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2018 年人工髋关节和膝关节感染定义:基于循证和验证的标准。

The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria.

机构信息

Rothman Institute, Thomas Jefferson University, Philadelphia, PA.

Cleveland Clinic, Cleveland, OH.

出版信息

J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.

Abstract

BACKGROUND

The introduction of the Musculoskeletal Infection Society (MSIS) criteria for periprosthetic joint infection (PJI) in 2011 resulted in improvements in diagnostic confidence and research collaboration. The emergence of new diagnostic tests and the lessons we have learned from the past 7 years using the MSIS definition, prompted us to develop an evidence-based and validated updated version of the criteria.

METHODS

This multi-institutional study of patients undergoing revision total joint arthroplasty was conducted at 3 academic centers. For the development of the new diagnostic criteria, PJI and aseptic patient cohorts were stringently defined: PJI cases were defined using only major criteria from the MSIS definition (n = 684) and aseptic cases underwent one-stage revision for a noninfective indication and did not fail within 2 years (n = 820). Serum C-reactive protein (CRP), D-dimer, erythrocyte sedimentation rate were investigated, as well as synovial white blood cell count, polymorphonuclear percentage, leukocyte esterase, alpha-defensin, and synovial CRP. Intraoperative findings included frozen section, presence of purulence, and isolation of a pathogen by culture. A stepwise approach using random forest analysis and multivariate regression was used to generate relative weights for each diagnostic marker. Preoperative and intraoperative definitions were created based on beta coefficients. The new definition was then validated on an external cohort of 222 patients with PJI who subsequently failed with reinfection and 200 aseptic patients. The performance of the new criteria was compared to the established MSIS and the prior International Consensus Meeting definitions.

RESULTS

Two positive cultures or the presence of a sinus tract were considered as major criteria and diagnostic of PJI. The calculated weights of an elevated serum CRP (>1 mg/dL), D-dimer (>860 ng/mL), and erythrocyte sedimentation rate (>30 mm/h) were 2, 2, and 1 points, respectively. Furthermore, elevated synovial fluid white blood cell count (>3000 cells/μL), alpha-defensin (signal-to-cutoff ratio >1), leukocyte esterase (++), polymorphonuclear percentage (>80%), and synovial CRP (>6.9 mg/L) received 3, 3, 3, 2, and 1 points, respectively. Patients with an aggregate score of greater than or equal to 6 were considered infected, while a score between 2 and 5 required the inclusion of intraoperative findings for confirming or refuting the diagnosis. Intraoperative findings of positive histology, purulence, and single positive culture were assigned 3, 3, and 2 points, respectively. Combined with the preoperative score, a total of greater than or equal to 6 was considered infected, a score between 4 and 5 was inconclusive, and a score of 3 or less was not infected. The new criteria demonstrated a higher sensitivity of 97.7% compared to the MSIS (79.3%) and International Consensus Meeting definition (86.9%), with a similar specificity of 99.5%.

CONCLUSION

This study offers an evidence-based definition for diagnosing hip and knee PJI, which has shown excellent performance on formal external validation.

摘要

背景

2011 年,矫形感染协会(MSIS)引入了假体周围关节感染(PJI)的诊断标准,这提高了诊断的准确性和研究协作能力。新的诊断检测方法的出现,以及我们在过去 7 年中使用 MSIS 定义所获得的经验教训,促使我们开发了一个基于证据并经过验证的标准更新版本。

方法

本研究为多机构研究,纳入了在 3 家学术中心接受翻修全关节置换术的患者。为了制定新的诊断标准,我们严格定义了 PJI 和无菌患者队列:PJI 病例仅使用 MSIS 定义中的主要标准进行定义(n=684),无菌病例接受一期翻修治疗非感染性疾病,且 2 年内未失败(n=820)。我们研究了血清 C 反应蛋白(CRP)、D-二聚体、红细胞沉降率,以及滑膜白细胞计数、中性粒细胞百分比、白细胞酯酶、α-防御素和滑膜 CRP。术中发现包括冰冻切片、脓性分泌物和培养物中病原体的分离。使用随机森林分析和多元回归的逐步方法,为每个诊断标志物生成相对权重。基于β系数创建了术前和术中定义。然后,将新定义应用于 222 例随后因再感染而失败的 PJI 患者和 200 例无菌患者的外部队列进行验证。比较了新的标准与既定的 MSIS 和先前的国际共识会议定义的性能。

结果

2 次阳性培养或窦道存在被视为主要标准,可诊断为 PJI。血清 CRP(>1mg/dL)、D-二聚体(>860ng/mL)和红细胞沉降率(>30mm/h)升高的计算权重分别为 2、2 和 1 分。此外,滑膜液白细胞计数升高(>3000 个/μL)、α-防御素(信号-截距比>1)、白细胞酯酶(++)、中性粒细胞百分比升高(>80%)和滑膜 CRP(>6.9mg/L)的权重分别为 3、3、3、2 和 1 分。总分大于或等于 6 分的患者被认为感染,2 至 5 分的患者需要结合术中发现来确认或排除诊断。阳性组织学、脓性分泌物和单阳性培养的术中发现分别赋值 3、3 和 2 分。结合术前评分,总分大于或等于 6 分被认为感染,4 至 5 分结果不确定,3 分或更低则认为未感染。新的标准表现出 97.7%的高敏感性,高于 MSIS(79.3%)和国际共识会议定义(86.9%),特异性相似,为 99.5%。

结论

本研究提供了一个基于证据的髋关节和膝关节 PJI 诊断定义,在正式的外部验证中表现出了优异的性能。

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