使用或不使用椎弓根螺钉固定的腰椎融合术RCT研究
Lumbar Fusion With and Without Pedicle Screw Fixation Comments on a Prospective, Randomized Study带或不带椎弓根螺钉固定的腰椎融合术(对一项前瞻随机试验的评价)
Study Design.
In this Journal Club review, the study design, conduct, and analysis of Zdeblick’s prospective, randomized trial comparing instrumented and noninstru- mented posterolateral lumbar fusion, “A Prospective, Randomized Study of Lumbar Fusion:
Preliminary Results,” are examined.
研究设计：这篇期刊俱乐部的评价对Zdeblick的一篇随机对照试验进行了比较，其内容是比较器械或不带器械的后外侧腰椎融合术的效果。
Objective
The objective of this paper is to review one of the most frequently cited papers published in Spine, to evaluate and discuss its methods and conclusions, and to understand its significance in light of subsequent research.
Summary of Background Data. At the time of publication (1993), there were no published studies comparing the fusion rates and clinical outcomes of noninstru- mented and instrumented posterolateral lumbar fusion.
目的：本文章目的是对一篇在《脊柱》杂志上发表的，被广泛引用的文章进行评价，评估并讨论其方法和结论，了解其对随后研究的意义。
背景资料总结：在1993年该文章发表时，还没有比较后外侧腰椎融合器械固定与非器械固定之间融合率和临床疗效的相关文章发表。
Methods
The study protocol and methods were critically examined. The results as originally reported and as verified or modified by the reanalysis are discussed in their original context and based on ensuing studies.
方法：研究的程序和方法经过了严格的检查。最初报告的结果和证实的结果以及再分析后改进的结果都根据其原有情况进行了讨论。
Results
The original paper reported a benefit with rigid pedicle screw fixation in both the proportion of patients achieving fusion and clinical outcome in patients with degenerative lumbar disease. The reanalysis demonstrated that the difference between the rigid fixation and noninstrumented groups persisted even after ac- counting for the postrandomization reassignment of patients. Although the difference in clinical outcome between the rigidly instrumented and noninstrumented groups was statistically significant, a nonvalidated, physician-based measure was used. Subgroup analyses of fusion did not reach statistical significance.
Conclusions
This prospective, randomized trial demonstrated that, compared with noninstrumented postero- lateral lumbar fusion, rigid pedicle screw fixation results in an increase in the proportion of patients achieving arthrodesis from 64% to 88%. It is not possible to generalize these results to other patient populations. Subsequent research by
other investigators has generally confirmed the beneficial effect of rigid segmental fixation on
Key words: Journal Club, pedicle screw, lumbar fusion
结果：原文报告经过椎弓根螺钉固定后，无论在获得融合的患者比例还是临床疗效上（退行性腰椎疾病）都显示其对于非椎弓根螺钉固定的优势。再分析显示两组之间的差异在即使进行随机分组后仍然存在。尽管两组在临床疗效上差异有统计学意义，但疗效差异使用的评价方法却是真实性有欠缺的，医生评估的方法。而融合组的亚组之间的分析未有统计学意义。
结论：这项前瞻性，随机研究显示器械组愈合比例由64%增加到88%。其他组不可能得到同样结果。其他研究者 在随后的研究中都证实了牢固节段固定在获得融合上的优点，但在牢固固定与临床疗效之间的存在正相关关系这一问题还有待证实。
[[i] 本帖最后由 daike_ren 于 2008-7-1 12:50 编辑 [/i]] 学习下!支持!!!!!
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