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Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial. 一种新型合成仿生支架用于骨盆带痛手术治疗中髂骨缺损重建的安全性和性能:首次人体试验。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2025-01-16 DOI: 10.1093/bmb/ldae023
Peter V Giannoudis, Paul Andrzejwski, George Chloros, Elizabeth M A Hensor

Introduction: Surgical treatment of pelvic girdle pain (PGP) involves arthrodesis of sacroiliac (SI) and pubic symphysis joints. Fusion of pubic symphysis involves the implantation of an autologous iliac crest tricortical graft harvested from the iliac crest. The objective was to assess the safety of a novel synthetic graft substitute (b.Bone) for iliac crest reconstruction and to evaluate the results of PGP surgical treatment.

Sources of data: Consecutive participants undergoing pelvic fusion and requiring iliac crest reconstruction were enrolled and followed-up for 12 months in a prospective first-in-human clinical investigation. Adverse events were documented, and health-related quality of life was evaluated using EuroQol-5D-5L questionnaire. Iliac crest defect healing was evaluated by the Modified Lane and Sandhu radiological scoring system. In addition, relevant published peer-reviewed scientific articles identified from PubMed.

Areas of agreement: The EQ-5D-5L scores improved steadily reaching the highest point at 365 days. By 365 days complete healing of the bone defect was observed.

Areas of controversy: The management of PGP remains challenging with mixed results reported in the literature.

Growing points: While there is lack of consensus on how to manage PGP, the present study shows improved outcomes at one year following surgery. The synthetic b.Bone scaffold is a safe option with good healing outcomes for iliac crest defect reconstruction.

Areas timely for developing research: Although b.Bone synthetic scaffold found to be safe, further studies reporting on surgical treatment of PGP are required to confirm the findings in comparative trials.

导言:骨盆带痛(PGP)的手术治疗涉及骶髂(SI)和耻骨联合关节的关节融合术。耻骨联合融合包括从髂骨上取下的自体髂骨三皮质移植物。目的是评估一种新型合成移植物替代物(b.Bone)用于髂骨重建的安全性,并评估PGP手术治疗的结果。数据来源:在一项前瞻性的首次人体临床研究中,连续接受骨盆融合和需要髂骨重建的参与者被招募并随访了12个月。记录不良事件,并使用EuroQol-5D-5L问卷评估与健康相关的生活质量。采用改良Lane和Sandhu放射评分系统评价髂嵴缺损愈合情况。此外,从PubMed中确定的相关已发表的同行评审的科学文章。一致领域:EQ-5D-5L评分稳步提高,在365天达到最高点。365天观察到骨缺损完全愈合。争议领域:PGP的管理仍然具有挑战性,文献报道的结果好坏参半。成长要点:虽然在如何处理PGP方面缺乏共识,但目前的研究表明,手术后一年的结果有所改善。人工骨支架是髂嵴缺损重建的一种安全的选择,具有良好的愈合效果。需要及时开展研究的领域:虽然b.骨合成支架被发现是安全的,但需要进一步的研究报道PGP的手术治疗,以在比较试验中证实这些发现。
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引用次数: 0
Physicians' required competencies in AI-assisted clinical settings: a systematic review. 医生在人工智能辅助临床环境中所需的能力:系统回顾。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2025-01-16 DOI: 10.1093/bmb/ldae025
Lotte Schuitmaker, Jojanneke Drogt, Manon Benders, Karin Jongsma

Background: Utilizing Artificial Intelligence (AI) in clinical settings may offer significant benefits. A roadblock to the responsible implementation of medical AI is the remaining uncertainty regarding requirements for AI users at the bedside. An overview of the academic literature on human requirements for the adequate use of AI in clinical settings is therefore of significant value.

Sources of data: A systematic review of the potential implications of medical AI for the required competencies of physicians as mentioned in the academic literature.

Areas of agreement: Our findings emphasize the importance of physicians' critical human skills, alongside the growing demand for technical and digital competencies.

Areas of controversy: Concrete guidance on physicians' required competencies in AI-assisted clinical settings remains ambiguous and requires further clarification and specification. Dissensus remains over whether physicians are adequately equipped to use and monitor AI in clinical settings in terms of competencies, skills and expertise, issues of ownership regarding normative guidance, and training of physicians' skills.

Growing points: Our review offers a basis for subsequent further research and normative analysis on the responsible use of AI in clinical settings.

