• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

利用制造商和用户设施设备经验数据得出的棘突间撑开器的真实世界不良事件

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data.

作者信息

Aggarwal Nitish, Chow Robert

机构信息

Department of Anesthesiology, Yale New Haven Hospital, New Haven, CT, USA.

出版信息

Anesth Pain Med (Seoul). 2021 Apr;16(2):177-183. doi: 10.17085/apm.20093. Epub 2021 Apr 19.

DOI:10.17085/apm.20093
PMID:33866770
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8107255/
Abstract

BACKGROUND

Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile.

METHODS

A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration.

RESULTS

Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms.

CONCLUSIONS

Further studies such as randomized controlled trials are needed to validate the findings.

摘要

背景

腰椎管狭窄症是一种进行性神经源性间歇性跛行疾病，在保守治疗失败后可通过腰椎减压手术或侵入性较小的棘突间装置进行治疗。常见的棘突间间隔器包括X-Stop、Vertiflex和Coflex，其中X-Stop因不良事件已退出市场。

方法

使用美国食品药品监督管理局维护的制造商和用户设施设备经验（MAUDE）数据库进行不成比例分析，以确定三种棘突间间隔器与报告的不良事件之间是否存在统计学上的显著信号。

结果

在三种棘突间间隔器（Coflex、Vertiflex和X-Stop）中的每一种以及以下不良事件中的每一种中都发现了统计学上的显著信号：骨折、移位和疼痛/症状加重。

结论

需要进一步的研究，如随机对照试验，来验证这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/3aa1264fb10b/apm-20093f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/ffa7a7ee8a73/apm-20093f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/407ecd30bd94/apm-20093f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/3aa1264fb10b/apm-20093f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/ffa7a7ee8a73/apm-20093f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/407ecd30bd94/apm-20093f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f341/8107255/3aa1264fb10b/apm-20093f3.jpg

相似文献

1
Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data.利用制造商和用户设施设备经验数据得出的棘突间撑开器的真实世界不良事件
Anesth Pain Med (Seoul). 2021 Apr;16(2):177-183. doi: 10.17085/apm.20093. Epub 2021 Apr 19.
2
Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.对来自美国食品药品监督管理局制造商和用户设施设备经验数据库的1027份棘突间装置不良事件报告的分析。
Int J Spine Surg. 2024 Sep 26;18(6):667-75. doi: 10.14444/8652.
3
A Comprehensive Review of Novel Interventional Techniques for Chronic Pain: Spinal Stenosis and Degenerative Disc Disease-MILD Percutaneous Image Guided Lumbar Decompression, Vertiflex Interspinous Spacer, MinuteMan G3 Interspinous-Interlaminar Fusion.慢性疼痛新型介入技术的全面综述：腰椎狭窄症和退行性椎间盘疾病——微创经皮影像引导腰椎减压术、Vertiflex 棘突间撑开器、MinuteMan G3 棘突间-椎板间融合术。
Adv Ther. 2021 Sep;38(9):4628-4645. doi: 10.1007/s12325-021-01875-8. Epub 2021 Aug 14.
4
The Use of Vertiflex® Interspinous Spacer Device in Patients With Lumbar Spinal Stenosis and Concurrent Medical Comorbidities.Vertiflex®椎间孔内固定器在腰椎管狭窄症合并内科合并症患者中的应用
Cureus. 2019 Aug 12;11(8):e5374. doi: 10.7759/cureus.5374.
5
Interspinous implants to treat spinal stenosis.用于治疗椎管狭窄的棘突间植入物。
Curr Rev Musculoskelet Med. 2017 Jun;10(2):182-188. doi: 10.1007/s12178-017-9413-8.
6
Lumbar interspinous spacers: a systematic review of clinical and biomechanical evidence.腰椎棘突间撑开器：临床和生物力学证据的系统评价。
Spine (Phila Pa 1976). 2010 Dec 1;35(25):E1499-506. doi: 10.1097/BRS.0b013e3181e9af93.
7
Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial.用于中度腰椎管狭窄继发间歇性神经源性跛行的Superion棘突间撑开器：一项FDA-IDE随机对照关键试验的两年结果
Spine (Phila Pa 1976). 2015 Mar 1;40(5):275-82. doi: 10.1097/BRS.0000000000000735.
8
Cost-effectiveness and Safety of Interspinous Process Decompression (Superion).棘突间减压术（Superion）的成本效益和安全性
Pain Med. 2019 Dec 1;20(Suppl 2):S2-S8. doi: 10.1093/pm/pnz245.
9
Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up.用于腰椎管狭窄症和退行性椎间盘疾病的棘突间撑开减压术（X-STOP）：一项至少随访3年的多中心研究。
Clin Neurol Neurosurg. 2014 Sep;124:166-74. doi: 10.1016/j.clineuro.2014.07.004. Epub 2014 Jul 14.
10
Interspinous Process Decompression With The Superion Spacer For Lumbar Spinal Stenosis: Real-World Experience From A Device Registry.使用Superion椎间融合器进行棘突间减压治疗腰椎管狭窄症：来自器械注册库的真实世界经验
Med Devices (Auckl). 2019 Oct 3;12:423-427. doi: 10.2147/MDER.S220431. eCollection 2019.

