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一组血清生物标志物(胃功能检测组合®)用于萎缩性胃炎的无创诊断。系统评价与荟萃分析。

A Panel of Serum Biomarkers (GastroPanel®) in Non-invasive Diagnosis of Atrophic Gastritis. Systematic Review and Meta-analysis.

作者信息

Syrjänen Kari

机构信息

Department of Clinical Research, Biohit Oyj, Helsinki, Finland

Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, SP, Brazil.

出版信息

Anticancer Res. 2016 Oct;36(10):5133-5144. doi: 10.21873/anticanres.11083.

Abstract

BACKGROUND/AIM: To meet the increasing demand of non-invasive tests for screening of gastric cancer (GC) risk, biomarker panel (GastroPanel®) (GP) was designed by Biohit Oyj as the first serological test for stomach health. The aim of the present study was to perform a systematic review and meta-analysis of all studies on GP in diagnosis of atrophic gastritis (AG).

MATERIALS AND METHODS

Studies were eligible, if i) GP was used to diagnose biopsy-confirmed AG of the corpus (AGC) and/or antrum (AGA) and ii) exact numbers were available to enable calculating sensitivity (SE) and specificity (SP). Comprehensive Meta-Analysis software was used with maximum likelihood meta-regression (R analog). Effect size estimates (SE; SP, 95% confidence interval (CI)) were tested for homogeneity with Cochran's Q and I statistics. Potential publication bias was estimated by funnel plot statistics.

RESULTS

Altogether, 27 studies were eligible comprising of 8,654 patients from different geographic regions. Significant heterogeneity between studies reporting AGC (n=27) or AGA (n=13) warranted random effects (RE) model for summary statistics. GP performs better in diagnosing AGC than AGA with 70.2% vs. 51.6% pooled SE and 93.9% vs. 84.1% pooled SP, respectively. Limited number of studies erodes the Q test's power to detect true heterogeneity in meta-analysis stratified by geographic study origin. Few hypothetical missing studies had only marginal effect on pooled estimates of SE and SP.

CONCLUSION

This first meta-analysis of GP literature corroborates the statement of international experts, advocating GP in diagnosis and screening of AG. Due to its high specificity for both AGA and AGC, GastroPanel® is truly a test for stomach health.

摘要

背景/目的:为满足对胃癌(GC)风险进行无创检测筛查的需求不断增加,Biohit Oyj公司设计了生物标志物组合(GastroPanel®)(GP)作为首个用于胃部健康的血清学检测。本研究的目的是对所有关于GP诊断萎缩性胃炎(AG)的研究进行系统评价和荟萃分析。

材料与方法

符合条件的研究需满足:i)GP用于诊断经活检证实的胃体萎缩性胃炎(AGC)和/或胃窦萎缩性胃炎(AGA);ii)有确切数字以计算敏感性(SE)和特异性(SP)。使用综合荟萃分析软件及最大似然荟萃回归(R模拟)。效应量估计值(SE;SP,95%置信区间(CI))用Cochran's Q和I统计量检验同质性。通过漏斗图统计估计潜在的发表偏倚。

结果

总共27项研究符合条件,涉及来自不同地理区域的8654名患者。报告AGC(n = 27)或AGA(n = 13)的研究之间存在显著异质性,因此汇总统计采用随机效应(RE)模型。GP诊断AGC的表现优于AGA,汇总SE分别为70.2%和51.6%,汇总SP分别为93.9%和84.1%。研究数量有限削弱了Q检验在按地理研究来源分层的荟萃分析中检测真正异质性的能力。少数假设的缺失研究对SE和SP的汇总估计仅有微小影响。

结论

对GP文献的首次荟萃分析证实了国际专家的观点,支持将GP用于AG的诊断和筛查。由于其对AGA和AGC均具有高特异性,GastroPanel®确实是一种胃部健康检测方法。

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