血液金属离子水平对于金属碎屑不良反应的检测并不实用：系统评价和荟萃分析。
Blood metal ion levels are not a useful test for adverse reactions to metal debris: A systematic review and meta-analysis.
机构信息
University of Ottawa, The Ottawa Hospital, 501 Smyth Road, Ottawa, Ontario, Canada.
Rijnstate Hospital, Arnhem, The Netherlands.
出版信息
Bone Joint Res. 2016 Sep;5(9):379-86. doi: 10.1302/2046-3758.59.BJR-2016-0027.R1.
OBJECTIVES
Alarm over the reported high failure rates for metal-on-metal (MoM) hip implants as well as their potential for locally aggressive Adverse Reactions to Metal Debris (ARMDs) has prompted government agencies, internationally, to recommend the monitoring of patients with MoM hip implants. Some have advised that a blood ion level >7 µg/L indicates potential for ARMDs. We report a systematic review and meta-analysis of the performance of metal ion testing for ARMDs.
METHODS
We searched MEDLINE and EMBASE to identify articles from which it was possible to reconstruct a 2 × 2 table. Two readers independently reviewed all articles and extracted data using explicit criteria. We computed a summary receiver operating curve using a Bayesian random-effects hierarchical model.
RESULTS
Our literature search returned 575 unique articles; only six met inclusion criteria defined a priori. The discriminative capacity of ion tests was homogeneous across studies but that there was substantial cut-point heterogeneity. Our best estimate of the "true" area under curve (AUC) for metal ion testing is 0.615, with a 95% credible interval of 0.480 to 0.735, thus we can state that the probability that metal ion testing is actually clinically useful with an AUC ≥ 0.75 is 1.7%.
CONCLUSION
Metal ion levels are not useful as a screening test for identifying high risk patients because ion testing will either lead to a large burden of false positive patients, or otherwise marginally modify the pre-test probability. With the availability of more accurate non-invasive tests, we did not find any evidence for using blood ion levels to diagnose symptomatic patients.Cite this article: M. Pahuta, J. M. Smolders, J. L. van Susante, J. Peck, P. R. Kim, P. E. Beaule. Blood metal ion levels are not a useful test for adverse reactions to metal debris: a systematic review and meta-analysis. Bone Joint Res 2016;5:379-386. DOI: 10.1302/2046-3758.59.BJR-2016-0027.R1.
目的
由于金属对金属（MoM）髋关节植入物的高失败率及其对金属碎屑的局部侵袭性不良反应（ARMDs）的潜在风险，引起了国际政府机构的关注，建议对 MoM 髋关节植入物的患者进行监测。一些人建议，血液离子水平>7μg/L 表明存在 ARMDs 的可能性。我们报告了一项针对 ARMDs 的金属离子检测性能的系统评价和荟萃分析。
方法
我们检索了 MEDLINE 和 EMBASE，以从其中检索出有可能重建 2×2 表的文章。两位读者独立审查了所有文章，并使用明确的标准提取数据。我们使用贝叶斯随机效应分层模型计算了综合接收者操作曲线。
结果
我们的文献检索返回了 575 篇独特的文章；只有 6 篇符合事先定义的纳入标准。离子试验的鉴别能力在研究之间是同质的，但存在明显的切点异质性。我们对金属离子检测的“真实”曲线下面积（AUC）的最佳估计值为 0.615，95%可信区间为 0.480 至 0.735，因此我们可以说金属离子检测实际上具有临床用途的概率 AUC≥0.75 为 1.7%。
结论
金属离子水平不能作为识别高危患者的筛查试验，因为离子检测要么导致大量假阳性患者，要么对术前概率的影响微乎其微。随着更准确的非侵入性检测的出现，我们没有发现任何证据表明使用血液离子水平来诊断有症状的患者。引用本文：M. Pahuta、J. M. Smolders、J. L. van Susante、J. Peck、P. R. Kim、P. E. Beaule。血液金属离子水平不能用于诊断金属碎屑不良反应：系统评价和荟萃分析。骨与关节研究 2016;5:379-386。DOI：10.1302/2046-3758.59.BJR-2016-0027.R1.
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