Authors
Yanan Yao, Zanzan Sun, Jianguo Zhang, Zhimin Tao
Published in
Frontiers in immunology. Volume 17. Pages 1903694. Epub Aug 07, 2026.
Abstract
Severe fever with thrombocytopenia syndrome (SFTS), caused by SFTS virus (SFTSV) infection, is an emerging tick-borne infectious disease associated with substantial case fatality and poses a considerable public health burden. Interleukin-10 (IL-10), an important anti-inflammatory and immunoregulatory cytokine, may reflect the magnitude of immune dysregulation in SFTS. This systematic review and meta-analysis primarily aimed to evaluate the association between serum IL-10 levels and mortality in patients with SFTSV infection. As a secondary exploratory objective, we assessed the threshold-based prognostic accuracy of IL-10 for fatal outcomes when sufficient data were available.
PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and CQVIP were searched from database inception to October 11, 2025. Prospective and retrospective cohort studies, and case-control studies reporting serum IL-10 levels in survivors and non-survivors with laboratory-confirmed SFTSV infection were eligible. Two reviewers independently screened studies, extracted data, and assessed methodological quality using the Newcastle-Ottawa Scale (NOS) and risk of bias using the Quality In Prognosis Studies (QUIPS) tool for studies on prognostic factors and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool for studies contributing threshold-based prognostic accuracy data. Standardized mean differences (SMDs) with 95% confidence intervals (CIs) were pooled using a prespecified random-effects model. Sensitivity analyses, subgroup analyses, meta-regression, funnel plots, and Egger's test were used to evaluate the robustness of the findings and possible small-study effects.
Twelve studies involving 1,270 patients with SFTSV infection were included, comprising 290 non-survivors and 980 survivors. Serum IL-10 levels were significantly higher in non-survivors than in survivors (pooled SMD = 2.08, 95% CI: 1.40-2.76; P<0.01). Substantial heterogeneity was observed (I 2 = 94%, P<0.01), and the 95% prediction interval crossed zero. Sensitivity analyses generally preserved the direction of the association, including an analysis restricted to studies not requiring conversion from medians and quantiles; however, substantial residual heterogeneity and the limited number of directly reported datasets indicated considerable uncertainty regarding the magnitude of the pooled effect. Subgroup analyses according to study design showed a directionally consistent association, whereas exploratory meta-regression found no statistically significant relationship between study-level IL-10 concentration and effect size. Funnel-plot asymmetry and Egger's regression test indicated possible small-study effects; however, the extreme between-study heterogeneity limited the ability to distinguish selective publication from methodological or clinical variability. Threshold-based prognostic-accuracy analyses suggested potential discriminatory value for mortality prediction, but they were based on only three studies using post hoc, non-validated cut-off values and therefore remained exploratory. The certainty of evidence for the association between IL-10 levels and mortality was rated as very low because of residual confounding, inconsistency, indirectness, and possible small-study effects.
Elevated serum IL-10 levels were associated with mortality in SFTS; however, the certainty of evidence was very low. IL-10 should therefore be considered a candidate prognostic biomarker requiring further prospective validation rather than a clinically established stand-alone prognostic tool.
https://www.crd.york.ac.uk/prospero/, identifier CRD420251149587.
PMID:
42630216
Bibliographic data and abstract were imported from PubMed on 22 Aug 2026.
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