AbstractPeople with type 2 diabetes mellitus (T2DM) show a high prevalence of steatotic liver disease (SLD), and especially metabolic dysfunction-associated steatotic liver disease (MASLD), with liver fibrosis. Their health-related quality of life (HRQL) is affected by multiple in part overlapping factors and aggravated by metabolic and liver-related comorbidities, including liver fibrosis stage.

摘要2型糖尿病（T2DM）患者脂肪变性肝病（SLD）的患病率很高，尤其是代谢功能障碍相关的脂肪变性肝病（MASLD），并伴有肝纤维化。他们的健康相关生活质量（HRQL）受到多种部分重叠因素的影响，并因代谢和肝脏相关合并症（包括肝纤维化阶段）而加剧。

The aim of this study was to investigate the effect size of advanced fibrosis (AF) on the HRQL in people with T2DM. A total of 149 individuals with T2DM treated at a primary care provider within the German disease management program (DMP) were included in the final analysis. Vibration-controlled transient elastography (VCTE) was used to non-invasively detect steatosis and AF.

本研究的目的是调查晚期纤维化（AF）对T2DM患者HRQL的影响大小。最终分析包括在德国疾病管理计划（DMP）的初级保健提供者接受治疗的149名T2DM患者。振动控制瞬态弹性成像（VCTE）用于无创检测脂肪变性和房颤。

The EQ-5D-3L questionnaire was used to assess the HRQL. Uni- and multivariable linear regression models were used to identify independent predictors of impaired HRQL. The majority was male (63.1%), and the median age was 67 years (IQR 59; 71). In the entire cohort, the prevalence of MASLD and AF was 70.7% and 19.5%, respectively.

EQ-5D-3L问卷用于评估HRQL。使用单变量和多变量线性回归模型来识别HRQL受损的独立预测因子。大多数是男性（63.1%），中位年龄为67岁（IQR 59；71）。在整个队列中，MASLD和AF的患病率分别为70.7%和19.5%。

People with T2DM and AF had an overall lower HRQL in comparison to those without AF (p < 0.001). Obesity (β: − 0.247; 95% CI − 0.419, − 0.077) and AF (β: − 0.222; 95% CI − 0.383, − 0.051) remained independent predictors of a poor HRQL. In turn, T2DM-related comorbidities were not predictive of an impaired HRQL.

与无房颤患者相比，T2DM和房颤患者的HRQL总体较低（p<0.001）。肥胖（β：0.247；95%可信区间0.419，0.077）和房颤（β：0.222；95%可信区间0.383，0.051）仍然是HRQL差的独立预测因子。反过来，与T2DM相关的合并症不能预测HRQL受损。

Obesity and AF negatively affect the HRQL in patients with SLD and T2DM in primary care. Awareness of liver health and specific interventions may improve patient-reported and liver-related outcomes in people with T2DM..

。对肝脏健康和特定干预措施的认识可能会改善T2DM患者的患者报告和肝脏相关结局。。

IntroductionSteatotic liver disease (SLD) and especially metabolic dysfunction-associated steatotic liver disease (MASLD) has become the most common chronic liver disease with an estimated global prevalence of 30%1. Major risk factors for developing MASLD are type 2 diabetes mellitus (T2DM) and obesity, with a markedly elevated prevalence of MASLD if these conditions are present2,3,4.

引言脂肪变性肝病（SLD），特别是代谢功能障碍相关的脂肪变性肝病（MASLD）已成为最常见的慢性肝病，估计全球患病率为30%1。发生MASLD的主要危险因素是2型糖尿病（T2DM）和肥胖，如果存在这些情况，MASLD的患病率显着升高2,3,4。

Along the disease course, MASLD can progress to metabolic dysfunction-associated steatohepatitis (MASH), with increasing scarring of liver tissue resulting in liver fibrosis5. Progression of liver fibrosis can lead to advanced fibrosis (AF; F3) and even liver cirrhosis (F4), with increased morbidity and mortality6.

在疾病过程中，MASLD可以进展为代谢功能障碍相关的脂肪性肝炎（MASH），肝组织瘢痕形成增加导致肝纤维化5。肝纤维化的进展可导致晚期纤维化（AF；F3）甚至肝硬化（F4），发病率和死亡率增加6。

As a result of the increasing burden of chronic liver disease related to MASLD, non-invasive tests (NITs), including vibration-controlled transient elastography (VCTE, Fibroscan®), have been developed to identify patients at risk in need of more intensive care and surveillance7. However, only few data on the use of VCTE is available from primary care settings, although the majority of patients with T2DM are routinely seen by primary care providers8.An important aspect in the care of patients is the health-related quality of life (HRQL)—a term that describes the patient’s physical, mental, and social functioning, individual perception of their health status, and the overall well-being associated with the disease.

