有显着改善。只有高剂量组椎间盘体积有显著变化,52周时平均增加249.0mm3(P=0.028),104周时平均增加402.1mm3(P=0.028)。少数患者(18.3%)报告了严重的AE。总的来说,6.7%的患者出现严重不良事件,所有在载体(n=1)或安慰剂(n=3)组中,没有治疗相关。
    结论:大剂量同种异体椎间盘祖细胞产生了统计学上显著的,单次椎间盘内注射后1年,背痛和椎间盘体积有临床意义的改善,且安全性和耐受性良好.这些改善在注射后2年保持。
    方法:
    背景:NCT03347708-评估可注射椎间盘细胞疗法的安全性和初步疗效的研究,症状性腰椎间盘退变的治疗。
    BACKGROUND: Progenitor cells derived from intervertebral disc tissue demonstrated immunomodulatory and regenerative properties in preclinical studies. We report the safety and efficacy results of a US Food and Drug Administration-approved clinical trial of these cells for the treatment of symptomatic degenerative disc disease.
    METHODS: Sixty patients with symptomatic single-level lumbar degenerative disc disease (mean age 37.9 years, 60% men) were enrolled in a randomized, double-blinded, placebo-controlled Phase I/Phase II study at 13 clinical sites. They were randomized to receive single intradiscal injections of either low-dose cells (N = 20), high-dose cells (N = 20), vehicle alone (N = 10), or placebo (N = 10). The primary endpoint was mean visual analog scale (VAS) pain improvement >30% at 52 weeks. Disc volume was radiologically assessed. Adverse events (AEs), regardless of whether they were related to treatment, were reported. Patients were assessed at baseline and at 4, 12, 26, 52, 78, and 104 weeks posttreatment.
    RESULTS: At week 52, the high-dose group had a mean VAS percentage decrease from baseline (-62.8%, P = 0.0005), achieving the endpoint of back pain improvement >30%; the mean change was also significantly greater than the minimal clinically important difference of a 20-point decrease (-42.8, P = 0.001). This clinical improvement was maintained at week 104. The vehicle group had a smaller significant decrease in VAS (-52.8%, P = 0.044), while the low-dose and placebo groups showed nonsignificant improvements. Only the high-dose group had a significant change in disc volume, with mean increases of 249.0 mm3 (P = 0.028) at 52 weeks and 402.1 mm3 (P = 0.028) at 104 weeks. A minority of patients (18.3%) reported AEs that were severe. Overall, 6.7% of patients experienced serious AEs, all in the vehicle (n = 1) or placebo (n = 3) groups, none treatment related.
    CONCLUSIONS: High-dose allogeneic disc progenitor cells produced statistically significant, clinically meaningful improvements in back pain and disc volume at 1 year following a single intradiscal injection and were safe and well tolerated. These improvements were maintained at 2 years post-injection.
    METHODS:
    BACKGROUND: NCT03347708-Study to Evaluate the Safety and Preliminary Efficacy of Injectable Disc Cell Therapy, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration.
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  • 文章类型: Journal Article
    腰椎融合术是一种常见的手术,并发症和翻修手术率相对较高。腰椎间盘置换较不常见,但可能比脊柱融合有一些好处。这项荟萃分析旨在比较腰椎间盘置换(LDR)与椎间融合术(IBF)的结果,评估其治疗腰椎DDD的相对安全性和有效性。
    PubMed,科克伦,和谷歌学者(第1-2页)的搜索时间一直到2024年2月。研究结果包括手术室(OR)时间,估计失血量(EBL),住院时间(LOS),并发症,重新操作,Oswestry残疾指数(ODI),背痛,和腿部疼痛。
    本荟萃分析包括10项研究,其中六项是随机对照试验,三个是回顾性研究,其中一项是前瞻性研究。共纳入1720例患者,1034例接受LDR,686例接受IBF。OR时间无统计学差异,EBL,或LDR和IBF组之间的LOS。分析还显示并发症发生率没有显着差异,重新操作,两组之间的腿部疼痛。然而,与IBF组相比,LDR组显示出平均背痛的统计学显著减轻(p=0.04).
    LDR和IBF程序在管理CLBP方面提供了相似的结果,考虑或时间,EBL,LOS,并发症发生率,重新操作,腿部疼痛,LDR的背痛改善略有优势。这项研究支持使用这两种方法来管理退行性脊柱疾病。
    UNASSIGNED: Lumbar spinal fusion is a commonly performed operation with relatively high complication and revision surgery rates. Lumbar disc replacement is less commonly performed but may have some benefits over spinal fusion. This meta-analysis aims to compare the outcomes of lumbar disc replacement (LDR) versus interbody fusion (IBF), assessing their comparative safety and effectiveness in treating lumbar DDD.
    UNASSIGNED: PubMed, Cochrane, and Google Scholar (pages 1-2) were searched up until February 2024. The studied outcomes included operative room (OR) time, estimated blood loss (EBL), length of hospital stay (LOS), complications, reoperations, Oswestry Disability Index (ODI), back pain, and leg pain.
    UNASSIGNED: Ten studies were included in this meta-analysis, of which six were randomized controlled trials, three were retrospective studies, and one was a prospective study. A total of 1720 patients were included, with 1034 undergoing LDR and 686 undergoing IBF. No statistically significant differences were observed in OR time, EBL, or LOS between the LDR and IBF groups. The analysis also showed no significant differences in the rates of complications, reoperations, and leg pain between the two groups. However, the LDR group demonstrated a statistically significant reduction in mean back pain (p=0.04) compared to the IBF group.
    UNASSIGNED: Both LDR and IBF procedures offer similar results in managing CLBP, considering OR time, EBL, LOS, complication rates, reoperations, and leg pain, with slight superiority of back pain improvement in LDR. This study supports the use of both procedures in managing degenerative spinal disease.
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