在有糖尿病和无糖尿病的患者中，经肝活检证实的非酒精性脂肪性肝病的纤维化进展率：一项多中心研究。
Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes: A Multicenter Study.
机构信息
Nonalcoholic Fatty Liver Disease Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, California; Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Gastroenterology and Hepatology, Department of Medicine, National University Health System, Singapore.
Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.
出版信息
Gastroenterology. 2023 Aug;165(2):463-472.e5. doi: 10.1053/j.gastro.2023.04.025. Epub 2023 Apr 29.
BACKGROUND & AIMS: There are limited data regarding fibrosis progression in biopsy-proven nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes mellitus (T2DM) compared with people without T2DM. We assessed the time to fibrosis progression in people with T2DM compared with people without T2DM in a large, multicenter, study of people with NAFLD who had paired liver biopsies.
METHODS
This study included 447 adult participants (64% were female) with NAFLD who had paired liver biopsies more than 1 year apart. Liver histology was systematically assessed by a central pathology committee blinded to clinical data. The primary outcome was the cumulative incidence of a ≥1-stage increase in fibrosis in participants with T2DM compared with participants without T2DM.
RESULTS
The mean (SD) age and body mass index (calculated as weight in kilograms divided by the square of the height in meters) were 50.9 (11.5) years and 34.7 (6.3), respectively. The median time between biopsies was 3.3 years (interquartile range, 1.8-6.1 years). Participants with T2DM had a significantly higher cumulative incidence of fibrosis progression at 4 years (24% vs 20%), 8 years (60% vs 50%), and 12 years (93% vs 76%) (P = .005). Using a multivariable Cox proportional hazards model adjusted for multiple confounders, T2DM remained an independent predictor of fibrosis progression (adjusted hazard ratio, 1.69; 95% CI, 1.17-2.43; P = .005). The cumulative incidence of fibrosis regression by ≥1 stage was similar in participants with T2DM compared with participants without T2DM (P = .24).
CONCLUSIONS
In this large, multicenter cohort study of well-characterized participants with NAFLD and paired liver biopsies, we found that fibrosis progressed faster in participants with T2DM compared with participants without T2DM. These data have important implications for clinical practice and trial design.
背景与目的
与非酒精性脂肪性肝病（NAFLD）患者相比，伴有 2 型糖尿病（T2DM）的 NAFLD 患者的肝纤维化进展数据有限。我们评估了在一项大型、多中心、伴有 NAFLD 且行肝活检的患者中，T2DM 患者与非 T2DM 患者的纤维化进展时间。
方法
这项研究纳入了 447 名成年 NAFLD 患者（64%为女性），他们的肝活检结果相隔 1 年以上。肝脏组织学由一个中心病理学委员会进行评估，该委员会对临床数据进行盲法评估。主要结局是 T2DM 患者与非 T2DM 患者相比，纤维化程度增加≥1 期的累积发生率。
结果
参与者的平均（SD）年龄和体重指数（计算为体重除以身高的平方）分别为 50.9（11.5）岁和 34.7（6.3）。两次活检之间的中位数时间为 3.3 年（四分位距，1.8-6.1 年）。T2DM 患者在 4 年（24%比 20%）、8 年（60%比 50%）和 12 年（93%比 76%）时纤维化进展的累积发生率显著更高（P=.005）。使用调整了多种混杂因素的多变量 Cox 比例风险模型，T2DM 仍然是纤维化进展的独立预测因素（调整后的危险比，1.69；95%CI，1.17-2.43；P=.005）。T2DM 患者与非 T2DM 患者相比，纤维化程度至少下降 1 期的累积发生率相似（P=.24）。
结论
在这项大型、多中心、有特征性 NAFLD 患者和配对肝活检的队列研究中，我们发现 T2DM 患者的纤维化进展速度快于非 T2DM 患者。这些数据对临床实践和试验设计具有重要意义。
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