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Diagnostic delay and cardiovascular complications in Takayasu arteritis: a case-based review. 高须动脉炎的诊断延迟和心血管并发症:一项基于病例的回顾。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-13 DOI: 10.1007/s00296-025-06001-3
Gulmira Seitzhanova, Darkhan Suigenbayev, Akerke Auanassova

Takayasu arteritis (TA) is a rare systemic inflammatory disease affecting medium and large arteries, mainly in young Asian women, with a frequency of 1-3 cases per million inhabitants. Diagnosing this disease is challenging due to nonspecific early symptoms, leading to gradual clinical progression until vascular complications appear. A 21-year-old pregnant woman, experiencing progressive mild fatigue, referred for clinical examination. Over the past 3-4 years, she had reported weakness, headache, sweating, and dizziness. Imaging revealed significant vascular damage, including an ascending aortic aneurysm, aortic valve annuloaortic ectasia, aortic, mitral, tricuspid, and pulmonary regurgitation, as well as dilation of the left atrium and left ventricle. While available treatments alleviated symptoms and slowed the progression, late diagnosis resulted in lifelong illness. The diagnostic challenges associated with nonspecific early symptoms and the risk of serious vascular complications underscore the importance of early detection of TA in young women with symptoms of systemic inflammation. Women with TA are more likely to have an unfavourable pregnancy outcomes than the general population. Therefore, such patients need careful monitoring and a collaborative approach to achieve the best possible delivery results. This report aims to compile information on pregnancy in women with TA and how the disease impacts pregnancy progression.

高松动脉炎(Takayasu arteritis, TA)是一种罕见的影响中大动脉的全身性炎症性疾病,主要发生在年轻的亚洲女性中,发病率为每百万居民1-3例。由于早期症状非特异性,该病的诊断具有挑战性,临床进展缓慢,直至出现血管并发症。21岁孕妇,进行性轻度疲劳,转介临床检查。在过去的3-4年里,她有虚弱、头痛、出汗和头晕的症状。影像学显示明显的血管损伤,包括升主动脉瘤、主动脉瓣环主动脉扩张、主动脉瓣、二尖瓣、三尖瓣和肺反流,以及左心房和左心室扩张。虽然现有的治疗方法减轻了症状并减缓了进展,但晚期诊断导致终身疾病。与非特异性早期症状和严重血管并发症风险相关的诊断挑战强调了早期发现系统性炎症症状的年轻女性TA的重要性。与一般人群相比,患有TA的女性更有可能出现不利的妊娠结局。因此,这些患者需要仔细监测和合作的方法,以达到最佳的交付结果。本报告旨在收集有关TA患者的妊娠信息以及该疾病如何影响妊娠进展。
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引用次数: 0
New versus old: comparison of the 2022 ACR/EULAR versus the 1990 ACR classification criteria for giant cell arteritis in a real-world cohort. 新与旧:2022年ACR/EULAR与1990年ACR巨细胞动脉炎分类标准在现实世界队列中的比较
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-13 DOI: 10.1007/s00296-025-05965-6
Raoul Bergner, C Löffler, P Schulz, D Klank, J Friedrich
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引用次数: 0
Gout disease-related years lived with disability in the North Africa and Middle East countries: a systematic analysis of the GBD study 1990-2019. 北非和中东国家痛风疾病相关的残疾生活年数:对1990-2019年GBD研究的系统分析
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-13 DOI: 10.1007/s00296-025-06006-y
Moloud Payab, Sahar Saeedi Moghaddam, Yasaman Sharifi, Farshad Sharifi, Mahbube Ebrahimpur, Alireza Hadizadeh, Zahra Esfahani, Pouya Ebrahimi, Pedram Ramezani, Zahra Hoseini Tavassol, Ali Ghanbari, Parnian Shobeiri, Zeinab Shirzad Moghaddam, Rosa Haghshenas, Elham Abdolhamidi, Ameneh Kazemi, Arezou Dilmaghani-Marand, Bagher Larijani