由于与MASLD相关的慢性肝病负担越来越重，已经开发了包括振动控制瞬时弹性成像（VCTE，Fibroscan®）在内的非侵入性测试（NIT），以识别需要更多重症监护和监测的风险患者7。然而，尽管大多数T2DM患者经常被初级保健提供者看到，但初级保健机构只有很少的关于VCTE使用的数据8。患者护理的一个重要方面是与健康相关的生活质量（HRQL）-一个描述患者身体，心理和社会功能，个人对健康状况的感知以及与疾病相关的整体幸福感的术语。

Several questionnaires have been developed for the assessment of the HRQL. A generic questionnaire is the EQ-5D-3L that can assess the current health state, and provide an estimate of the overall HRQL9. The EQ-5D-3L consists of five dimensions that capture various aspects of someone’s health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).

已经开发了几个问卷来评估HRQL。通用问卷是EQ-5D-3L，可以评估当前的健康状况，并提供总体HRQL9的估计值。EQ-5D-3L由五个维度组成，涵盖了一个人健康的各个方面（流动性，自我护理，日常活动，疼痛/不适和焦虑/抑郁）。

Table 1 Demographics, clinical characteristics, and comparison between AF and no AF.Full size tableHRQL in people with T2DMThe mean EQ-5D-3L VAS and TTO index value was 71.9 ± 18.4 and 0.85 ± 0.21, respectively. The highest mean scores were seen in the pain/discomfort (1.70 ± 0.61) and mobility (1.28 ± 0.47) dimensions, whereas the lowest mean score was detected in the self-care (1.05 ± 0.21) dimension (Table 2).

表1人口统计学，临床特征以及房颤与非房颤之间的比较。T2DM患者的全尺寸表HRQL平均EQ-5D-3L VAS和TTO指数值分别为71.9±18.4和0.85±0.21。疼痛/不适（1.70±0.61）和活动度（1.28±0.47）维度的平均得分最高，而自我护理（1.05±0.21）维度的平均得分最低（表2）。

A high proportion of people with T2DM reported moderate and extreme problems in the pain/discomfort dimension in comparison to the other dimensions (Fig. 1). The anxiety/depression dimension was the only dimension to show a significant difference between males and females (1.20 ± 0.49 vs. 1.34 ± 0.55, p = 0.043, d = −0.269) (Supplementary Table 2)..

与其他维度相比，高比例的T2DM患者报告了疼痛/不适维度的中度和极端问题（图1）。焦虑/抑郁维度是唯一显示男性和女性之间显着差异的维度（1.20±0.49比1.34±0.55，p=0.043，d=0.269）（补充表2）。。

Table 2 Mean scores of the EQ-5D-3L questionnaire.Full size tableFig. 1Distribution of the EQ-5D-3L dimensions in people with T2DM presenting with advanced fibrosis (AF) or without advanced fibrosis (no AF). The EQ-5D-3L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

表2 EQ-5D-3L问卷的平均得分。全尺寸表图。1患有晚期纤维化（AF）或无晚期纤维化（无AF）的T2DM患者的EQ-5D-3L维度分布。EQ-5D-3L由五个维度组成：流动性，自我护理，日常活动，疼痛/不适和焦虑/抑郁。

Each of these dimensions is divided into three levels of perceived problems: no problems, moderate problems, or extreme problems.Full size imageComparison of the HRQL between AF and without AFThe HRQL was overall lower in AF (VAS: no AF 74.8 ± 16.4 vs. AF 59.9 ± 21.3, p < 0.001, d = 0.784; TTO: no AF 0.88 ± 0.17 vs.

