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椎体成形术“假手术”试验 2009 年发表后,VCF 患者的死亡率是否更高?

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

机构信息

Exponent, Inc., 3440 Market St, Suite 600, Philadelphia, PA, USA.

Oklahoma Spine, Edmond, OK, USA.

出版信息

Osteoporos Int. 2018 Feb;29(2):375-383. doi: 10.1007/s00198-017-4281-z. Epub 2017 Oct 24.

DOI:10.1007/s00198-017-4281-z
PMID:29063215
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6394540/
Abstract

UNLABELLED

The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients.

INTRODUCTION

BKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients.

METHODS

BKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors.

RESULTS

The cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort.

CONCLUSIONS

Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

摘要

未加标签

2009 年后的 5 年期间,椎体增强量急剧减少,与椎体压缩性骨折(VCF)患者的死亡率升高有关。VCF 诊断后 10 年的死亡率为 85.1%,球囊扩张椎体后凸成形术(BKP)和椎体成形术(VP)患者的死亡率较低。

引言

BKP 和 VP 与非手术治疗(NSM)相比,与较低的死亡率风险相关。2009 年发表的 VP 与假手术对照试验引发了其疗效的争议,导致转诊量减少。我们假设,BKP/VP 利用率的降低将导致 VCF 患者的死亡风险增加。

方法

在 100%美国医疗保险数据集(2005-2014 年)中评估 VCF 患者的 BKP/VP 使用率。采用 Kaplan-Meier 法分析生存率和发病率,并采用 Cox 回归比较 NSM、BKP 和 VP 之间的差异,同时通过倾向评分和各种因素进行调整。

结果

该队列包括 261756 例 BKP(12.6%)和 117232 例 VP(5.6%)患者,占 2005 年 VCF 患者人群的 20%,在 2007-2008 年达到峰值的 24%,并在 2014 年降至 14%。与 2005-2009 年相比,2010-2014 年 VCF 患者的死亡率风险增加了 4%(95%CI,3-4%;p<0.001)。整个队列的 10 年死亡率为 85.1%。BKP 和 VP 队列的 10 年死亡率分别比 NSM 队列低 19%(95%CI,19-19%;p<0.001)和 7%(95%CI,7-8%;p<0.001)。与 VP 队列相比,BKP 队列的 10 年死亡率风险低 13%(95%CI,12-13%;p<0.001)。

结论

2009 年 VP 出版物后的治疗模式变化导致了较少的增强程序。反过来,2009 年后的 5 年期间与 VCF 患者的死亡率升高有关。这为我们了解治疗模式变化及其相关的死亡率风险提供了线索。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/1e1a51eaaa8c/198_2017_4281_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/ddf615485961/198_2017_4281_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/fae0394fda52/198_2017_4281_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/a8361e822f42/198_2017_4281_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/1e1a51eaaa8c/198_2017_4281_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/ddf615485961/198_2017_4281_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/fae0394fda52/198_2017_4281_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/a8361e822f42/198_2017_4281_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a778/6394540/1e1a51eaaa8c/198_2017_4281_Fig4_HTML.jpg

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