The purpose of this study is to describe the changes in the age-standardized prevalence rate, incidence rate, and years lived with disability (YLDs) rate for gout disease and the associated risk factors in 21 North Africa and Middle East (NAME) countries from 1990 to 2019 based on age, gender, and socio-demographic index (SDI). From 1990 to 2019, the Global Burden of Disease (GBD) team performed a comprehensive systematic review of databases and disease-modeled analysis in the NAME countries. Age-standardized prevalence, incidence, and YLD rates, as well as the attributed burden to risk factors (high body mass index (BMI) and kidney dysfunction), were reported with 95% uncertainty intervals (UIs). The age-standardized YLDs estimated in 2019 and 1990 were 14.2 (95% UI 8.9-20.4) and 15.8 (10.0-22.7) per 100,000 populations, respectively, with an increase of 11.7% (7.1-16.4%) from 1990. The health indicators were all reported to be higher among males. The three countries with higher SDI that had the highest age-standardized YLDs rate in 2019 were Qatar (22.5 [14.5-32.7]), the United Arab Emirates (20.5 [12.9-29.9]), and Kuwait (19.0 [11.7-27.6]), while YLDs in 2019 attributable to high BMI and kidney dysfunction were estimated to be 7.2 (3.8-12.2) and 3.7 (2.3-5.5) per 100,000, respectively. According to our findings, the burden of gout in the NAME is higher than the reported global average and has risen from 1990 to 2019. Despite advances in gout treatment, NAME countries should prioritize preventive interventions to manage the disease's burden. Gout is the most common type of inflammatory arthropathy, and there have been no specific reports of this disease burden in the NAME countries, which account for nearly 8% of the global population. This report estimated that age-standardized YLDs increased by 11.7% (7.1%-16.4%) from 1990 to 2019 in this region. Consequently, these countries have to prioritize preventive interventions to manage the disease's burden.

本研究的目的是基于年龄、性别和社会人口指数(SDI),描述1990年至2019年21个北非和中东(NAME)国家痛风疾病的年龄标准化患病率、发病率和残疾年数(YLDs)率及其相关危险因素的变化。从1990年到2019年,全球疾病负担(GBD)团队对NAME国家的数据库和疾病模型分析进行了全面的系统审查。年龄标准化患病率、发病率和YLD率,以及归因于危险因素(高体重指数(BMI)和肾功能障碍)的负担,以95%的不确定区间(UIs)进行报告。2019年和1990年估计的年龄标准化YLDs分别为每10万人14.2 (95% UI 8.9-20.4)和15.8(10.0-22.7),比1990年增加11.7%(7.1-16.4%)。据报告,男性的健康指标都较高。2019年年龄标准化YLDs率最高的三个SDI较高的国家是卡塔尔(22.5[14.5-32.7])、阿拉伯联合酋长国(20.5[12.9-29.9])和科威特(19.0[11.7-27.6]),而2019年归因于高BMI和肾功能障碍的YLDs估计分别为每10万人7.2(3.8-12.2)和3.7(2.3-5.5)。根据我们的研究结果,痛风的负担高于报告的全球平均水平,并且从1990年到2019年有所上升。尽管痛风治疗取得了进展,但金砖国家应优先采取预防性干预措施,以控制该病的负担。痛风是最常见的炎性关节病类型,在占全球人口近8%的“金砖国家”中,没有关于这种疾病负担的具体报告。该报告估计,从1990年到2019年,该地区年龄标准化YLDs增长了11.7%(7.1%-16.4%)。因此,这些国家必须优先采取预防性干预措施,以管理该病的负担。
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引用次数: 0
Evaluation of central sensitization and associated factors in systemic lupus erythematosus: a cross-sectional study. 评价系统性红斑狼疮的中枢致敏和相关因素:一项横断面研究。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-13 DOI: 10.1007/s00296-025-05997-y
Ayşegül Yetişir, Elif Altunel Kılınç, Gülin Hüda Gedik, Volkan Deniz, İpek Türk, Gülşah Yaşa Öztürk

