怀疑艰难梭菌感染患者毒素EIA阳性的临床意义：系统回顾和荟萃分析。

IF 6.1 2区医学 Q1 MICROBIOLOGY

Journal of Clinical Microbiology Pub Date : 2025-01-31 Epub Date: 2024-12-12 DOI:10.1128/jcm.00977-24

Giannoula S Tansarli, Matthew E Falagas, Ferric C Fang

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引用次数: 0

摘要

艰难梭菌感染（CDI）的实验室诊断存在争议。核酸扩增试验（NAAT）和毒素酶免疫测定（EIA）是最广泛使用的，通常是联合使用。然而，对NAAT阳性和毒素免疫测定（NAAT+/EIA-）阴性的解释是不确定的。PubMed和EMBASE检索了报告NAAT+/EIA-与NAAT+/EIA+患者临床结果的研究。这项荟萃分析纳入了46项研究，包括33,959名患者。全因死亡率（RR 0.96, 95% CI 0.80-1.15）、归因死亡率（RR 0.61, 95% CI 0.20-1.91）、暴发性CDI （RR 0.83, 95% CI 0.57-1.20）、CDI的影像学证据（RR 0.87, 95% CI 0.65-1.16）、CDI总并发症（RR 0.95, 95% CI 0.59-1.53）、结肠切除术（RR 0.78, 95% CI 0.34-1.79）和ICU入院（RR 1.04, 95% CI 0.84-1.30）在NAAT+/EIA-和NAAT+/EIA+患者之间无显著差异。然而，NAAT+/EIA-患者的CDI复发率（RR 0.62, 95% CI 0.50-0.77）或严重CDI发生率（RR 0.74, 95% CI 0.63-0.88）明显低于NAAT+/EIA+患者。因CDI而接受抗生素治疗的NAAT+/EIA-患者的总患病率为73.4%（合并比例0.72,95% CI 0.52-0.88）。与NAAT+/EIA+患者相比，NAAT+/EIA-患者的复发率较低，发生严重CDI的风险较低，但与NAAT+/EIA+患者相比，发生CDI相关并发症和死亡的风险较低。毒素结果不能排除或排除CDI，决定是否治疗有症状的NAAT+/EIA-患者的CDI应基于临床表现，而不是毒素结果。艰难梭菌感染（CDI）是医疗保健相关感染的常见原因，也是抗生素相关性腹泻的主要原因。然而，主要通过核酸扩增试验（NAAT）和酶免疫测定（EIA）进行CDI的实验室诊断存在争议，特别是在NAAT检测阳性而EIA检测阴性的患者中。在本系统综述中，我们比较了NAAT+/EIA-与NAAT+/EIA+患者的临床结果，发现两组患者的死亡率和cdi相关并发症的风险相似。然而，NAAT+/EIA-患者的复发率和严重CDI的发生率明显低于NAAT+/EIA-患者，并且大多数NAAT+/EIA-患者接受了CDI治疗。毒素检测有助于预测CDI复发或严重感染的可能性，但毒素检测结果不应成为CDI治疗的决定性因素。是否治疗NAAT+/EIA-患者应根据临床评估来决定。

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Clinical significance of toxin EIA positivity in patients with suspected Clostridioides difficile infection: systematic review and meta-analysis.

The laboratory diagnosis of Clostridioides difficile infection (CDI) is controversial. Nucleic acid amplification tests (NAAT) and toxin enzyme immunoassays (EIA) are most widely used, often in combination. However, the interpretation of a positive NAAT and negative toxin immunoassay (NAAT+/EIA-) is uncertain. PubMed and EMBASE were searched for studies reporting clinical outcomes in NAAT+/EIA- versus NAAT+/EIA+ patients. Forty-six studies comprising 33,959 patients were included in this meta-analysis. All-cause mortality (RR 0.96, 95% CI 0.80-1.15), attributable mortality (RR 0.61, 95% CI 0.20-1.91), fulminant CDI (RR 0.83, 95% CI 0.57-1.20), radiographic evidence of CDI (RR 0.87, 95% CI 0.65-1.16), total CDI complications (RR 0.95, 95% CI 0.59-1.53), colectomies (RR 0.78, 95% CI 0.34-1.79), and ICU admission (RR 1.04, 95% CI 0.84-1.30) did not significantly differ between NAAT+/EIA- and NAAT+/EIA+ patients. However, rates of recurrent (RR 0.62, 95% CI 0.50-0.77) or severe (RR 0.74, 95% CI 0.63-0.88) CDI were significantly lower in NAAT+/EIA- patients than in NAAT+/EIA+ patients. The pooled prevalence of NAAT+/EIA- patients who were treated with antibiotics for CDI was 73.4% (pooled proportion 0.72, 95% CI 0.52-0.88). NAAT+/EIA- patients have lower rates of recurrence and are at reduced risk for severe CDI compared with NAAT+/EIA+ patients but have a risk of CDI-related complications and mortality comparable to that of NAAT+/EIA+ patients. Toxin results cannot rule in or rule out CDI, and the decision whether to treat symptomatic NAAT+/EIA- patients for CDI should be based on clinical presentation and not on the toxin result.IMPORTANCEClostridioides difficile infection (CDI) is a common cause of healthcare-associated infections and the leading cause of antibiotic-associated diarrhea. However, the laboratory diagnosis of CDI, primarily done by nucleic acid amplification test (NAAT) and enzyme immunoassay (EIA), is controversial, especially in patients who test positive by NAAT but negative by EIA. In this systematic review, we compared the clinical outcomes of NAAT+/EIA- versus NAAT+/EIA+ patients and found that the two groups have similar risk of mortality and CDI-related complications. However, NAAT+/EIA- patients had significantly lower rates of recurrence and severe CDI than NAAT+/EIA+ patients, and most NAAT+/EIA- patients received CDI therapy. Toxin testing can help to predict the likelihood of CDI recurrence or severe infection, but the toxin result should not be a determining factor in the administration of CDI therapy. The decision on whether to treat NAAT+/EIA- patients should be based on clinical assessment.

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来源期刊

Journal of Clinical Microbiology 医学-微生物学

CiteScore

17.10

自引率

4.30%

发文量

347

审稿时长

3 months

期刊介绍： The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.