Status of N-of-1 Trials in Chronic Pain Management: A Narrative Review.
Status of N-of-1 Trials in Chronic Pain Management: A Narrative Review.
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DOI：
10.1007/s40122-021-00314-4
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发表时间：
2021-12
期刊：
影响因子：
4
通讯作者：
Li F
中科院分区：
文献类型：
--
作者：
He W;Cui Z;Chen Y;Wang F;Li F
N-of-1 试验是专门针对单个患者进行的随机对照临床试验。 N-of-1 试验的最终目的是优化特定个体的策略。慢性疼痛是一个常见但难治的临床问题。其病因的多样性和患者之间的广泛差异往往导致个体化医疗的需求。因此，慢性疼痛代表了 N-of-1 临床试验的典型病症。研究表明，N-of-1 对患有慢性疼痛、多种合并症和治疗期间不确定变化的患者有益；然而，这种方法尚未成为疼痛诊所的首选。为了剖析 N-of-1 在慢性疼痛管理中的现状及其实施的局限性，我们通过搜索三大数据库（PubMed、ClinicalTrial.gov、Cochrane Library）1985 年至 2020 年间发表的出版物，研究了所有与慢性疼痛相关的 N-of-1 研究。在 35 篇合格论文中，选择了 19 篇进行分析。结果证实，N-of-1试验已经解决了骨关节炎、慢性肌肉骨骼疼痛、神经性疼痛等难治性病例；然而，没有一项试验涉及癌症疼痛。进行N-of-1试验需要研究者付出更长的时间和更多的努力，这不可避免地导致实施困难。值得注意的是，所有招募的试验都是在发达国家进行的。随着移动设备的引入和协议的改进，人们将对实施 N-of-1 试验重新产生兴趣。总的来说，之前低估的“精准医疗”和“执行不力”之间的冲突使 N-of-1 在慢性疼痛管理方面处于一个充满挑战的境地。
N-of-1 trials are randomized controlled clinical trials conducted exclusively on a single patient. The ultimate aim of N-of-1 trials is to optimize a strategy in a particular individual. Chronic pain is a common but refractory clinical problem. Its diverse etiologies and broad variations among patients often lead to the requirement of individualizing medicine. Thus, chronic pain represents a classical condition for N-of-1 clinical trials. Studies have indicated that N-of-1 benefits patients with chronic pain, multiple comorbidities, and uncertain variations during therapies; however, this approach it is not yet adopted as the first choice in pain clinics. To dissect the current status of N-of-1 in chronic pain management, as well as the limitations for its implementation, we herein studied all N-of-1 studies related to chronic pain by searching three major databases (PubMed, ClinicalTrial.gov, Cochrane Library) for publications between 1985 and 2020. Of 35 eligibility papers, 19 were selected for analysis. Results confirmed that N-of-1 trials have solved the refractory cases including osteoarthritis, chronic musculoskeletal pain, and neuropathic pain; however, none of the trials dealt with cancer pain. Longer time and more efforts are needed from investigators when carrying out N-of-1 trials, which inevitably result in implementation difficulties. Of note, all recruited trials were conducted in developed countries. As mobile devices have been introduced and protocols improve, renewed interest in the implementation of N-of-1 trials will occur. Collectively, a previously underestimated conflict between “precision medicine” and “poor implementation” has put N-of-1 in a challenging position for chronic pain management.
影响因子：
2.5
作者：
Alemayehu C;Nikles J;Mitchell G
通讯作者：
Mitchell G