To examine the central sensitization and its determinants in systemic lupus erythematosus (SLE) and compare it with psoriatic arthritis (PsA) and healthy controls (HC). We evaluated the sociodemographic and disease-related parameters, and administered to the study groups the Brief Illness Perception Questionnaire (B-IPQ), the Fatigue Severity Scale (FSS), the Jenkins Sleep Evaluation Scale (JSS), the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the Central Sensitization Inventory (CSI). We also measured pain using the visual analog scale (VAS) (0-10 cm). This study included age- and gender-matched SLE (n = 74), PsA (n = 74), and HC (n = 80) groups. The JSS, FSS, and CSI scores were higher in SLE than in HC. Although tender joint count, swollen joint count, VAS, and HAQ-DI scores were statistically higher in the PsA group compared to the SLE group, the central sensitization rates in the two groups were similar (56.7% for SLE and 55.4% for PsA, p = 0.868). CSI was significantly correlated with the number of tender joints, VAS, HAQ-DI, B-IPQ, JSS, and FSS (Spearman's rho ranged from 0.501 to 0.646) in SLE. FSS, JSS, and tender joint count were the most important predictors of CSI. Age, the number of swollen and tender joints, FSS, B-IPQ, and JSS accounted for 74% of the variation in CSI scores in SLE. Psychosocial variables influence central sensitization, which occurs frequently in SLE. SLE and PsA exhibited similar CSI scores but higher than HC. It is beneficial to evaluate and manage central sensitization in SLE patients with fatigue and sleep disorders.

探讨系统性红斑狼疮(SLE)的中枢致敏及其决定因素,并与银屑病关节炎(PsA)和健康对照(HC)进行比较。我们评估了社会人口学和疾病相关参数,并对研究组进行了简短疾病感知问卷(B-IPQ)、疲劳严重程度量表(FSS)、詹金斯睡眠评估量表(JSS)、健康评估问卷-残疾指数(HAQ-DI)和中心敏感化量表(CSI)。我们还使用视觉模拟量表(VAS) (0-10 cm)测量疼痛。本研究包括年龄和性别匹配的SLE (n = 74)、PsA (n = 74)和HC (n = 80)组。SLE患者的JSS、FSS和CSI评分高于HC患者。虽然PsA组的压痛关节计数、肿胀关节计数、VAS和HAQ-DI评分在统计学上高于SLE组,但两组的中枢致敏率相似(SLE为56.7%,PsA为55.4%,p = 0.868)。SLE患者的CSI与压痛关节数、VAS、HAQ-DI、B-IPQ、JSS、FSS呈显著相关(Spearman’s rho范围为0.501 ~ 0.646)。FSS、JSS和压痛关节数是CSI最重要的预测因子。年龄、肿胀和压痛关节的数量、FSS、B-IPQ和JSS占SLE CSI评分变化的74%。社会心理变量影响中枢致敏,这在SLE中经常发生。SLE和PsA的CSI评分相似,但高于HC。评估和管理伴有疲劳和睡眠障碍的SLE患者的中枢致敏是有益的。
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引用次数: 0
"My world has shrunk": a mixed-methods exploration of the impact of systemic autoimmune rheumatic diseases on patients' lives. “我的世界缩小了”:对系统性自身免疫性风湿病对患者生活影响的混合方法探索。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-10 DOI: 10.1007/s00296-025-05993-2
Martha A Piper, Alice Tunks, Sean Humfrey, Lucy Calderwood, Shaista Tayabali, Sydnae Taylor, Arvind Kaul, Ellie Dalby, Shihab Ahmed, Sue Farrington, Thomas A Pollak, Melanie Sloan
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引用次数: 0
Adjuvant-induced autoimmune syndrome (ASIA syndrome) and the role of sonography in its diagnosis: a case-based review. 佐剂诱导的自身免疫综合征(ASIA综合征)和超声在其诊断中的作用:一项基于病例的回顾。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-08 DOI: 10.1007/s00296-025-05954-9
Lyatif Masar Kodzhaahmed, Elis Korudova, Konstantin Batalov, Dimitrina Petrova, Zguro Batalov

