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经皮椎体成形术,一种用于椎间盘减压的微创手术:已发表临床研究的系统评价和荟萃分析。

Nucleoplasty, a minimally invasive procedure for disc decompression: a systematic review and meta-analysis of published clinical studies.

作者信息

Eichen Philipp Maximilian, Achilles Nils, Konig Volker, Mosges Ralph, Hellmich Martin, Himpe Bastian, Kirchner Rainer

机构信息

Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University Hospital of Cologne, Germany.

出版信息

Pain Physician. 2014 Mar-Apr;17(2):E149-73.

Abstract

BACKGROUND

Nucleoplasty, based on Coblation® technology, is a minimally invasive procedure used to decompress herniated discs. Reviews to date--exclusively systematic reviews--recommend nucleoplasty for treating chronic back pain, although with the restriction of limited to fair evidence. We therefore aimed to summarize and interpret our calculated results, where possible comprehensively and quantitatively, using statistical methods in the context of a meta-analysis supplementing a systematic review. In the process, the central question was to statistically determine whether, and to what extent, nucleoplasty can positively affect pain relief and functional mobility as well as lower the complication rate.

OBJECTIVE

Newly published studies made it possible to conduct a meta-analysis of the visual analog scale (VAS), a measuring instrument used to determine pain intensity, and the Oswestry Disability Index (ODI), a scale that reflects the degree of impairment in percent. In addition to having clearly sound evidence for analyzing VAS/NPS data, the present, newly compiled meta-analysis was able to summarize VAS and ODI data quantitatively and to calculate a total complication rate for the first time. It was thereby possible to make a first comparison between nucleoplasty and conservative therapy (including epidural steroid injection).

STUDY DESIGN

This meta-analysis examined all study data published in clinical trials involving the nucleoplasty procedure for plasma disc decompression.

METHODS

A systematic search using the terms nucleoplasty and/or plasma disc decompression was conducted for literature listed in MEDLINE. Twenty-seven eligible studies (22 prospective trials and 5 retrospective trials) were included, and pooled analyses as well as various subgroup analyses (differentiation between cervical and lumbar disc herniations, comparisons with alternative treatments such as epidural steroid injection) were performed based on their data.

RESULTS

Pain decreased from a baseline VAS value of 7.27 to 2.12 (postop/first day), 2.50 (one week), 2.70 (2 weeks), 3.23 (one month), 2.66 (6 weeks), 2.84 (3 months), 3.06 (6 months), 3.03 (12 months), 1.54 (18 months), and 3.69 (24 months) after nucleoplasty. The ODI value (baseline: 58.95) dropped to 28.60 (one week), 29.00 (2 weeks), 23.21 (one month), 30.00 (6 weeks), 18.30 (3 months), 22.54 (6 months), 24.43 (12 months), 12.82 (18 months), and 36.98 (24 months). Compared to baseline, significant pain reduction and improvement in functional mobility after nucleoplasty were observed at every time point. Nucleoplasty showed a total complication rate of 1.5%, with the individual rates being 0.8% for cervical and 1.8% for lumbar nucleoplasty. Nucleoplasty was superior to conservative therapy at every time point and for all 3 included parameters, at some measurement time points even significantly.

CONCLUSIONS

Nucleoplasty reduces pain in the long term and improves patients' functional mobility. It is an effective, low-complication, minimally invasive procedure used to treat disc herniations.

摘要

背景

基于低温等离子消融(Coblation®)技术的髓核成形术是一种用于减轻椎间盘突出症压迫的微创手术。迄今为止的综述——均为系统综述——推荐髓核成形术用于治疗慢性背痛,尽管证据有限。因此,我们旨在通过荟萃分析补充系统综述,尽可能全面和定量地总结并解释我们计算得出的结果,在此过程中,核心问题是从统计学角度确定髓核成形术是否以及在何种程度上能够对缓解疼痛、改善功能活动能力产生积极影响,并降低并发症发生率。

目的

新发表的研究使得对视觉模拟量表(VAS,一种用于确定疼痛强度的测量工具)和Oswestry功能障碍指数(ODI,一种以百分比反映功能障碍程度的量表)进行荟萃分析成为可能。除了拥有用于分析VAS/NPS数据的明确可靠证据外,本次新编制的荟萃分析能够定量总结VAS和ODI数据,并首次计算出总并发症发生率。从而能够首次对髓核成形术与保守治疗(包括硬膜外类固醇注射)进行比较。

研究设计

本荟萃分析检查了所有发表在涉及等离子椎间盘减压髓核成形术临床试验中的研究数据。

方法

使用“髓核成形术”和/或 “等离子椎间盘减压” 等术语对MEDLINE中列出的文献进行系统检索。纳入了27项符合条件的研究(22项前瞻性试验和5项回顾性试验),并根据其数据进行汇总分析以及各种亚组分析(区分颈椎和腰椎间盘突出症,与硬膜外类固醇注射等替代治疗方法进行比较)。

结果

髓核成形术后,疼痛从基线VAS值7.27降至术后/第一天的2.12、一周后的2.50、两周后的2.70、一个月后的3.23、六周后的2.66、三个月后的2.84、六个月后的3.06、十二个月后的3.03、十八个月后的1.54以及二十四个月后的3.69。ODI值(基线:58.95)降至一周后的28.60、两周后的29.00、一个月后的23.21、六周后的30.00、三个月后的18.30、六个月后的22.54、十二个月后的24.43、十八个月后的12.82以及二十四个月后的36.98。与基线相比,在每个时间点均观察到髓核成形术后疼痛显著减轻且功能活动能力得到改善。髓核成形术的总并发症发生率为1.5%,其中颈椎髓核成形术的发生率为0.8%,腰椎髓核成形术的发生率为1.8%。在每个时间点以及所有三个纳入参数方面,髓核成形术均优于保守治疗,在某些测量时间点甚至具有显著优势。

结论

髓核成形术可长期减轻疼痛并改善患者的功能活动能力。它是一种用于治疗椎间盘突出症的有效且低并发症的微创手术。

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