Areas timely for developing research: Future research should clearly outline (i) how physicians must be(come) competent in working with AI in clinical settings, (ii) who or what should take ownership of embedding these competencies in a normative and regulatory framework, (iii) investigate conditions for achieving a reasonable amount of trust in AI, and (iv) assess the connection between trust and efficiency in patient care.

背景:在临床环境中利用人工智能(AI)可能会带来显著的好处。负责任地实施医疗人工智能的一个障碍是,床边对人工智能用户的需求仍然存在不确定性。因此,对临床环境中充分使用人工智能的人类需求的学术文献进行概述具有重要价值。数据来源:对学术文献中提到的医疗人工智能对医生所需能力的潜在影响进行系统回顾。共识领域:我们的研究结果强调了医生的关键人际技能的重要性,以及对技术和数字能力日益增长的需求。争议领域:关于医生在人工智能辅助临床环境中所需能力的具体指导仍然不明确,需要进一步澄清和规范。在能力、技能和专业知识方面,医生是否有足够的能力在临床环境中使用和监测人工智能,关于规范指导的所有权问题,以及医生技能培训,仍然存在分歧。成长要点:我们的综述为后续进一步研究和规范分析在临床环境中负责任地使用人工智能提供了基础。及时开展研究的领域:未来的研究应清楚地概述(i)医生如何在临床环境中有能力与人工智能合作,(ii)谁或什么应该承担将这些能力嵌入规范和监管框架的责任,(iii)调查实现对人工智能的合理信任的条件,以及(iv)评估信任与患者护理效率之间的联系。
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引用次数: 0
Circular RNAs in the management of human osteoporosis. 环状rna在人类骨质疏松症治疗中的应用。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2025-01-16 DOI: 10.1093/bmb/ldae024
Giuseppe Gargano, Simona M Pagano, Nicola Maffulli

Background: Osteoporosis (OP) is a metabolic bone disease producing reduction in bone mass with consequent bone fragility. Circular ribonucleic acid (CircRNA) is a form of RNA that forms a loop structure rather than a linear one. CircRNA can be used for therapeutic purposes, including molecular targets or to test new therapies.

Sources of data: A systematic search of different databases to July 2024 was performed to define the role of circRNA in OP therapy. Seventeen suitable studies were identified.

Areas of agreement: CircRNAs may be useful in studying metabolic processes in OP and identify possible therapeutic targets and new drug therapies.

Areas of controversy: The metabolic processes involved in OP are regulated by many genes and cytokines that can be targeted by CircRNAs. However, it is not easy to predict whether the in vitro responses of the studied CircRNAs and their interaction with drugs are also applicable in vivo.

Growing points: Metabolic processes can be affected by gene dysregulation of CircRNAs on various growth factors. Areas timely for developing research: Despite the predictability of CircRNA pharmacological response in vitro, such pharmacological response cannot be expected to be replicated in vivo.

Data availability: The data that support the findings of this study are available from the corresponding author.

背景:骨质疏松症(OP)是一种代谢性骨病,导致骨量减少,从而导致骨脆性。环状核糖核酸(CircRNA)是一种形成环状结构而不是线性结构的RNA。CircRNA可用于治疗目的,包括分子靶点或测试新疗法。数据来源:对截至2024年7月的不同数据库进行了系统搜索,以确定circRNA在OP治疗中的作用。确定了17项合适的研究。共识领域:CircRNAs可能有助于研究OP的代谢过程,并确定可能的治疗靶点和新的药物疗法。争议领域:OP中涉及的代谢过程受到许多基因和细胞因子的调节,这些基因和细胞因子可以被CircRNAs靶向。然而,所研究的circrna的体外反应及其与药物的相互作用是否也适用于体内,尚不容易预测。生长点:各种生长因子上的circrna基因失调会影响代谢过程。及时开展研究的领域:尽管CircRNA在体外的药理反应是可预测的,但这种药理反应不能期望在体内被复制。数据可得性:支持本研究结果的数据可从通讯作者处获得。
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引用次数: 0
High-volume injections in Achilles tendinopathy: a systematic review. 跟腱病的大容量注射:系统性综述。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-12 DOI: 10.1093/bmb/ldae015
Rifat Hassan, Daryl Poku, Nafisa Miah, Nicola Maffulli

Introduction: Achilles tendinopathy (AT) is common, particularly in runners. High-volume injections (HVIs) may be beneficial in the management of AT compared to other conservative management options, including exercise regimens, platelet-rich plasma (PRP) injections, and extracorporeal shockwave therapy. The published research on the effectiveness of HVI in the treatment of AT was evaluated in this systematic review.