Adjuvant-induced autoimmune/ autoinflammatory syndrome (ASIA) is a group of symptoms that are often found in other systemic, autoimmune diseases, which makes its recognition and diagnosis a growing problem in modern clinical practice. Although not completely clear, the genesis is associated with adjuvants - substances found in implants, vaccines, substances external to the body that lead to an exaggerated immune response. Key points of the clinical and paraclinical specificity of the disease are arthralgias, myalgias, cognitive disorders, and positivity of various autoimmune and inflammatory markers. The objectives of this report are to summarize current information about the disease, discuss diagnostic criteria, and review therapeutic options, placing special interest on the ultrasound findings. The presented case outlines the diagnostic difficulty even with the various clinical, imaging, and laboratory findings. Directing clinical thought towards this syndrome is of utmost importance for its easier recognition in practice and achieving favorable outcomes in the treatment of affected patients.

佐剂诱导的自身免疫/自身炎症综合征(佐剂诱导的自身免疫/自身炎症综合征,ASIA)是一组常见于其他系统性自身免疫性疾病的症状,使其识别和诊断成为现代临床实践中日益突出的问题。虽然尚不完全清楚,但其起源与佐剂有关,即植入物、疫苗中发现的物质,以及体外导致过度免疫反应的物质。该疾病的临床和临床旁特异性的关键点是关节痛、肌痛、认知障碍和各种自身免疫和炎症标志物的阳性。本报告的目的是总结目前有关该病的信息,讨论诊断标准,并审查治疗方案,特别关注超声检查结果。本病例概述了诊断困难,即使有各种临床,影像学和实验室结果。指导临床思想对这种综合征是至关重要的,因为它在实践中更容易识别,并在治疗患者时取得良好的结果。
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引用次数: 0
Rheumatoid arthritis is independently associated with metabolic Dysfunction-Associated steatotic liver disease: evidence from the paracelsus 10,000 Population-Based cohort study. 类风湿关节炎与代谢功能障碍相关的脂肪变性肝病独立相关:来自paracelsus 10,000人群队列研究的证据
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-06 DOI: 10.1007/s00296-025-06002-2
Mathias Ausserwinkler, Axel J Hueber, Sophie Gensluckner, Bernhard Paulweber, Eugen Trinka, Patrick Langthaler, Christian Datz, Andreas Voelkerer, Franz Singhartinger, Bernhard Iglseder, Maria Flamm, Elmar Aigner, Bernhard Wernly

Background: Rheumatoid arthritis (RA) is associated with systemic inflammation and increased risk of cardiovascular and metabolic comorbidities. The relationship between RA and metabolic dysfunction-associated steatotic liver disease (MASLD) has not been established in population-based studies.

Methods: We conducted a cross-sectional analysis of 6638 participants from the population-based Paracelsus 10,000 cohort in Austria, including 187 individuals with physician-diagnosed RA meeting ACR/EULAR classification criteria. MASLD was defined using the Fatty Liver Index (≥ 60) combined with cardiometabolic risk factors according to 2024 EASL guidelines. We used Poisson regression models with sequential adjustment for demographic factors, metabolic syndrome, lifestyle factors, NSAID use, and cardiovascular risk (SCORE2). Liver fibrosis risk was assessed using the Fibrosis-4 Index (FIB-4).

Results: MASLD prevalence was higher in RA patients than controls (41.2% vs. 28.5%, P < 0.001). In sequential regression models, the association between RA and MASLD persisted after adjustment for demographics (IRR, 1.55; 95% CI 1.33-1.82), metabolic and lifestyle factors (IRR, 1.20; 95% CI 1.03-1.40), and cardiovascular risk factors (IRR, 1.35; 95% CI 1.14-1.60; P < 0.001). In addition, RA patients showed elevated liver fibrosis markers (median FIB-4: 1.21 vs. 1.08; P < 0.001).

