Ferreira Germano, Stuurman Anke L, Horsmans Yves, Cattaert Tom, Verstraeten Thomas, Feng Yang, Rosillon Dominique, Guignard Adrienne
P95, Pharmacovigilance and Epidemiology, Leuven.
Cliniques Universitaires Saint-Luc, UC Louvain, Bruxelles.
Eur J Gastroenterol Hepatol. 2020 Jan;32(1):101-109. doi: 10.1097/MEG.0000000000001537.
Assess the risk of progression to cirrhosis and hepatocellular carcinoma (HCC) due to hepatitis B virus (HBV)-infection in patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (T2DM).
Retrospective cohort study in the UK Clinical Practice Research Datalink with three cohorts: subjects with T2DM and HBV infection (T2DM+HBV cohort; N = 297), with T2DM without HBV-infection (T2DM cohort; N = 261 865), and with HBV-infection without T2DM (HBV cohort; N = 3630). Primary analyses were performed on the three cohorts and secondary analyses on subcohorts including patients with NAFLD diagnosis code (N = 6599). Case/outcome definitions were formulated with International Classification of Diseases/Read codes/laboratory results and classified using validated algorithms. Adjusted incidence rate ratios (IRR) were estimated with a Poisson regression model.
When comparing the T2DM+HBV and T2DM cohorts, adjusted IRRs were 14.06 (95% confidence interval: 4.47-44.19) for cirrhosis and 2.83 (1.06-7.55) for HCC. When comparing the T2DM+HBV and HBV cohorts, adjusted IRRs were 0.68 (0.21-2.27) for cirrhosis and 1.39 (0.46-4.20) for HCC. No cirrhosis cases were identified in T2DM+NAFLD+HBV patients; IRs were 16.92/10 000 person-years (12.97-21.69) and 85.24/10 000 person-years (10.32-307.91) in the T2DM+NAFLD and NAFLD+HBV cohorts.
HBV-infection increased significantly the risk for cirrhosis among T2DM patients, however, not beyond the expected incremental risk among infected non-T2DM subjects. Our approach to evaluate the role of T2DM/NAFLD and HBV-infection in liver disease progression could be applied to other settings with higher HBV prevalence.
评估非酒精性脂肪性肝病(NAFLD)和2型糖尿病(T2DM)患者因感染乙型肝炎病毒(HBV)进展为肝硬化和肝细胞癌(HCC)的风险。
在英国临床实践研究数据链中进行回顾性队列研究,分为三个队列:T2DM合并HBV感染的受试者(T2DM+HBV队列;N = 297)、患有T2DM但未感染HBV的受试者(T2DM队列;N = 261865)以及感染HBV但未患T2DM的受试者(HBV队列;N = 3630)。对这三个队列进行了初步分析,并对包括有NAFLD诊断代码的患者(N = 6599)的亚队列进行了二次分析。病例/结局定义根据国际疾病分类/读取代码/实验室结果制定,并使用经过验证的算法进行分类。采用泊松回归模型估计调整后的发病率比(IRR)。
比较T2DM+HBV队列和T2DM队列时,肝硬化的调整后IRR为14.06(95%置信区间:4.47 - 44.19),HCC的调整后IRR为2.83(1.06 - 7.55)。比较T2DM+HBV队列和HBV队列时,肝硬化的调整后IRR为0.68(0.21 - 2.27),HCC的调整后IRR为1.39(0.46 - 4.20)。在T2DM+NAFLD+HBV患者中未发现肝硬化病例;T2DM+NAFLD队列和NAFLD+HBV队列的发病率分别为16.92/10000人年(12.97 - 21.69)和85.24/10000人年(10.32 - 307.91)。
HBV感染显著增加了T2DM患者发生肝硬化的风险,但不超过感染HBV的非T2DM受试者预期的额外风险。我们评估T2DM/NAFLD和HBV感染在肝病进展中作用的方法可应用于HBV患病率较高的其他情况。