Sources of data: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed when conducting this systematic review. The electronic databases PubMed, Embase, Cochrane, Web of Science, CINAHL, and OVID were thoroughly searched, from inception to 13 September 2023, for articles assessing HVI for AT.

Areas of agreement: A total of 10 studies with 460 participants met the inclusion criteria. HVI typically consisted of saline, local anaesthetic, and corticosteroids. HVI combined with corticosteroids demonstrated immediate and long-term improvements in ankle function. Compared to HVI without corticosteroids, HVI with corticosteroids exhibited greater, early improvements in pain and function, with no significant differences at later follow-up points. Significant reductions in tendon thickness and neovascularity were also found with HVI treatment over time.

Areas of controversy: No adverse events were reported with HVI, despite the use of corticosteroids.

Growing points: HVI is an effective and safe modality, particularly in the short term, to significantly reduce pain and discomfort in the Achilles tendon, especially when supplemented with corticosteroids.

Areas timely for developing research: More robust randomized controlled trials, with longer-term follow-ups and homogeneity, are needed to fully establish its efficacy for AT.

简介跟腱病(AT)很常见,尤其是在跑步者中。与运动疗法、富血小板血浆(PRP)注射和体外冲击波疗法等其他保守治疗方案相比,高容量注射(HVI)可能对跟腱病的治疗有益。本系统性综述对已发表的有关 HVI 治疗 AT 的有效性的研究进行了评估:数据来源:在进行本系统综述时,遵循了《系统综述和元分析首选报告项目》指南。对PubMed、Embase、Cochrane、Web of Science、CINAHL和OVID等电子数据库进行了全面检索,检索时间从开始至2023年9月13日,检索对象为评估HVI治疗AT的文章:共有 10 项研究、460 名参与者符合纳入标准。HVI通常由生理盐水、局麻药和皮质类固醇组成。HVI 联合皮质类固醇可立即和长期改善踝关节功能。与不使用皮质类固醇的踝关节置换术相比,使用皮质类固醇的踝关节置换术在早期对疼痛和功能的改善更大,但在后期的随访中没有明显差异。随着时间的推移,HVI 治疗还能显著减少肌腱厚度和新生血管:争议之处:尽管使用了皮质类固醇,但 HVI 治疗未出现不良反应:成长点:HVI 是一种有效而安全的治疗方式,尤其是在短期内,能显著减轻跟腱的疼痛和不适,特别是在辅以皮质类固醇治疗的情况下:需要更多具有长期随访和同质性的随机对照试验,以充分确定其对跟腱损伤的疗效。
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引用次数: 0
From the archive-Vol 152, Issue 1. 从档案-卷152,第1期。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-12 DOI: 10.1093/bmb/ldae017
Avi A Weinbroum
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引用次数: 0
Bone-patellar tendon-bone, hamstring, and quadriceps tendon autografts for anterior cruciate ligament reconstruction in skeletally immature patients: a systematic review. 骨-髌腱-骨、腘绳肌腱和股四头肌腱自体移植物用于骨骼不成熟患者的前交叉韧带重建:系统性综述。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-12 DOI: 10.1093/bmb/ldae011
Filippo Migliorini, Federico Cocconi, Luise Schäfer, Raju Vaishya, Daniel Kämmer, Nicola Maffulli

Introduction: Historically, anterior cruciate ligament (ACL) ruptures in the paediatric age group were managed conservatively with bracing, casting, activity modification, and physical therapy. However, most of these patients had to reduce their sports activities, and secondary damages to the affected knee were prevalent.

Source of data: Published scientific literature in Embase, Web of Science, PubMed, and Google Scholar databases.

Areas of agreement: ACL reconstruction in children with open physes patients is debated. Any damage to the physes around the knee could lead to growth abnormalities and axial deviation of the knee.

Areas of controversy: Different grafts are available and suitable for ACL reconstruction in skeletally immature patients; however, which graft performs better remains unclear.

Growing points: This systematic review compared bone-patellar tendon-bone (BPTB), hamstring tendon (HT), and quadriceps tendon (QT) autografts for ACL reconstruction in skeletally immature patients. The joint laxity, Patient-reported outcome measures (PROMs), return to sport, and complications were compared.

Areas timely for developing research: In skeletally immature patients, HT, BPTB, and QT autografts for ACL reconstruction yielded good outcomes. Comparative studies are strongly required to establish the most suitable autograft.