Conclusions: In this population-based cohort, RA was independently associated with a 35% increased risk of MASLD and elevated liver fibrosis markers. These findings suggest that systematic liver assessment should be considered in the routine care of RA patients.

背景:类风湿性关节炎(RA)与全身性炎症以及心血管和代谢合并症的风险增加有关。RA与代谢功能障碍相关的脂肪变性肝病(MASLD)之间的关系尚未在基于人群的研究中得到证实。方法:我们对6638名来自奥地利以人群为基础的Paracelsus 10,000队列的参与者进行了横断面分析,其中包括187名医生诊断为符合ACR/EULAR分类标准的RA患者。根据2024年EASL指南,使用脂肪肝指数(≥60)结合心脏代谢危险因素来定义MASLD。我们使用泊松回归模型,对人口统计学因素、代谢综合征、生活方式因素、非甾体抗炎药使用和心血管风险(SCORE2)进行顺序调整。采用纤维化-4指数(FIB-4)评估肝纤维化风险。结果:类风湿关节炎患者的MASLD患病率高于对照组(41.2% vs. 28.5%)。结论:在这个基于人群的队列中,类风湿关节炎与MASLD风险增加35%和肝纤维化标志物升高独立相关。这些发现提示在RA患者的常规护理中应考虑系统的肝脏评估。
{"title":"Rheumatoid arthritis is independently associated with metabolic Dysfunction-Associated steatotic liver disease: evidence from the paracelsus 10,000 Population-Based cohort study.","authors":"Mathias Ausserwinkler, Axel J Hueber, Sophie Gensluckner, Bernhard Paulweber, Eugen Trinka, Patrick Langthaler, Christian Datz, Andreas Voelkerer, Franz Singhartinger, Bernhard Iglseder, Maria Flamm, Elmar Aigner, Bernhard Wernly","doi":"10.1007/s00296-025-06002-2","DOIUrl":"10.1007/s00296-025-06002-2","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis (RA) is associated with systemic inflammation and increased risk of cardiovascular and metabolic comorbidities. The relationship between RA and metabolic dysfunction-associated steatotic liver disease (MASLD) has not been established in population-based studies.</p><p><strong>Methods: </strong>We conducted a cross-sectional analysis of 6638 participants from the population-based Paracelsus 10,000 cohort in Austria, including 187 individuals with physician-diagnosed RA meeting ACR/EULAR classification criteria. MASLD was defined using the Fatty Liver Index (≥ 60) combined with cardiometabolic risk factors according to 2024 EASL guidelines. We used Poisson regression models with sequential adjustment for demographic factors, metabolic syndrome, lifestyle factors, NSAID use, and cardiovascular risk (SCORE2). Liver fibrosis risk was assessed using the Fibrosis-4 Index (FIB-4).</p><p><strong>Results: </strong>MASLD prevalence was higher in RA patients than controls (41.2% vs. 28.5%, P < 0.001). In sequential regression models, the association between RA and MASLD persisted after adjustment for demographics (IRR, 1.55; 95% CI 1.33-1.82), metabolic and lifestyle factors (IRR, 1.20; 95% CI 1.03-1.40), and cardiovascular risk factors (IRR, 1.35; 95% CI 1.14-1.60; P < 0.001). In addition, RA patients showed elevated liver fibrosis markers (median FIB-4: 1.21 vs. 1.08; P < 0.001).</p><p><strong>Conclusions: </strong>In this population-based cohort, RA was independently associated with a 35% increased risk of MASLD and elevated liver fibrosis markers. These findings suggest that systematic liver assessment should be considered in the routine care of RA patients.</p>","PeriodicalId":21322,"journal":{"name":"Rheumatology International","volume":"45 10","pages":"243"},"PeriodicalIF":2.9,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12500724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145233490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction: Biopsychosocial model-based exercise improves muscle strength, proprioception, pain, function, and quality of life in rheumatoid arthritis patients with knee involvement: a randomized controlled clinical trial. 修正:一项随机对照临床试验:基于生物心理社会模型的运动改善膝关节受累的类风湿关节炎患者的肌肉力量、本体感觉、疼痛、功能和生活质量。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-06 DOI: 10.1007/s00296-025-05999-w
Ayşen Akgöz, Yavuz Yakut, Orkun Tüfekçi, Batuhan E Aktaş, Erkin O Sari, Aysima Barlak, Kezban Bayramlar, Şule Apraş Bilgen, Feza Korkusuz, Edibe Ünal
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引用次数: 0
Monitoring fracture risk during antiosteoporotic therapy: a retrospective cohort study. 在抗骨质疏松治疗期间监测骨折风险:一项回顾性队列研究。
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-10-06 DOI: 10.1007/s00296-025-05995-0
Mariya Nedkova, Tsvetanka Petranova, Rositsa Karalilova, Zguro Batalov

