Public Health Sciences and Medical Statistics (MP805) South Academic Block Southampton General Hospital, Southampton SO53 1ER, UK.
Gut. 2010 Sep;59(9):1245-51. doi: 10.1136/gut.2009.203166. Epub 2010 Jul 30.
Clinicians use fibrosis in a liver biopsy to predict clinical outcomes of chronic liver disease. The performance of non-invasive tests has been evaluated against histological assessment of fibrosis but use of clinical outcomes as the reference standard would be ideal. The enhanced liver fibrosis (ELF) test was derived and validated in a large cohort of patients and shown to have high diagnostic accuracy (area under the curve (AUC)=0.80 95% CI 0.76 to 0.85) in identification of significant fibrosis on biopsy.
To evaluate ELF performance in predicting clinical outcomes by following up the original ELF cohort.
Patients recruited to the ELF study at seven English centres were followed up for liver morbidity and mortality by examination of clinical data. Defaulting/discharged patients were followed up by family practitioner questionnaires. Primary outcome measure was liver-related morbidity/liver-related death.
457 patients were followed up (median 7 years), with ascertainment of clinical status in 92%. There were 61 liver-related outcomes (39 deaths). Survival analysis showed that the ELF score predicts liver outcomes, with people having the highest ELF scores being significantly more likely to have clinical outcomes than those in lower-score groups. A Cox proportional hazards model showed fully adjusted HRs of 75 (ELF score 12.52-16.67), 20 (10.426-12.51) and 5 (8.34-10.425) compared with patients with ELF <8.34. A unit change in ELF is associated with a doubling of risk of liver-related outcome.
An ELF test can predict clinical outcomes in patients with chronic liver disease and may be a useful prognostic tool in clinical practice.
临床医生通过肝活检中的纤维化来预测慢性肝病的临床结局。已经评估了非侵入性检测的性能与纤维化的组织学评估相对比，但使用临床结局作为参考标准将是理想的。增强型肝纤维化（ELF）检测是在大量患者队列中得出并验证的，在识别活检中的显著纤维化方面具有很高的诊断准确性（曲线下面积（AUC）=0.80，95%CI 0.76-0.85）。
通过随访原始 ELF 队列，评估 ELF 在预测临床结局方面的性能。
在七个英国中心招募了参加 ELF 研究的患者，通过检查临床数据对肝脏发病率和死亡率进行随访。通过家庭医生问卷对失访/出院患者进行随访。主要观察指标是与肝脏相关的发病率/与肝脏相关的死亡。
457 例患者（中位随访 7 年），92%的患者确定了临床状态。有 61 例与肝脏相关的结局（39 例死亡）。生存分析表明，ELF 评分可预测肝脏结局，ELF 评分最高的人群发生临床结局的可能性明显高于评分较低的人群。Cox 比例风险模型显示，调整后的 HR 分别为 75（ELF 评分 12.52-16.67）、20（10.426-12.51）和 5（8.34-10.425），与 ELF<8.34 的患者相比。ELF 变化一个单位与肝脏相关结局的风险增加一倍相关。
ELF 检测可预测慢性肝病患者的临床结局，可能是临床实践中的一种有用的预后工具。
