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推进研究与治疗:肌痛性脑脊髓炎/慢性疲劳综合征(ME/CFS)临床试验概述及未来展望

Advancing Research and Treatment: An Overview of Clinical Trials in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Future Perspectives.

作者信息

Seton Katharine A, Espejo-Oltra José A, Giménez-Orenga Karen, Haagmans Rik, Ramadan Donia J, Mehlsen Jesper

机构信息

Quadram Institute Bioscience, Norwich Research Park, Norwich NR4 7UQ, UK.

Max Delbrück Center for Molecular Medicine, Robert-Rössle-Straße 10, 13125 Berlin, Germany.

出版信息

J Clin Med. 2024 Jan 6;13(2):325. doi: 10.3390/jcm13020325.

DOI:10.3390/jcm13020325
PMID:38256459
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10816159/
Abstract

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic, debilitating, and multi-faceted illness. Heterogenous onset and clinical presentation with additional comorbidities make it difficult to diagnose, characterize, and successfully treat. Current treatment guidelines focus on symptom management, but with no clear target or causative mechanism, remission rates are low, and fewer than 5% of patients return to their pre-morbid activity levels. Therefore, there is an urgent need to undertake robust clinical trials to identify effective treatments. This review synthesizes insights from clinical trials exploring pharmacological interventions and dietary supplements targeting immunological, metabolic, gastrointestinal, neurological, and neuroendocrine dysfunction in ME/CFS patients which require further exploration. Additionally, the trialling of alternative interventions in ME/CFS based on reported efficacy in the treatment of illnesses with overlapping symptomology is also discussed. Finally, we provide important considerations and make recommendations, focusing on outcome measures, to ensure the execution of future high-quality clinical trials to establish clinical efficacy of evidence-based interventions that are needed for adoption in clinical practice.

摘要

肌痛性脑脊髓炎/慢性疲劳综合征(ME/CFS)是一种慢性、使人衰弱且多方面的疾病。其发病和临床表现具有异质性,还伴有其他合并症,这使得诊断、特征描述及成功治疗都很困难。当前的治疗指南侧重于症状管理,但由于没有明确的靶点或致病机制,缓解率较低,不到5%的患者能恢复到病前的活动水平。因此,迫切需要开展有力的临床试验以确定有效的治疗方法。本综述综合了临床试验的见解,这些试验探索了针对ME/CFS患者免疫、代谢、胃肠道、神经及神经内分泌功能障碍的药物干预和膳食补充剂,这些方面都需要进一步研究。此外,还讨论了基于在治疗具有重叠症状的疾病中所报道的疗效而对ME/CFS进行替代干预的试验情况。最后,我们提供重要的注意事项并给出建议,重点关注结局指标,以确保未来高质量临床试验的实施,从而确立循证干预措施的临床疗效,以便在临床实践中应用。

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