Department of Infectious Disease, Cleveland Clinic, Cleveland, Ohio, USA.
Department of Infectious Disease, Cleveland Clinic, Cleveland, Ohio, USA
J Clin Microbiol. 2020 Feb 24;58(3). doi: 10.1128/JCM.01764-19.
The addition of toxin enzyme immunoassay (EIA) to nucleic acid amplification tests, including PCR, creates challenges in the diagnosis and management of infection (CDI). There are limited data in large cohorts, with discordant results, that is, PCR-positive/EIA-negative (PCR/EIA) results. We conducted a retrospective cohort study on all PCR/EIA adult inpatients and assessed CDI-related complications and clinical failure. We identified 240 individuals. Twenty-three (9.6%) patients experienced a CDI-related complication, including 2 cases of megacolon, 1 colectomy, and 22 intensive care unit (ICU) admissions. In multivariable logistic regression analyses, baseline severe disease by Infectious Diseases Society of America (IDSA) criteria (odds ratio [OR], 5.84; 95% confidence interval [CI], 1.88 to 18.1; = 0.002), baseline fulminant colitis (OR, 84.7; 95% CI, 14.3 to 500; < 0.001), fever of >38.5°C (OR, 4.61; 95% CI, 1.42 to 15.0; = 0.011), and proton pump inhibitor (PPI) use (OR, 3.50; 95% CI, 1.19 to 10.3; = 0.023) were associated with increased odds of CDI-related complications. For 67 PCR/EIA patients who did not receive complete treatment, clinical failure was observed in 10 (15%) patients. A comparison of PCR/EIA patients who received complete treatment to all 112 PCR/EIA patients showed no differences in CDI-related complications (11% and 13% for PCR/EIA and PCR/EIA patients, respectively), 60-day all-cause mortality (17% and 18% for PCR/EIA and PCR/EIA patients, respectively), or recurrent CDI (7% and 9% for PCR/EIA and PCR/EIA patients, respectively). Predictors of CDI-attributable complications among PCR/EIA patients include baseline severe disease by IDSA criteria, baseline fulminant colitis, and fever of >38.5°C. Identifying the subgroup of PCR/EIA patients who could have true disease, and therefore allowing them to be targeted for treatment, is critical.
毒素酶免疫分析（EIA）的加入到核酸扩增检测，包括 PCR，给感染（CDI）的诊断和管理带来了挑战。在大型队列中，数据有限，结果不一致，即 PCR 阳性/EIA 阴性（PCR/EIA）结果。我们对所有 PCR/EIA 成年住院患者进行了回顾性队列研究，并评估了 CDI 相关并发症和临床失败情况。我们确定了 240 名个体。23 名（9.6%）患者发生 CDI 相关并发症，包括 2 例巨结肠、1 例结肠切除术和 22 例 ICU 入院。在多变量逻辑回归分析中，基线时按传染病学会（IDSA）标准的严重疾病（比值比 [OR]，5.84；95%置信区间 [CI]，1.88 至 18.1； = 0.002）、基线暴发性结肠炎（OR，84.7；95%CI，14.3 至 500； < 0.001）、体温>38.5°C（OR，4.61；95%CI，1.42 至 15.0； = 0.011）和质子泵抑制剂（PPI）使用（OR，3.50；95%CI，1.19 至 10.3； = 0.023）与 CDI 相关并发症的几率增加相关。对于 67 名未接受完整治疗的 PCR/EIA 患者，观察到 10 名（15%）患者临床失败。对接受完整治疗的 PCR/EIA 患者与所有 112 名 PCR/EIA 患者进行比较，两组间 CDI 相关并发症（PCR/EIA 患者为 11%和 13%，PCR/EIA 患者为 11%和 13%）、60 天全因死亡率（PCR/EIA 患者为 17%和 18%，PCR/EIA 患者为 17%和 18%）或复发性 CDI（PCR/EIA 患者为 7%和 9%，PCR/EIA 患者为 7%和 9%）无差异。PCR/EIA 患者 CDI 相关并发症的预测因素包括 IDSA 标准的基线严重疾病、基线暴发性结肠炎和体温>38.5°C。确定 PCR/EIA 患者中具有真正疾病的亚组，并因此针对这些患者进行治疗是至关重要的。