Osteoporosis is among the leading socially significant diseases, with potential for early diagnosis and effective treatment. Appropriate selection of therapy, particularly after reassessment of ongoing antiosteoporotic therapy, can reduce both fracture risk and healthcare system costs. To evaluate strategies for reassessing antiosteoporotic therapy on the grounds of changes in fracture risk among women in the Bulgarian population. We conducted a retrospective observational cohort study including 300 participants women with postmenopausal, senile osteoporosis or low-energy fractures undergoing antiresorptive therapy. Data were collected at the time of discharge and during a 1-year follow-up period, covering a total monitoring period of 3 years. The FRAX score based on hip fracture (HF), proved to be a more sensitive predictor of future fractures ( HF > 4.5% in 65.22% with postmenopausal osteoporosis and in 100% with senile). In the bisphosphonate treatment group, total bone mineral density (BMD) of the lumbar spine (VL) and BMD оf the femoral neck (FN) demonstrated a clearer trend of BMD improvement (month 36: 0.838 g/cm2 ± 0.01 SD and 0.622 g/cm2 ± 0.04 SD ) compared to T-scores. BMD -particularly of the FN-and FN T-scores in patients at very high fracture risk were significant indicators for therapy reassessment. BMD of the FN consistently predicted changes in fracture risk across all monitoring periods. Implementing national strategies for the reassessment of antiosteoporotic therapy, on the grounds of evolving fracture risk, could enhance clinical decision-making and address existing gaps in the treatment of high-risk patients.

骨质疏松症是主要的社会重大疾病之一,具有早期诊断和有效治疗的潜力。适当选择治疗方法,特别是在重新评估正在进行的抗骨质疏松治疗后,可以降低骨折风险和医疗保健系统成本。基于保加利亚妇女骨折风险的变化,评估重新评估抗骨质疏松治疗的策略。我们进行了一项回顾性观察队列研究,包括300名绝经后、老年性骨质疏松或低能量骨折接受抗吸收治疗的妇女。在出院时和1年随访期间收集数据,总监测期为3年。基于髋部骨折(HF)的FRAX评分被证明是一个更敏感的预测未来骨折的指标(65.22%的绝经后骨质疏松症患者HF为4.5%,老年患者为100%)。与t评分相比,双膦酸盐治疗组腰椎总骨密度(BMD)和股骨颈骨密度(FN)改善趋势更明显(第36个月:0.838 g/cm2±0.01 SD和0.622 g/cm2±0.04 SD)。骨密度,尤其是FN和FN t评分对于骨折风险非常高的患者是治疗再评估的重要指标。在所有监测期间,FN的骨密度一致地预测了骨折风险的变化。基于不断变化的骨折风险,实施重新评估抗骨质疏松治疗的国家战略,可以提高临床决策能力,解决高危患者治疗方面的现有差距。
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引用次数: 0
Scoping review of biosimilar disease-modifying antirheumatic drugs in pregnancy: evidence gaps and proposed outcome reporting framework. 妊娠期改善疾病的抗风湿药物生物类似药的范围审查:证据差距和建议的结果报告框架
IF 2.9 3区 医学 Q2 RHEUMATOLOGY Pub Date : 2025-09-29 DOI: 10.1007/s00296-025-05968-3
Vienna Cheng, Neda Amiri, Vicki Cheng, Ursula Ellis, Jacquelyn J Cragg, Laurie Proulx, Dwayne R Tucker, Mary A De Vera