导言:一直以来,儿科前十字韧带(ACL)断裂都是通过支架、石膏固定、活动调整和物理疗法等保守治疗。然而,大多数患者不得不减少体育活动,受影响膝关节的二次损伤也很普遍:数据来源:Embase、Web of Science、PubMed 和 Google Scholar 数据库中已发表的科学文献:前交叉韧带重建对于腓骨开放的儿童患者存在争议。任何对膝关节周围韧带的损伤都可能导致生长异常和膝关节轴向偏斜:有不同的移植物可供选择,并适用于骨骼不成熟患者的前交叉韧带重建,但哪种移植物效果更好仍不清楚:本系统综述比较了骨-髌腱-骨(BPTB)、腘绳肌腱(HT)和股四头肌腱(QT)自体移植物用于骨骼不成熟患者的前交叉韧带重建。比较了关节松弛程度、患者报告结果指标(PROMs)、运动恢复情况和并发症:在骨骼尚未发育成熟的患者中,HT、BPTB 和 QT 自体移植物用于前交叉韧带重建取得了良好的效果。要确定最合适的自体移植物,强烈要求进行比较研究。
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引用次数: 0
New developments in the diagnosis and management of motor neuron disease. 运动神经元疾病诊断和管理的新进展。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-12 DOI: 10.1093/bmb/ldae010
David O'Brien, Pamela J Shaw

Introduction: Motor neuron disease (MND) is a devastating neurodegenerative disease characterized by progressive muscle weakness.

Sources of data: PubMed, MEDLINE, and Cochrane databases were searched for articles to March 2024. Searches involved the terms 'motor neuron disease' or 'amyotrophic lateral sclerosis' and 'epidemiology', 'diagnosis', 'clinical', 'genetic', 'management', 'treatment', or 'trial'.

Areas of agreement: Evidence-based management involves riluzole, multidisciplinary care, provision of noninvasive ventilation and gastrostomy, and symptomatic treatments. Tofersen should be offered to treat SOD1-MND.

Areas of controversy: Edaravone and Relyvrio are approved treatments in the USA, but insufficient evidence was found to support approval in the UK and Europe.

Growing points: The discovery of neurofilaments as MND biomarkers, growth of platform trials and development of novel therapies provide optimism for more powerful neuroprotective therapies.

Areas timely for developing research: Further work should focus on the elucidation of environmental causes of MND, gene-environment interactions, and advanced cellular models of disease.

导言:运动神经元病(MND)是一种以进行性肌无力为特征的破坏性神经退行性疾病:对 PubMed、MEDLINE 和 Cochrane 数据库中截至 2024 年 3 月的文章进行了检索。检索词包括 "运动神经元病 "或 "肌萎缩侧索硬化症 "以及 "流行病学"、"诊断"、"临床"、"遗传"、"管理"、"治疗 "或 "试验":基于证据的管理包括利鲁唑、多学科护理、提供无创通气和胃造口术以及对症治疗。在治疗 SOD1-MND 时应使用托非森:依达拉奉(Edaravone)和雷利维奥(Relyvrio)是美国批准的治疗药物,但在英国和欧洲却没有足够的证据支持其获得批准:增长点:作为 MND 生物标志物的神经丝的发现、平台试验的发展和新型疗法的开发为更强大的神经保护疗法提供了乐观的前景:进一步的工作应侧重于阐明 MND 的环境原因、基因与环境的相互作用以及先进的疾病细胞模型。
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引用次数: 0
Pediatric wrist fractures: variations in management across countries. An evidence-based summary of evidence. 小儿腕部骨折:各国在处理上的差异。循证证据摘要。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-12 DOI: 10.1093/bmb/ldae014
Luca Labianca, Cosma Calderaro, Nicola Maffulli

Introduction: Fractures of the distal radius are common in pediatric population, with considerable variation in the management of pediatric wrist fractures across different countries. It is crucial to consider the different approaches to conservative management and surgical intervention. The decision on the appropriate treatment method often depends on the type and severity of the fracture, as well as the available healthcare resources and expertise in each country. This article tries to identify these variations, so the various healthcare systems can work toward implementing best practices in the management of pediatric wrist fractures on a global scale.

Source of data: Published peer-reviewed articles identified in electronic databases, including PubMed Scopus and Google Scholar.

Areas of agreement: The management of pediatric wrist fractures can differ significantly among countries given the high variability in healthcare resources and cultural practices.

