Benefits of prolonged-release pirfenidone plus standard of care treatment in patients with advanced liver fibrosis: PROMETEO study.
Benefits of prolonged-release pirfenidone plus standard of care treatment in patients with advanced liver fibrosis: PROMETEO study.
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长时间释放的吡非酮的好处以及晚期肝纤维化患者的护理治疗：Prometeo研究。
DOI：
10.1007/s12072-020-10069-3
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发表时间：
2020-09
影响因子：
6.6
通讯作者：
Muñoz-Espinosa LE
中科院分区：
文献类型：
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作者：
Poo JL;Torre A;Aguilar-Ramírez JR;Cruz M;Mejía-Cuán L;Cerda E;Velázquez A;Patiño A;Ramírez-Castillo C;Cisneros L;Bosques-Padilla F;Hernández L;Gasca F;Flores-Murrieta F;Treviño S;Tapia G;Armendariz-Borunda J;Muñoz-Espinosa LE
吡非尼酮（PFD）是一种口服抗纤维化药物，已获得 EMA 和 FDA 批准用于治疗特发性肺纤维化。很少有研究探讨其在晚期肝纤维化（ALF）中的应用。我们评估了缓释制剂 (PR-PFD) 加上护理标准对 ALF 疾病进展的影响。对来自 12 个中心接受 PR-PFD（600 mg bid）的 281 名 ALF 患者进行了筛查； 122 人完成了 1 年的治疗。此外，74 名患者仅接受标准护理方案。平均年龄为 64±12 岁，其中 58% 为女性。 43.5% 患有脂肪肝病 (NAFLD)、22.5% 患有丙型肝炎 (VHC)、17% 患有自身免疫性肝炎 (AIH) 和 17% 患有酒精性肝病 (ALD)。基线纤维化为 F4（74%）和 F3（26%）。通过瞬时弹性成像 (Fibroscan®) 和 Fibro Test® (FT) 评估抗纤维化效果；跟踪细胞因子和 PFD 血浆水平并评估生活质量。我们发现 35% 的 PR-PFD 患者的纤维化显着减少，而非 PR-PFD 患者的纤维化程度仅为 4.1%。 Child-Pugh 评分提高了 29.7%。生化值保持稳定； ALT 或 AST 分别下降 40.6% 和 43.3%。 PFD 治疗患者的 TGFβ1 (pg/mL) 水平较低。与纤维化进展谱 (FPP) 患者相比，纤维化消退谱 (FRP) 患者的 PFD 血清浓度 (μg/mL) 较高 (8.2±±1.7) (4.7±0.3 µg/mL，p<0.01)。 12% 的人报告有短暂的烧灼感或恶心，7% 的人报告光过敏。生活质量（Euro-Qol 量表）从 62 ± 5 提高到 84 ± 3 (p < 0.001)，从 32 ± 3 提高到 42 ± 2 (p < 0.008)（FACIT 量表）。 PR-PFD 对 ALF 有效且安全，并且具有良好的抗纤维化作用。临床试验编号：NCT04099407。
Pirfenidone (PFD), an oral antifibrotic drug, has been authorized by the EMA and FDA for treatment of idiopathic pulmonary fibrosis. Few studies have addressed its use in advanced liver fibrosis (ALF). We evaluated a prolonged-release formulation (PR-PFD) plus standard of care on disease progression in ALF. 281 ALF patients from 12 centers receiving PR-PFD (600 mg bid) were screened; 122 completed 1 year of treatment. Additionally, 74 patients received only standard of care regimen. Average age was 64 ± 12 years, 58% female. 43.5% had fatty liver disease (NAFLD), 22.5% viral hepatitis C (VHC), 17% autoimmune hepatitis (AIH), and 17% alcoholic liver disease (ALD). Baseline fibrosis was F4 in 74% and F3 in 26%. Antifibrotic effects were assessed by transient elastography (Fibroscan®) and Fibro Test® (FT); Cytokines and PFD plasma levels were tracked and quality of life evaluated. We found a significant reduction in fibrosis in 35% of PR-PFD patients and only in 4.1% in non PR-PFD patients. Child–Pugh score improved in 29.7%. Biochemical values remained stable; 40.6% and 43.3% decreased ALT or AST, respectively. TGFβ1 (pg/mL) levels were lower in PFD-treated patients. PFD serum concentration (µg/mL) was higher (8.2 ± 1.7) in fibrosis regression profile (FRP) patients compared to fibrosis progression profile (FPP) patients (4.7 ± 0.3 µg/mL, p < 0.01). 12% reported transient burning or nausea and 7% photosensitivity. Quality of life (Euro-Qol scale) improved from 62 ± 5 to 84 ± 3 (p < 0.001) and from 32 ± 3 to 42 ± 2 (p < 0.008) (FACIT scale). PR-PFD is efficacious and safe in ALF and associated with promising antifibrotic effects. Clinical trial number: NCT04099407.
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影响因子：
3.6
作者：
Lopez-de la Mora DA;Sanchez-Roque C;Montoya-Buelna M;Sanchez-Enriquez S;Lucano-Landeros S;Macias-Barragan J;Armendariz-Borunda J
通讯作者：
Armendariz-Borunda J
影响因子：
25.7
作者：
Poynard, Thierry;Vergniol, Julien;de Ledinghen, Victor
通讯作者：
de Ledinghen, Victor
影响因子：
5.5
作者：
Li C;Li R;Zhang W
通讯作者：
Zhang W
影响因子：
13.5
作者：
Mauro, Ezequiel;Crespo, Gonzalo;Navasa, Miquel
通讯作者：
Navasa, Miquel
DOI：
10.1186/1755-1536-3-16
发表时间：
2010-09-01
期刊：
Fibrogenesis & tissue repair
影响因子：
--
作者：
Macías-Barragán J;Sandoval-Rodríguez A;Navarro-Partida J;Armendáriz-Borunda J
通讯作者：
Armendáriz-Borunda J