Biologic disease-modifying antirheumatic drugs (DMARDs) have revolutionized the management of autoimmune diseases. Biosimilar DMARDs have emerged as highly similar, cost-efficient alternatives; however, the scope of their perinatal evidence remains unexplored. We conducted a scoping review to synthesize evidence on the impact of biosimilar DMARDs on pregnancy outcomes. We searched Embase, MEDLINE and CENTRAL databases in November 2023 and June 2025. Inclusion criteria were studies examining biosimilar DMARD exposure for autoimmune diseases in mothers during pregnancy, fathers prior to conception and/or fetuses/neonates in-utero. Data were extracted on sample size, study design, drug exposure (timing, duration), and pregnancy outcomes. Patterns in methodologic reporting across studies were also analyzed. Overall, 6 studies (5 descriptive, 1 cohort study) were eligible for inclusion. Biosimilars examined were tumor necrosis factor inhibitors (infliximab, n = 4; etanercept, n = 2; adalimumab, n = 1) and B-cell inhibitors (rituximab, n = 1) among 63 mothers with inflammatory bowel disease, rheumatoid arthritis, or ankylosing spondylitis. Twenty-four fetal/neonatal (i.e., congenital anomaly), fetal/neonatal-maternal (i.e., Caesarean-section, spontaneous abortion), and maternal (i.e., disease flare) outcomes were reported. For methodologic reporting, we observed inconsistencies in exposure and outcome measures. To enhance comparability and standardization, we encourage the use of our Reproductive Health Outcomes Reporting Framework. Our scoping review is the first synthesis of perinatal evidence to date on biosimilar DMARDs. Critical gaps include an overall limited number of studies and a lack of analytical research that evaluate associations between exposures and outcomes. These findings highlight key evidence gaps in understanding the perinatal impacts of these emerging drugs.

生物疾病改善抗风湿药物(DMARDs)已经彻底改变了自身免疫性疾病的管理。生物类似药dmard已经成为高度相似、成本效益高的替代品;然而,他们的围产期证据的范围仍未被探索。我们进行了一项范围综述,以综合生物类似药dmard对妊娠结局影响的证据。我们在2023年11月和2025年6月检索了Embase、MEDLINE和CENTRAL数据库。纳入标准是检查怀孕期间母亲、孕前父亲和/或胎儿/子宫内新生儿自身免疫性疾病的生物类似药DMARD暴露的研究。数据包括样本量、研究设计、药物暴露(时间、持续时间)和妊娠结局。还分析了各研究的方法学报告模式。总共有6项研究(5项描述性研究,1项队列研究)符合纳入条件。在63名患有炎症性肠病、类风湿关节炎或强直性脊柱炎的母亲中,研究的生物类似药是肿瘤坏死因子抑制剂(英夫利昔单抗,n = 4;依那西普,n = 2;阿达木单抗,n = 1)和b细胞抑制剂(利妥昔单抗,n = 1)。报告了24例胎儿/新生儿(即先天性异常)、胎儿/新生儿-产妇(即剖腹产、自然流产)和产妇(即疾病爆发)结局。对于方法学报告,我们观察到暴露和结果测量的不一致。为了加强可比性和标准化,我们鼓励使用我们的生殖健康成果报告框架。我们的范围综述是迄今为止关于生物仿制药dmard的围产期证据的首次综合。关键的差距包括总体上研究数量有限,以及缺乏评估暴露与结果之间关系的分析性研究。这些发现突出了在理解这些新兴药物对围产期影响方面的关键证据差距。
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引用次数: 0
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Rheumatology International
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