这些维度中的每一个都分为三个层面的感知问题：无问题，中等问题或极端问题。房颤和无房颤后HRQL的全尺寸图像比较房颤患者的HRQL总体较低（VAS：无房颤74.8±16.4 vs.房颤59.9±21.3，p<0.001，d=0.784；TTO：无AF 0.88±0.17 vs。

AF 0.71 ± 0.29, p = 0.001, d = 0.715). Significantly higher mean scores for mobility (1.55 ± 0.57, p = 0.001, d = −0.665), usual activities (1.34 ± 0.48, p = 0.032, d = −0.397), and pain/discomfort (1.93 ± 0.65, p = 0.027, d = −0.467) dimensions were seen in those with AF (Table 2). Although the mean score of the anxiety/depression dimension was higher in AF, no significant difference was seen in the comparison to those without AF.

AF 0.71±0.29，p=0.001，d=0.715）。活动能力的平均得分（1.55±0.57，p=0.001，d=0.665），日常活动（1.34±0.48，p=0.032，d=0.397）和疼痛/不适（1.93±0.65，p=0.027，d AF患者的尺寸为0.467（表2）。虽然房颤患者焦虑/抑郁维度的平均得分较高，但与无房颤患者相比，没有显着差异。

In the pain/discomfort and mobility dimensions, more individuals with AF reported moderate and extreme problems compared to no AF. Furthermore, those with AF showed the second-highest distribution of extreme problems in the anxiety/depression dimension (Fig. 2). In addition, a comparison between people with T2DM presenting with SLD and without SLD and/or obesity is shown in Supplementary Table 3 and Supplementary Table 4, respectively.Fig.

在疼痛/不适和活动性方面，与没有房颤相比，更多的房颤患者报告了中度和极端问题。此外，房颤患者在焦虑/抑郁方面表现出第二高的极端问题分布（图2）。此外，补充表3和补充表4分别显示了患有SLD和无SLD和/或肥胖的T2DM患者之间的比较。图。

2Distribution of the EQ-5D-3L dimensions in people with T2DM in the entire cohort. The EQ-5D-3L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of these dimensions is divided into three levels of perceived .

2整个队列中T2DM患者EQ-5D-3L维度的分布。EQ-5D-3L由五个维度组成：流动性，自我护理，日常活动，疼痛/不适和焦虑/抑郁。这些维度中的每一个都分为三个感知层面。

Table 3 Clinical predictors of impaired HRQL in T2DM according to TTO index value.Full size tableTable 4 Clinical predictors of impaired HRQL in T2DM according to VAS.Full size tableSimilar results were seen with the VAS. Here, the variables obesity, waist circumference, MetS, AF, CVD, polyneuropathy, DFS, and insulin were associated with a lower HRQL.

表3根据TTO指数值，T2DM HRQL受损的临床预测因子。全尺寸表表4根据VAS，T2DM患者HRQL受损的临床预测因子。VAS可以看到完整的表相似的结果。。

Age (β: −0.171; 95% CI −0.369, −0.003), obesity (β: −0.247; 95% CI −0.419, -0.077), and AF (β: −0.222; 95% CI −0.383, −0.051) remained the only independent predictors a poor HRQL in the multivariable linear regression analysis (Table 4).DiscussionIn this study, we aimed to analyze the effect size of AF on the HRQL in people with T2DM in primary care in the German DMP using the EQ-5D-3L questionnaire.

年龄（β：-0.171；95%CI-0.369，-0.003），肥胖（β：-0.247；95%CI-0.419，-0.077）和房颤（β：-0.222；95%CI-0.383，-0.051）仍然是多变量线性回归分析中HRQL较差的唯一独立预测因子（表4）。讨论在这项研究中，我们旨在使用EQ-5D-3L问卷分析德国DMP初级保健中T2DM患者房颤对HRQL的影响大小。

Overall, the burden of liver-related comorbidities, including SLD and AF, is high in these individuals with a significant impact on the HRQL. The mobility and pain/discomfort dimensions imposed the highest burden. Especially those with AF showed the lowest scores on the VAS and the TTO index value. Although the presence of T2DM-related comorbidities was in part negatively affecting the HRQL, AF, and obesity remained the only independent predictors of an impaired HRQL in this cohort.

总体而言，这些个体的肝脏相关合并症（包括SLD和AF）的负担很高，对HRQL有重大影响。流动性和疼痛/不适维度带来了最高的负担。尤其是房颤患者的VAS和TTO指数得分最低。尽管T2DM相关合并症的存在在一定程度上对HRQL产生了负面影响，但房颤和肥胖仍然是该队列中HRQL受损的唯一独立预测因子。

Thus, obesity and more advanced liver disease may impose a higher impairment of HRQL than other well-known T2DM-related side effects. This has important implications for the consideration of SLD/MASLD and AF in the routine assessment of people with T2DM in disease management programs.Obesity and AF remained the only independent predictors of HRQL impairment as measured by the VAS and the TTO index value in this cohort.

