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一种使用一目了然的一线检测方法对晚期肝纤维化和肝硬化进行非侵入性诊断的逐步算法。

A stepwise algorithm using an at-a-glance first-line test for the non-invasive diagnosis of advanced liver fibrosis and cirrhosis.

机构信息

Hepatology Department, University Hospital, Angers, France; HIFIH Laboratory, UPRES 3859, SFR 4208, Bretagne Loire University, Angers, France.

Hepatology Unit, Haut-Lévêque Hospital, Bordeaux University Hospital, Pessac, France; INSERM U1053, Bordeaux University, Bordeaux, France.

出版信息

J Hepatol. 2017 Jun;66(6):1158-1165. doi: 10.1016/j.jhep.2017.01.003. Epub 2017 Jan 12.

DOI:10.1016/j.jhep.2017.01.003
PMID:28088581
Abstract

BACKGROUND & AIMS: Chronic liver diseases (CLD) are common, and are therefore mainly managed by non-hepatologists. These physicians lack access to the best non-invasive tests of liver fibrosis, and consequently cannot accurately determine the disease severity. Referral to a hepatologist is then needed. We aimed to implement an algorithm, comprising a new first-line test usable by all physicians, for the detection of advanced liver fibrosis in all CLD patients.

METHODS

Diagnostic study: 3754 CLD patients with liver biopsy were 2:1 randomized into derivation and validation sets. Prognostic study: longitudinal follow-up of 1275 CLD patients with baseline fibrosis tests.

RESULTS

Diagnostic study: the easy liver fibrosis test (eLIFT), an "at-a-glance" sum of points attributed to age, gender, gamma-glutamyl transferase, aspartate aminotransferase (AST), platelets and prothrombin time, was developed for the diagnosis of advanced fibrosis. In the validation set, eLIFT and fibrosis-4 (FIB4) had the same sensitivity (78.0% vs. 76.6%, p=0.470) but eLIFT gave fewer false positive results, especially in patients ≥60years old (53.8% vs. 82.0%, p<0.001), and was thus more suitable as screening test. FibroMeter with vibration controlled transient elastography (VCTE) was the most accurate among the eight fibrosis tests evaluated. The sensitivity of the eLIFT-FM algorithm (first-line eLIFT, second-line FibroMeter) was 76.1% for advanced fibrosis and 92.1% for cirrhosis. Prognostic study: patients diagnosed as having "no/mild fibrosis" by the algorithm had excellent liver-related prognosis with thus no need for referral to a hepatologist.

CONCLUSION

The eLIFT-FM algorithm extends the detection of advanced liver fibrosis to all CLD patients and reduces unnecessary referrals of patients without significant CLD to hepatologists.

LAY SUMMARY

Blood fibrosis tests and transient elastography accurately diagnose advanced liver fibrosis in the large population of patients having chronic liver disease, but these non-invasive tests are only currently available in specialized centers. We have developed an algorithm including the easy liver fibrosis test (eLIFT), a new simple and widely available blood test. It is used as a first-line procedure that selects at-risk patients who need further evaluation with the FibroMeter, an accurate fibrosis test combining blood markers and transient elastography result. This new algorithm, called the eLIFT-FM, accurately identifies the patients with advanced chronic liver disease who need referral to a specialist, and those with no or mild liver lesions who can remain under the care of their usual physician.

CLINICAL TRIAL REGISTRATION

No registration (analysis of pooled data from previously published diagnostic studies).

摘要

背景与目的

慢性肝病(CLD)较为常见,主要由非肝病专家管理。这些医生无法获得最佳的非侵入性肝纤维化检测,因此无法准确确定疾病的严重程度。然后需要转介给肝病专家。我们旨在实施一种算法,该算法包括一种新的一线测试,所有医生均可使用,用于检测所有 CLD 患者的晚期肝纤维化。

方法

诊断研究:3754 例接受肝活检的 CLD 患者按 2:1 随机分为推导组和验证组。预后研究:对 1275 例基线纤维化检测的 CLD 患者进行纵向随访。

结果

诊断研究:简单肝纤维化检测(eLIFT)是一种“一目了然”的积分,由年龄、性别、γ-谷氨酰转移酶、天门冬氨酸氨基转移酶(AST)、血小板和凝血酶原时间相加而成,用于诊断晚期纤维化。在验证组中,eLIFT 和纤维化 4 指数(FIB4)的敏感性相同(78.0% vs. 76.6%,p=0.470),但 eLIFT 假阳性结果较少,尤其是在年龄≥60 岁的患者中(53.8% vs. 82.0%,p<0.001),因此更适合作为筛查试验。FibroMeter 联合振动控制瞬时弹性成像(VCTE)是评估的 8 种纤维化检测中最准确的。eLIFT-FM 算法(一线 eLIFT,二线 FibroMeter)检测晚期纤维化的敏感性为 76.1%,肝硬化的敏感性为 92.1%。预后研究:通过算法诊断为“无/轻度纤维化”的患者具有极好的肝脏相关预后,因此无需转介给肝病专家。

结论

eLIFT-FM 算法将晚期肝纤维化的检测扩展到所有 CLD 患者,并减少了对无明显 CLD 的患者向肝病专家的不必要转诊。

摘要

血液纤维化检测和瞬时弹性成像可以准确诊断出患有慢性肝病的大量患者的晚期肝纤维化,但这些非侵入性检测目前仅在专门中心提供。我们开发了一种算法,其中包括简单肝纤维化检测(eLIFT),这是一种新的简单且广泛可用的血液检测。它作为一线程序使用,可选择需要进一步使用 FibroMeter 评估的高危患者,FibroMeter 是一种结合血液标志物和瞬时弹性成像结果的准确纤维化检测。这种新的算法称为 eLIFT-FM,可准确识别需要转介给专家的晚期慢性肝病患者,以及无或轻度肝损伤的患者,他们可以继续由其常规医生进行治疗。

临床试验注册

无注册(对先前发表的诊断研究的汇总数据进行分析)。

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