Nuffield Department of Primary Care Health SciencesUniversity of OxfordOxfordUK.
National Institute for Health Research (NIHR) Oxford Biomedical Research CentreOxford University Hospitals NHS Foundation TrustOxfordUK.
Hepatol Commun. 2022 Oct;6(10):2623-2633. doi: 10.1002/hep4.2044. Epub 2022 Jul 28.
Nonalcoholic steatohepatitis (NASH) is a prevalent chronic disease that is associated with a spectrum of liver fibrosis and can lead to cirrhosis. Patients with NASH report lower health-related quality of life (HRQoL) than the general population. It remains uncertain how changes in histologic severity are associated with changes in HRQoL. This is a secondary analysis of the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment (FLINT) and Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis (PIVENS) randomized controlled trials in patients with biopsy-proven NASH. HRQoL was assessed using short form-36 at baseline and at follow-up biopsy (at 72 and 96 weeks, respectively). Adjusted linear regression models were used to examine the association between changes in liver fibrosis (primary analysis), nonalcoholic fatty liver disease (NAFLD) activity score (secondary analysis), and changes in HRQoL scores. Compared with stable fibrosis, improvement of fibrosis by at least one stage was significantly associated with improvements only in the physical function component by 1.8 points (95% confidence interval, 0.1, 3.5). Worsening of fibrosis by at least one stage was not associated with statistically significant changes in any HRQoL domain compared with stable fibrosis. Associations between HRQoL and NAFLD disease activity score in the secondary analysis were of similar magnitude. Weight loss was associated with small improvements in physical function, general health, and energy levels. Conclusion: Improvements in fibrosis stage were associated with improvements in the physical component of HRQoL, but the clinical impact was modest. As improving fibrosis may not meaningfully improve well-being, treatment for NASH will be cost effective only if it prevents long-term hepatic and cardiovascular disease.
非酒精性脂肪性肝炎（NASH）是一种常见的慢性疾病，与一系列肝纤维化有关，并可导致肝硬化。NASH 患者的健康相关生活质量（HRQoL）报告低于一般人群。目前尚不清楚组织学严重程度的变化如何与 HRQoL 的变化相关。这是 Farnesoid X 受体配体奥贝胆酸治疗 NASH（FLINT）和吡格列酮、维生素 E 或安慰剂治疗非酒精性脂肪性肝炎（PIVENS）随机对照试验的二次分析，这些试验纳入了经活检证实的 NASH 患者。HRQoL 在基线和随访活检时（分别为 72 周和 96 周）使用简短形式 36 进行评估。调整后的线性回归模型用于检查肝纤维化变化（主要分析）、非酒精性脂肪性肝病（NAFLD）活动评分（次要分析）与 HRQoL 评分变化之间的关联。与稳定纤维化相比，纤维化至少改善一个阶段与仅在生理功能方面提高 1.8 分（95%置信区间，0.1，3.5）显著相关。与稳定纤维化相比，纤维化至少恶化一个阶段与任何 HRQoL 领域的统计学显著变化均无关。次要分析中 HRQoL 与 NAFLD 疾病活动评分之间的关联具有相似的幅度。体重减轻与生理功能、总体健康和精力水平的微小改善有关。结论：纤维化阶段的改善与 HRQoL 的生理成分的改善相关，但临床影响是适度的。由于改善纤维化可能不会显著改善幸福感，因此只有当 NASH 的治疗能预防长期的肝脏和心血管疾病时，它才具有成本效益。