因此，肥胖和更晚期的肝病可能比其他众所周知的T2DM相关副作用对HRQL产生更高的损害。这对于在疾病管理计划中对T2DM患者进行常规评估时考虑SLD/MASLD和AF具有重要意义。肥胖和房颤仍然是该队列中VAS和TTO指数值测量的HRQL损伤的唯一独立预测因子。

Other studies have also reported the negative impact of higher fibrosis stages, including AF, on the HRQL in patients with MASLD10.

其他研究也报道了包括房颤在内的较高纤维化阶段对MASLD10患者HRQL的负面影响。

Data availability

数据可用性

The data presented in this study are available on request from the corresponding author.

本研究中提供的数据可应通讯作者的要求提供。

AbbreviationsSLD:

快捷方式SLD：

Steatotic liver disease

脂肪变性肝病

MASLD:

马斯德：

Metabolic dysfunction-associated steatotic liver disease

代谢功能障碍相关的脂肪变性肝病

MASH:

糖浆：

Metabolic dysfunction-associated steatohepatitis

AF:

自动对焦：

Advanced fibrosis

晚期纤维化

T2DM:

Type 2 diabetes mellitus

2型糖尿病

MetS:

METS：

Metabolic syndrome

代谢综合征

NITs:

NITs：

Non-invasive tests

非侵入性测试

VCTE:

VCTE：

Vibration-controlled transient elastography

振动控制瞬态弹性成像

HRQL:

HRQL:

Health-related quality of life

与健康相关的生活质量

DMP:

DMP：

Disease management program

疾病管理计划

BMI:

体重指数：

Body mass index

体重指数

AUDIT:

审核：

Alcohol use disorders identification test

酒精使用障碍识别测试

HS:

HS：

Hepatic steatosis

肝脂肪变性

CAP:

上限：

Controlled attenuation parameter

受控衰减参数

LSM:

LSM：

Liver stiffness measurement

肝脏硬度测量

TTO:

TTO公司：

Time trade-off

时间权衡

VAS:

增值税：

Visual analog scale

视觉模拟刻度

CVD:

心血管疾病：

Cardiovascular disease

心血管疾病

CKD:

CKD公司：

Chronic kidney disease

慢性肾脏疾病

DFS:

DFS（DFS）：

Diabetic foot syndrome

糖尿病足综合征

GGT:

GGT：

Gamma-glutamyl transferase

γ-谷氨酰转移酶

TG:

甘油三酯：

Triglycerides

甘油三酯

TC:

技术委员会：

Total cholesterol

总胆固醇

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Download referencesAcknowledgementsMM was supported by the Clinician Scientist Fellowship “Else Kröner Research College: 2018_Kolleg.05”. This study contains parts of the medical thesis of MD (Michelle Doll). We thank all the patients that participated in this study.FundingOpen Access funding enabled and organized by Projekt DEAL.Author informationAuthors and AffiliationsDepartment of Internal Medicine II, University Medical Centre Saarland, Homburg, GermanyMaurice Michel & Jörn M.

下载参考文献致谢SMM得到了临床医生科学家奖学金“Else Kröner Research College:2018\u Kolleg.05”的支持。这项研究包含MD（Michelle Doll）医学论文的部分内容。我们感谢所有参与这项研究的患者。资金开放获取资金由Projekt交易启用和组织。作者信息作者和附属机构德国洪堡萨尔大学医学中心内科II系Maurice Michel＆Jörn M。

SchattenbergDepartment of Internal Medicine I, University Medical Centre Mainz, Mainz, GermanyMaurice Michel, Jesús Funuyet-Salas, Michelle Doll, Angelo Armandi, Christian Labenz, Peter R. Galle & Jörn M. SchattenbergLoyola University Andalusia, Sevilla, SpainJesús Funuyet-SalasLiver Transplantation Center, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi ArabiaSaleh A.

