Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH.
Multicenter Validation of Association Between Decline in MRI-PDFF and Histologic Response in NASH.
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DOI：
10.1002/hep.31121
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发表时间：
2020-10
期刊：
影响因子：
--
通讯作者：
NASH Clinical Research Network
中科院分区：
文献类型：
--
作者：
Loomba R;Neuschwander-Tetri BA;Sanyal A;Chalasani N;Diehl AM;Terrault N;Kowdley K;Dasarathy S;Kleiner D;Behling C;Lavine J;Van Natta M;Middleton M;Tonascia J;Sirlin C;NASH Clinical Research Network
一项单中心研究的新数据表明，通过磁共振成像 - 质子密度脂肪分数（MRI - PDFF）评估，肝脏脂肪含量从基线相对降低30%可能与非酒精性脂肪性肝炎（NASH）的组织学改善相关。比较活性药物与安慰剂在通过MRI - PDFF评估的肝脏脂肪减少量与NASH组织学反应之间关联的多中心数据有限。
在FLINT试验中，检验奥贝胆酸与安慰剂治疗患者中MRI - PDFF相对降低30%与组织学反应之间的关联。
这是对FLINT试验的二次分析，包括78名患者，在治疗前后进行了MRI - PDFF测量以及配对的肝脏组织学评估。组织学反应定义为非酒精性脂肪性肝病活动评分改善2分且纤维化无恶化。
每日口服一次25mg奥贝胆酸在改善MRI - PDFF方面优于安慰剂，绝对差值为 - 3.4%（95%置信区间， - 6.5至 - 0.2%，p值 = 0.04），相对差值为 - 17%（95%置信区间， - 34至0%，p值 = 0.05）。对于组织学反应，MRI - PDFF相对下降的最佳截断点为30%（使用约登指数）。MRI - PDFF较基线下降<30%的患者与MRI - PDFF较基线下降≥30%（MRI - PDFF应答者）的患者的组织学反应率分别为19%和50%。与MRI - PDFF无应答者相比，MRI - PDFF应答者在组织学反应方面具有统计学和临床上显著更高的优势比4.86（95%置信区间，1.4 - 12.8，p值<0.009），包括脂肪变性和气球样变均有显著改善。
奥贝胆酸在减少肝脏脂肪方面优于安慰剂。这项多中心试验提供了关于MRI - PDFF相对于基线下降30%与NASH组织学反应之间关联的新数据。
Emerging data from a single center study suggests that a 30% relative reduction in liver fat content as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline may be associated with histologic improvement in nonalcoholic steatohepatitis (NASH). There are limited multicenter data comparing an active drug versus placebo on the association between the quantity of liver fat reduction assessed by MRI-PDFF and histologic response in NASH. To examine the association between 30% relative reduction in MRI-PDFF and histologic response in obeticholic acid versus placebo-treated patients in the FLINT trial. This is a secondary analysis of the FLINT trial including 78 patients with MRI-PDFF measured before and after treatment along with paired liver histology assessment. Histologic response was defined as a two-point improvement in NAFLD Activity Score without worsening of fibrosis. Obeticholic acid at 25 mg orally once daily was better than placebo in improving MRI-PDFF by an absolute difference of −3.4% (95% CI, −6.5 to −0.2%, p-value=0.04), and relative difference of −17% (95% CI, −34 to 0%, p-value=0.05). The optimal cut-point for relative decline in MRI-PDFF for histologic response was 30%. (using Youden’s index). The rate of histologic response in those who achieved < 30% decline in MRI-PDFF versus those who achieved a ≥ 30% decline in MRI-PDFF (MRI-PDFF responders) relative to baseline was 19% versus 50%, respectively. Compared to MRI-PDFF non-responders, MRI-PDFF responders demonstrated both a statistically and clinically significant higher odds 4.86 (95% CI, 1.4–12.8, p-value <0.009) of histologic response including significant improvements in both steatosis and ballooning. Obeticholic acid was better than placebo in reducing liver fat. This multicenter trial provides novel data regarding the association between 30% decline in MRI-PDFF relative to baseline and histologic response in NASH.
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DOI：
10.1002/hep.29639
发表时间：
2018-04
期刊：
Hepatology (Baltimore, Md.)
影响因子：
--
作者：
Caussy C;Alquiraish MH;Nguyen P;Hernandez C;Cepin S;Fortney LE;Ajmera V;Bettencourt R;Collier S;Hooker J;Sy E;Rizo E;Richards L;Sirlin CB;Loomba R
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期刊：
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发表时间：
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影响因子：
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发表时间：
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期刊：
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影响因子：
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