Areas of controversy: The management of pediatric wrist fractures can be challenging in certain countries, especially in developing regions with limited resources.

Growing points: Challenges such as long therapeutic delays, lack of appropriate anesthesia, and the absence of fluoroscopy can complicate the treatment process. Randomized controlled clinical trials (RCTs) are vital in providing high-quality evidence to guide clinical decision-making, especially in the field of pediatric wrist fractures.

Areas timely for developing research: Efforts to support and prioritize the conduct and dissemination of RCTs in pediatric wrist fracture management can ultimately lead to more consistent, effective, and evidence-based care for children with wrist fractures worldwide.

导言:桡骨远端骨折是儿科常见疾病,不同国家对小儿腕部骨折的处理方法存在很大差异。考虑保守治疗和手术干预的不同方法至关重要。决定适当的治疗方法通常取决于骨折的类型和严重程度,以及各国现有的医疗资源和专业知识。本文试图找出这些差异,以便各个医疗保健系统在全球范围内实施小儿腕部骨折的最佳治疗方法:数据来源:在电子数据库(包括 PubMed Scopus 和 Google Scholar)中找到的已发表的同行评审文章:鉴于医疗资源和文化习俗的高度差异性,各国对小儿腕部骨折的管理可能存在很大差异:在某些国家,尤其是资源有限的发展中地区,小儿腕部骨折的治疗可能具有挑战性:增长点:治疗延误时间过长、缺乏适当的麻醉和透视技术等挑战会使治疗过程复杂化。随机对照临床试验(RCT)对于提供指导临床决策的高质量证据至关重要,尤其是在小儿腕部骨折领域:支持并优先开展和传播小儿腕部骨折治疗方面的随机对照临床试验,最终可为全球腕部骨折患儿提供更加一致、有效和循证的治疗。
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引用次数: 0
'In this Issue' Volume 152. 本期 "第 152 卷。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-12 DOI: 10.1093/bmb/ldae018
Nicola Maffulli
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引用次数: 0
The athletes heart-from acute stimulus to chronic adaptation. 运动员的心脏从急性刺激到慢性适应。
IF 6.7 2区 医学 Q1 Medicine Pub Date : 2024-12-07 DOI: 10.1093/bmb/ldae021
Joseph D Maxwell, David Oxborough

Introduction: The complex phenomenon of the athlete's heart (AH) describes the chronic physiological structural and functional adaptation secondary to repeated exposure of an acute exercise stimulus.

Sources of data: This narrative review is based on published evidence.

Areas of agreement: Highly trained athletic individuals frequently display cardiac parameters which are suggestive of an AH and can exceed the traditional 'normal' limits.

Area of controversy: The physiological processes underpinning the extent of cardiac adaption and how this is closely linked to exercise type, but also sex, ethnicity, and body size.

Growing points: Since its seminal description by Morganroth and colleagues in 1975, our understanding of the AH has evolved in tandem with improvements in cardiac imaging techniques alongside the exploration of more diverse athletic populations. This narrative review aims to provide a balanced discussion of the multi-factorial nature of structure and function of the AH with specific reference to the unique physiological exercise stimuli.

Areas timely for developing research: Despite great interest in cardiac adaptations across a broad spectrum of athletic populations, future research designs should consider the use of new and novel imaging techniques to enhance our understanding of the acute cardiovascular responses which ultimately mediates such adaptations, especially in athletic populations underrepresented in the literature.

运动员心脏(AH)的复杂现象描述了反复暴露于急性运动刺激后的慢性生理结构和功能适应。数据来源:这篇叙述性综述基于已发表的证据。一致领域:训练有素的运动员经常显示心脏参数,提示AH,可能超过传统的“正常”限制。争论领域:支撑心脏适应程度的生理过程,以及这与运动类型、性别、种族和体型之间的密切关系。成长要点:自从1975年Morganroth和他的同事对AH进行了开创性的描述以来,我们对AH的理解随着心脏成像技术的改进以及对更多样化运动人群的探索而不断发展。这篇综述的目的是提供一个平衡的多因素性质的结构和功能的AH,具体参考独特的生理运动刺激。及时开展研究的领域:尽管在广泛的运动人群中对心脏适应有很大的兴趣,但未来的研究设计应该考虑使用新的和新颖的成像技术来增强我们对最终介导这种适应的急性心血管反应的理解,特别是在文献中代表性不足的运动人群中。
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引用次数: 0
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