Schattenberg美因茨大学医学中心第一内科，美因茨，GermanyMaurice Michel，Jesús Funuyet Salas，Michelle Doll，Angelo Armandi，Christian Labenz，Peter R.Galle＆Jörn M.SchattenbergLoyola大学安达卢西亚，塞维利亚，SpainJesús Funuyet SalasLiver移植中心，沙特利雅得费萨尔国王专科医院和研究中心。

AlqahtaniDivision of Gastroenterology and Hepatology, Johns Hopkins University, Baltimore, MD, USASaleh A. AlqahtaniDepartment of Medical Sciences, University of Turin, Turin, ItalyAngelo ArmandiSaarland University, Saarbrücken, GermanyJörn M. SchattenbergAuthorsMaurice MichelView author publicationsYou can also search for this author in.

AlqahtaniDivision of Gastroenterology and Hepatology，Johns Hopkins University，Baltimore，MD，USASaleh A.AlqahtaniDivision of Medical Sciences，都灵大学，都灵，意大利安杰洛·阿曼德萨尔兰大学，萨尔布吕肯，GermanyJörn M.SchattenbergAuthorsMaurice MichelView author Publications你也可以在中搜索这位作者。

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PubMed Google ScholarContributionsPerformed research: MM, MD. Contributed to acquisition of data: MM, MD, AA, CL, JMS; Designed the experiments and analyzed the data: MM, JMS; Contributed reagents/materials/analysis tools: PRG, JMS. Wrote the manuscript: MM, JMS. Revised and edited the manuscript: MM, JFS, SAA, AA, CL, PRG, JMS.

PubMed谷歌学术贡献形式研究：MM，MD。有助于获取数据：MM，MD，AA，CL，JMS；设计实验并分析数据：MM，JMS；贡献的试剂/材料/分析工具：PRG，JMS。写了手稿：MM，JMS。修订并编辑了手稿：MM，JFS，SAA，AA，CL，PRG，JMS。

Statistical analysis: MM, JFS, JMS. All authors approved the final version of the manuscript and the authorship list. Guarantor of the article: JMS.Corresponding authorCorrespondence to.

统计分析：MM，JFS，JMS。所有作者都批准了手稿的最终版本和作者名单。文章担保人：JMS。对应作者对应。

Jörn M. Schattenberg.Ethics declarations

Jörn M.Schattenberg。道德宣言

Competing interests

相互竞争的利益

JMS reports Consultant: Apollo Endosurgery, Albireo Pharma Inc, Bayer, BMS, Boehringer Ingelheim, Echosens, Genfit, Gilead Sciences, GSK, Heel GmbH, Intercept Pharmaceuticals, Ipsen, Inventiva Pharma, Julius Clinical, Madrigal, MSD, Nordic Bioscience, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Shinogi, Siemens Healthcare GmbH, Summit Clinical Research.

JMS报告顾问：Apollo Endosurgy，Albireo Pharma Inc，Bayer，BMS，Boehringer Ingelheim，Echosens，Genfit，Gilead Sciences，GSK，Heel GmbH，Intercept Pharmaceuticals，Ipsen，Inventiva Pharma，Julius Clinical，Madrigal，MSD，Nordic Bioscience，Novartis，Novo Nordisk，Pfizer，Roche，Sanofi，Shinogi，Siemens Healthcare GmbH，Summit Clinical Research。

Research Funding: Gilead Sciences, Boehringer Ingelheim, Nordic Bioscience, Siemens Healthcare GmbH. Speaker Honorarium: MedPublico GmbH, Boehringer Ingelheim. The other authors declare that they have no competing interests..

研究资金：吉利德科学公司，勃林格殷格翰公司，北欧生物科学公司，西门子医疗保健有限公司。荣誉发言人：MedPublico GmbH，勃林格殷格翰公司。其他作者声明他们没有利益冲突。。

Ethics approval and consent to participate

道德批准和同意参与

Informed consent was obtained from all participants involved in the study.

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Reprints and permissionsAbout this articleCite this articleMichel, M., Funuyet-Salas, J., Doll, M. et al. Impairment of health-related quality of life among people with type 2 diabetes and advanced liver fibrosis.

转载和许可本文引用本文Michel，M.，Funuyet-Salas，J.，Doll，M。等人。2型糖尿病和晚期肝纤维化患者健康相关生活质量的损害。

Sci Rep 14, 21650 (2024). https://doi.org/10.1038/s41598-024-72105-8Download citationReceived: 20 July 2024Accepted: 03 September 2024Published: 17 September 2024DOI: https://doi.org/10.1038/s41598-024-72105-8Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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KeywordsMASLDAdvanced fibrosisT2DMObesityHRQL

关键词MASL晚期纤维化T2DM肥胖HRQL

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