引用本文的文献

1
Complications and radiographic changes after implantation of interspinous process devices: average eight-year follow-up.棘突间装置植入后的并发症和影像学改变：平均八年随访。
BMC Musculoskelet Disord. 2023 Aug 23;24(1):667. doi: 10.1186/s12891-023-06798-9.
2
Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis.不同棘突间装置治疗腰椎管狭窄症的生物力学比较：有限元分析。
BMC Musculoskelet Disord. 2022 Jun 17;23(1):585. doi: 10.1186/s12891-022-05543-y.

本文引用的文献

1
Pyoderma gangrenosum adverse event with Rituximab use: A postmarketing pharmacovigilance analysis.使用利妥昔单抗出现坏疽性脓皮病不良事件：一项上市后药物警戒分析。
Dermatol Ther. 2020 Mar;33(2):e13221. doi: 10.1111/dth.13221. Epub 2020 Jan 17.
2
The Use of Vertiflex® Interspinous Spacer Device in Patients With Lumbar Spinal Stenosis and Concurrent Medical Comorbidities.Vertiflex®椎间孔内固定器在腰椎管狭窄症合并内科合并症患者中的应用
Cureus. 2019 Aug 12;11(8):e5374. doi: 10.7759/cureus.5374.
3
The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment.
《MIST指南：腰椎管狭窄症微创脊柱治疗共识组指南》
Pain Pract. 2019 Mar;19(3):250-274. doi: 10.1111/papr.12744. Epub 2018 Dec 2.
4
Quantitative Methods for the Identification of Signals for Individual Case Safety Reports in India.印度个体病例安全报告信号识别的定量方法
Ther Innov Regul Sci. 2015 Nov;49(6):898-902. doi: 10.1177/2168479015589822.
5
Comparative effectiveness and safety of posterior lumbar interbody fusion, Coflex, Wallis, and X-stop for lumbar degenerative diseases: A systematic review and network meta-analysis.后路腰椎椎间融合术、Coflex、Wallis和X-stop治疗腰椎退行性疾病的比较有效性和安全性：一项系统评价和网状Meta分析
Clin Neurol Neurosurg. 2018 Sep;172:74-81. doi: 10.1016/j.clineuro.2018.06.030. Epub 2018 Jun 30.
6
Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial.用于中度腰椎管狭窄继发间歇性神经源性跛行的Superion棘突间撑开器：一项FDA-IDE随机对照关键试验的两年结果
Spine (Phila Pa 1976). 2015 Mar 1;40(5):275-82. doi: 10.1097/BRS.0000000000000735.
7
Complications in lumbar spine surgery: A retrospective analysis.腰椎手术并发症：一项回顾性分析。
Indian J Orthop. 2013 Jul;47(4):340-5. doi: 10.4103/0019-5413.114909.
8
Omeprazole- and esomeprazole-associated hypomagnesaemia: data mining of the public version of the FDA Adverse Event Reporting System.奥美拉唑和埃索美拉唑相关低镁血症：FDA 不良事件报告系统公开版本的数据挖掘。
Int J Med Sci. 2012;9(5):322-6. doi: 10.7150/ijms.4397. Epub 2012 Jun 13.
9
Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer.使用Superion棘突间撑开器对中度腰椎管狭窄症进行微创治疗。
Open Orthop J. 2011;5:361-7. doi: 10.2174/1874325001105010361. Epub 2011 Oct 14.
10
Dynamic interspinous process stabilization: review of complications associated with the X-Stop device.动态棘突间稳定化：X-Stop 装置相关并发症的综述。
Neurosurg Focus. 2010 Jun;28(6):E8. doi: 10.3171/2010.3.FOCUS1047.